AML

Key clinical point: Reduced intensity conditioning (RIC) transplant in first remission vs. chemotherapy alone improved survival in older patients with acute myeloid leukemia (AML) who lacked favorable risk cytogenetics and were considered fit for intensive treatment.

Major finding: During a median follow-up of 60 months from remission, patients receiving RIC transplant vs. no transplant had superior survival (37% vs. 20%; hazard ratio [HR] 0.67; P < .001). Survival benefit with transplant in first remission vs. chemotherapy alone was observed across all Wheatley risk groups (adjusted HR 0.68; P < .001).

Study details: Findings are from the NCRI AML16 trial including 932 patients (age 60-70 years) with AML who entered remission and lacked favorable risk. Of these, 144 underwent RIC transplants from either matched sibling donors (n = 52) or matched unrelated donors (n = 92).

Disclosures: This NCRI AML16 trial was supported by Cancer Research UK. The authors declared no conflict of interests.

Source: Russell NH et al. Haematologica. 2021(Oct 14). Doi: 10.3324/haematol.2021.279010.

Key clinical point: Reduced intensity conditioning (RIC) transplant in first remission vs. chemotherapy alone improved survival in older patients with acute myeloid leukemia (AML) who lacked favorable risk cytogenetics and were considered fit for intensive treatment.

Major finding: During a median follow-up of 60 months from remission, patients receiving RIC transplant vs. no transplant had superior survival (37% vs. 20%; hazard ratio [HR] 0.67; P < .001). Survival benefit with transplant in first remission vs. chemotherapy alone was observed across all Wheatley risk groups (adjusted HR 0.68; P < .001).

Study details: Findings are from the NCRI AML16 trial including 932 patients (age 60-70 years) with AML who entered remission and lacked favorable risk. Of these, 144 underwent RIC transplants from either matched sibling donors (n = 52) or matched unrelated donors (n = 92).

Disclosures: This NCRI AML16 trial was supported by Cancer Research UK. The authors declared no conflict of interests.

Source: Russell NH et al. Haematologica. 2021(Oct 14). Doi: 10.3324/haematol.2021.279010.

Key clinical point: Reduced intensity conditioning (RIC) transplant in first remission vs. chemotherapy alone improved survival in older patients with acute myeloid leukemia (AML) who lacked favorable risk cytogenetics and were considered fit for intensive treatment.

Major finding: During a median follow-up of 60 months from remission, patients receiving RIC transplant vs. no transplant had superior survival (37% vs. 20%; hazard ratio [HR] 0.67; P < .001). Survival benefit with transplant in first remission vs. chemotherapy alone was observed across all Wheatley risk groups (adjusted HR 0.68; P < .001).

Study details: Findings are from the NCRI AML16 trial including 932 patients (age 60-70 years) with AML who entered remission and lacked favorable risk. Of these, 144 underwent RIC transplants from either matched sibling donors (n = 52) or matched unrelated donors (n = 92).

Disclosures: This NCRI AML16 trial was supported by Cancer Research UK. The authors declared no conflict of interests.

Source: Russell NH et al. Haematologica. 2021(Oct 14). Doi: 10.3324/haematol.2021.279010.

Key clinical point: In patients with acute myeloid leukemia (AML), short-term posttransplant outcomes seemed similar in those who achieved first complete remission (CR1) with either first-line therapy with 5-azacitidine combined with venetoclax (aza-ven) or traditional intensive chemotherapy (IC).

Major finding: Rates of 12-month relapse-free survival and overall survival in aza-ven vs. IC groups were 58% vs. 54% and 63.2% vs. 70.8%, respectively. Cumulative incidences of acute graft versus host disease (GVHD) at 6 months and chronic GVHD at 12 months were 58% and 40% in the aza-ven group and 62% and 42% in the IC group, respectively.

Study details: This retrospective study included patients with AML who underwent allogeneic hematopoietic cell transplantation after achieving CR1 with either first-line aza-ven therapy (n = 24) or IC (n = 24).

Disclosures: No source of funding was identified. The authors declared no conflict of interests.

Source: Pasvolsky O et al. Ann Hematol. 2021(Oct 9). Doi: 10.1007/s00277-021-04693-8.

Key clinical point: In patients with acute myeloid leukemia (AML), short-term posttransplant outcomes seemed similar in those who achieved first complete remission (CR1) with either first-line therapy with 5-azacitidine combined with venetoclax (aza-ven) or traditional intensive chemotherapy (IC).

Major finding: Rates of 12-month relapse-free survival and overall survival in aza-ven vs. IC groups were 58% vs. 54% and 63.2% vs. 70.8%, respectively. Cumulative incidences of acute graft versus host disease (GVHD) at 6 months and chronic GVHD at 12 months were 58% and 40% in the aza-ven group and 62% and 42% in the IC group, respectively.

Study details: This retrospective study included patients with AML who underwent allogeneic hematopoietic cell transplantation after achieving CR1 with either first-line aza-ven therapy (n = 24) or IC (n = 24).

Disclosures: No source of funding was identified. The authors declared no conflict of interests.

Source: Pasvolsky O et al. Ann Hematol. 2021(Oct 9). Doi: 10.1007/s00277-021-04693-8.

Key clinical point: In patients with acute myeloid leukemia (AML), short-term posttransplant outcomes seemed similar in those who achieved first complete remission (CR1) with either first-line therapy with 5-azacitidine combined with venetoclax (aza-ven) or traditional intensive chemotherapy (IC).

Major finding: Rates of 12-month relapse-free survival and overall survival in aza-ven vs. IC groups were 58% vs. 54% and 63.2% vs. 70.8%, respectively. Cumulative incidences of acute graft versus host disease (GVHD) at 6 months and chronic GVHD at 12 months were 58% and 40% in the aza-ven group and 62% and 42% in the IC group, respectively.

Study details: This retrospective study included patients with AML who underwent allogeneic hematopoietic cell transplantation after achieving CR1 with either first-line aza-ven therapy (n = 24) or IC (n = 24).

Disclosures: No source of funding was identified. The authors declared no conflict of interests.

Source: Pasvolsky O et al. Ann Hematol. 2021(Oct 9). Doi: 10.1007/s00277-021-04693-8.

Key clinical point: Outpatient vs. inpatient neutropenia management after chemotherapy was not associated with an increased bacteremia incidence, treatment delays, or worse health-related quality of life (HRQoL) in pediatric patients with acute myeloid leukemia (AML).

Major finding: Bacteremia incidence (adjusted risk ratio 0.73; P = .08), mean time to next chemotherapy course (intensification I: adjusted mean difference [D] −1.0; P = .51; intensification II: D −1.5; P = .79), and HRQoL (Pediatric Quality of Life Inventory Generic Core Scales total score: D −2.8; P = .56) were not significantly different with outpatient vs. inpatient neutropenia management.

Study details: This cohort study included 554 pediatric patients with AML who received frontline chemotherapy with either outpatient or inpatient neutropenia management.

Disclosures: This study was supported by Patient-Centered Outcomes Research Institute (PCORI) and partly by an award from the US National Heart, Lung, and Blood Institute (NHLBI) to KD Getz. Some investigators, including the lead author, reported receiving grants and personal fees and being a member of the data safety monitoring board for various sources including PCORI and NHLBI.

Source: Getz KD et al. JAMA Netw Open. 2021(Oct 28). Doi: 10.1001/jamanetworkopen.2021.28385.

Key clinical point: Outpatient vs. inpatient neutropenia management after chemotherapy was not associated with an increased bacteremia incidence, treatment delays, or worse health-related quality of life (HRQoL) in pediatric patients with acute myeloid leukemia (AML).

Major finding: Bacteremia incidence (adjusted risk ratio 0.73; P = .08), mean time to next chemotherapy course (intensification I: adjusted mean difference [D] −1.0; P = .51; intensification II: D −1.5; P = .79), and HRQoL (Pediatric Quality of Life Inventory Generic Core Scales total score: D −2.8; P = .56) were not significantly different with outpatient vs. inpatient neutropenia management.

Study details: This cohort study included 554 pediatric patients with AML who received frontline chemotherapy with either outpatient or inpatient neutropenia management.

Disclosures: This study was supported by Patient-Centered Outcomes Research Institute (PCORI) and partly by an award from the US National Heart, Lung, and Blood Institute (NHLBI) to KD Getz. Some investigators, including the lead author, reported receiving grants and personal fees and being a member of the data safety monitoring board for various sources including PCORI and NHLBI.

Source: Getz KD et al. JAMA Netw Open. 2021(Oct 28). Doi: 10.1001/jamanetworkopen.2021.28385.

Key clinical point: Outpatient vs. inpatient neutropenia management after chemotherapy was not associated with an increased bacteremia incidence, treatment delays, or worse health-related quality of life (HRQoL) in pediatric patients with acute myeloid leukemia (AML).

Major finding: Bacteremia incidence (adjusted risk ratio 0.73; P = .08), mean time to next chemotherapy course (intensification I: adjusted mean difference [D] −1.0; P = .51; intensification II: D −1.5; P = .79), and HRQoL (Pediatric Quality of Life Inventory Generic Core Scales total score: D −2.8; P = .56) were not significantly different with outpatient vs. inpatient neutropenia management.

Study details: This cohort study included 554 pediatric patients with AML who received frontline chemotherapy with either outpatient or inpatient neutropenia management.

Disclosures: This study was supported by Patient-Centered Outcomes Research Institute (PCORI) and partly by an award from the US National Heart, Lung, and Blood Institute (NHLBI) to KD Getz. Some investigators, including the lead author, reported receiving grants and personal fees and being a member of the data safety monitoring board for various sources including PCORI and NHLBI.

Source: Getz KD et al. JAMA Netw Open. 2021(Oct 28). Doi: 10.1001/jamanetworkopen.2021.28385.

Key clinical point: Combination therapy with enasidenib and azacitidine (Ena-AZA) was well tolerated and had a better response rate than azacitidine alone (AZA) in patients with newly diagnosed (ND) mutant-IDH2 acute myeloid leukemia (AML) and ineligible for intensive chemotherapy (IC).

Major finding: The overall response rate was significantly higher in patients receiving Ena-AZA vs. AZA (74% vs. 36%; odds ratio 4.9; P = .0003). The most frequent grade 3 or 4 events in the Ena-AZA vs. AZA groups were thrombocytopenia (37% vs. 19%) and neutropenia (37% vs. 25%).

Study details: Findings are from the phase 2 AG221-AML-005 study including 101 adult patients with ND mutant-IDH2 AML who were ineligible for IC. They were randomly assigned to Ena-AZA (n = 68) or AZA (n = 33).

Disclosures: This study was funded by Celgene, a wholly owned subsidiary of Bristol Myers Squibb (BMS). MG Frattini, P Martin-Regueira, F Lersch, J Gong, and M Hasan reported employment and equity ownership in BMS/Celgene. Other authors reported receiving grants, personal fees, royalties, nonfinancial support, research funding, and honoraria from various sources, including BMS/Celgene.

Source: DiNardo CD et al. Lancet Oncol. 2021;22(11):P1597-P1608 (Oct 18). Doi: 10.1016/S1470-2045(21)00494-0.

Key clinical point: Combination therapy with enasidenib and azacitidine (Ena-AZA) was well tolerated and had a better response rate than azacitidine alone (AZA) in patients with newly diagnosed (ND) mutant-IDH2 acute myeloid leukemia (AML) and ineligible for intensive chemotherapy (IC).

Major finding: The overall response rate was significantly higher in patients receiving Ena-AZA vs. AZA (74% vs. 36%; odds ratio 4.9; P = .0003). The most frequent grade 3 or 4 events in the Ena-AZA vs. AZA groups were thrombocytopenia (37% vs. 19%) and neutropenia (37% vs. 25%).

Study details: Findings are from the phase 2 AG221-AML-005 study including 101 adult patients with ND mutant-IDH2 AML who were ineligible for IC. They were randomly assigned to Ena-AZA (n = 68) or AZA (n = 33).

Disclosures: This study was funded by Celgene, a wholly owned subsidiary of Bristol Myers Squibb (BMS). MG Frattini, P Martin-Regueira, F Lersch, J Gong, and M Hasan reported employment and equity ownership in BMS/Celgene. Other authors reported receiving grants, personal fees, royalties, nonfinancial support, research funding, and honoraria from various sources, including BMS/Celgene.

Source: DiNardo CD et al. Lancet Oncol. 2021;22(11):P1597-P1608 (Oct 18). Doi: 10.1016/S1470-2045(21)00494-0.

Key clinical point: Combination therapy with enasidenib and azacitidine (Ena-AZA) was well tolerated and had a better response rate than azacitidine alone (AZA) in patients with newly diagnosed (ND) mutant-IDH2 acute myeloid leukemia (AML) and ineligible for intensive chemotherapy (IC).

Major finding: The overall response rate was significantly higher in patients receiving Ena-AZA vs. AZA (74% vs. 36%; odds ratio 4.9; P = .0003). The most frequent grade 3 or 4 events in the Ena-AZA vs. AZA groups were thrombocytopenia (37% vs. 19%) and neutropenia (37% vs. 25%).

Study details: Findings are from the phase 2 AG221-AML-005 study including 101 adult patients with ND mutant-IDH2 AML who were ineligible for IC. They were randomly assigned to Ena-AZA (n = 68) or AZA (n = 33).

Disclosures: This study was funded by Celgene, a wholly owned subsidiary of Bristol Myers Squibb (BMS). MG Frattini, P Martin-Regueira, F Lersch, J Gong, and M Hasan reported employment and equity ownership in BMS/Celgene. Other authors reported receiving grants, personal fees, royalties, nonfinancial support, research funding, and honoraria from various sources, including BMS/Celgene.

Source: DiNardo CD et al. Lancet Oncol. 2021;22(11):P1597-P1608 (Oct 18). Doi: 10.1016/S1470-2045(21)00494-0.

A number of late-phase clinical trials in leukemia have opened in recent months. Maybe one of your patients could benefit from being enrolled.

Adults and children with acute or chronic leukemias

A phase 2 study partnering with the National Marrow Donor Program is seeking individuals aged 1-65 years with lymphoma or one of the following leukemias: “acute leukemia”, acute lymphoblastic (ALL), acute myelogenous (AML), mixed-phenotype acute, chronic myelogenous (CML), and chronic lymphocytic (CLL). Researchers hope to find a way to improve outcomes of hematopoietic-cell transplantation from mismatched, unrelated donors. Participants will receive the transplant and one of seven drug regimens and will be followed for a year. The trial plans to enroll 180 people and began recruiting on Sept. 30 in California, New York, and Virginia. The primary outcome is overall survival (OS). Quality of life (QoL) will not be measured.

Mast-cell leukemia (MCL)

Adults with MCL are sought for a phase 2 study of bezuclastinib, an experimental tyrosine-kinase inhibitor (TKI) called CGT9486. CGT9486 blocks the activity of a mutated version of tyrosine-kinase receptor KIT, called KIT D816V, which is known to cause systemic mastocytosis. Participants will receive oral CGT9486 daily for up to 18 months. The study opened in October, aiming for 140 participants with any advanced systemic mastocytoses (including MCL) at sites in California, Florida, Massachusetts, New York, Ohio, Texas, and Utah. OS and QoL will be tracked.

Previously Treated CLL/Small Lymphocytic Lymphoma (SLL)

Patients with CLL/SLL who have progressed on previous therapy can join a phase 3 study of another experimental oral TIK, pirtobrutinib, this time targeting Bruton’s tyrosine kinase (BTK). BTK plays a key role in the lifecycle of white blood cells. Participants will receive either “fixed-duration” pirtobrutinib plus venetoclax (Venclexta) and rituximab (Ruxience, Riabni, Truxima, Rituxan, MabThera) or the venetoclax-rituximab combo only, for up to 5 years. Investigators started recruiting in September, aiming for 600 participants across Florida, Louisiana, Missouri, New York, and Tennessee. Progression-free survival is the primary outcome; OS is a secondary outcome and QoL will not be tracked.

High-grade myeloid cancers with measurable residual disease

Patients with AML, myelodysplastic syndrome with excess blasts-2 or myeloid neoplasm, and whose original disease is still present, are eligible for a phase 2 study of CPX-351 (daunorubicin-cytarabine, Vyxeos). The intravenous chemotherapy was approved in 2017 for certain types of AML. The goal of this study is to determine if pretreatment with CPX-351 improves the outcome of donor stem-cell transplantation. Patients will either undergo immediate transplantation or receive CPX-351 for up to 10 days followed 60 days later by the transplant. The study, being conducted at the Fred Hutchinson Cancer Research Center in Seattle, started recruiting 130 patients in August. The primary outcome is OS; QoL will not be tracked.

Newly diagnosed Philadelphia-negative ALL

Patients aged 22 or older with Philadelphia-negative ALL who have not received chemotherapy or radiation therapy are invited to join a trial of calaspargase pegol (Asparlas). The therapy was approved in 2018 for ALL in children and young adults (1 month to 21 years). The aim of this study is to confirm the recommended doses and evaluate the drug’s safety and pharmacodynamics in adults over aged 21. Each participant will receive six 2-hour infusions of calaspargase pegol over several months. The primary outcomes are safety and drug activity; OS is a secondary outcome and QoL will not be measured. The study opened on July 7 and aims to recruit 122 participants in 11 states.

Untreated adults with TP53-mutant AML

Adult patients with previously untreated AML who have at least one TP53 gene mutation are sought for a phase 3 study of magrolimab, an investigational anti-CD47 monoclonal antibody. Participants will be treated for up to 27 months with either magrolimab plus azacytidine (Vidaza), venetoclax plus azacytidine (patients deemed “appropriate for nonintensive therapy”), or standard chemotherapy (those “appropriate for intensive therapy”). In patients who received nonintensive therapy, OS is the primary outcome; OS in all participants is a secondary outcome, and QoL won’t be assessed. The trial opened in July and aims to recruit 346 individuals in Hong Kong, Australia, and the United States (California, Missouri, Oklahoma, Pennsylvania, South Carolina, and Texas).

All trial information is from the U.S. National Library of Medicine, National Institutes of Health.

A version of this article first appeared on Medscape.com.

A number of late-phase clinical trials in leukemia have opened in recent months. Maybe one of your patients could benefit from being enrolled.

Adults and children with acute or chronic leukemias

A phase 2 study partnering with the National Marrow Donor Program is seeking individuals aged 1-65 years with lymphoma or one of the following leukemias: “acute leukemia”, acute lymphoblastic (ALL), acute myelogenous (AML), mixed-phenotype acute, chronic myelogenous (CML), and chronic lymphocytic (CLL). Researchers hope to find a way to improve outcomes of hematopoietic-cell transplantation from mismatched, unrelated donors. Participants will receive the transplant and one of seven drug regimens and will be followed for a year. The trial plans to enroll 180 people and began recruiting on Sept. 30 in California, New York, and Virginia. The primary outcome is overall survival (OS). Quality of life (QoL) will not be measured.

Mast-cell leukemia (MCL)

Adults with MCL are sought for a phase 2 study of bezuclastinib, an experimental tyrosine-kinase inhibitor (TKI) called CGT9486. CGT9486 blocks the activity of a mutated version of tyrosine-kinase receptor KIT, called KIT D816V, which is known to cause systemic mastocytosis. Participants will receive oral CGT9486 daily for up to 18 months. The study opened in October, aiming for 140 participants with any advanced systemic mastocytoses (including MCL) at sites in California, Florida, Massachusetts, New York, Ohio, Texas, and Utah. OS and QoL will be tracked.

Previously Treated CLL/Small Lymphocytic Lymphoma (SLL)

Patients with CLL/SLL who have progressed on previous therapy can join a phase 3 study of another experimental oral TIK, pirtobrutinib, this time targeting Bruton’s tyrosine kinase (BTK). BTK plays a key role in the lifecycle of white blood cells. Participants will receive either “fixed-duration” pirtobrutinib plus venetoclax (Venclexta) and rituximab (Ruxience, Riabni, Truxima, Rituxan, MabThera) or the venetoclax-rituximab combo only, for up to 5 years. Investigators started recruiting in September, aiming for 600 participants across Florida, Louisiana, Missouri, New York, and Tennessee. Progression-free survival is the primary outcome; OS is a secondary outcome and QoL will not be tracked.

High-grade myeloid cancers with measurable residual disease

Patients with AML, myelodysplastic syndrome with excess blasts-2 or myeloid neoplasm, and whose original disease is still present, are eligible for a phase 2 study of CPX-351 (daunorubicin-cytarabine, Vyxeos). The intravenous chemotherapy was approved in 2017 for certain types of AML. The goal of this study is to determine if pretreatment with CPX-351 improves the outcome of donor stem-cell transplantation. Patients will either undergo immediate transplantation or receive CPX-351 for up to 10 days followed 60 days later by the transplant. The study, being conducted at the Fred Hutchinson Cancer Research Center in Seattle, started recruiting 130 patients in August. The primary outcome is OS; QoL will not be tracked.

Newly diagnosed Philadelphia-negative ALL

Patients aged 22 or older with Philadelphia-negative ALL who have not received chemotherapy or radiation therapy are invited to join a trial of calaspargase pegol (Asparlas). The therapy was approved in 2018 for ALL in children and young adults (1 month to 21 years). The aim of this study is to confirm the recommended doses and evaluate the drug’s safety and pharmacodynamics in adults over aged 21. Each participant will receive six 2-hour infusions of calaspargase pegol over several months. The primary outcomes are safety and drug activity; OS is a secondary outcome and QoL will not be measured. The study opened on July 7 and aims to recruit 122 participants in 11 states.

Untreated adults with TP53-mutant AML

Adult patients with previously untreated AML who have at least one TP53 gene mutation are sought for a phase 3 study of magrolimab, an investigational anti-CD47 monoclonal antibody. Participants will be treated for up to 27 months with either magrolimab plus azacytidine (Vidaza), venetoclax plus azacytidine (patients deemed “appropriate for nonintensive therapy”), or standard chemotherapy (those “appropriate for intensive therapy”). In patients who received nonintensive therapy, OS is the primary outcome; OS in all participants is a secondary outcome, and QoL won’t be assessed. The trial opened in July and aims to recruit 346 individuals in Hong Kong, Australia, and the United States (California, Missouri, Oklahoma, Pennsylvania, South Carolina, and Texas).

All trial information is from the U.S. National Library of Medicine, National Institutes of Health.

A version of this article first appeared on Medscape.com.

A number of late-phase clinical trials in leukemia have opened in recent months. Maybe one of your patients could benefit from being enrolled.

Adults and children with acute or chronic leukemias

A phase 2 study partnering with the National Marrow Donor Program is seeking individuals aged 1-65 years with lymphoma or one of the following leukemias: “acute leukemia”, acute lymphoblastic (ALL), acute myelogenous (AML), mixed-phenotype acute, chronic myelogenous (CML), and chronic lymphocytic (CLL). Researchers hope to find a way to improve outcomes of hematopoietic-cell transplantation from mismatched, unrelated donors. Participants will receive the transplant and one of seven drug regimens and will be followed for a year. The trial plans to enroll 180 people and began recruiting on Sept. 30 in California, New York, and Virginia. The primary outcome is overall survival (OS). Quality of life (QoL) will not be measured.

Mast-cell leukemia (MCL)

Adults with MCL are sought for a phase 2 study of bezuclastinib, an experimental tyrosine-kinase inhibitor (TKI) called CGT9486. CGT9486 blocks the activity of a mutated version of tyrosine-kinase receptor KIT, called KIT D816V, which is known to cause systemic mastocytosis. Participants will receive oral CGT9486 daily for up to 18 months. The study opened in October, aiming for 140 participants with any advanced systemic mastocytoses (including MCL) at sites in California, Florida, Massachusetts, New York, Ohio, Texas, and Utah. OS and QoL will be tracked.

Previously Treated CLL/Small Lymphocytic Lymphoma (SLL)

Patients with CLL/SLL who have progressed on previous therapy can join a phase 3 study of another experimental oral TIK, pirtobrutinib, this time targeting Bruton’s tyrosine kinase (BTK). BTK plays a key role in the lifecycle of white blood cells. Participants will receive either “fixed-duration” pirtobrutinib plus venetoclax (Venclexta) and rituximab (Ruxience, Riabni, Truxima, Rituxan, MabThera) or the venetoclax-rituximab combo only, for up to 5 years. Investigators started recruiting in September, aiming for 600 participants across Florida, Louisiana, Missouri, New York, and Tennessee. Progression-free survival is the primary outcome; OS is a secondary outcome and QoL will not be tracked.

High-grade myeloid cancers with measurable residual disease

Patients with AML, myelodysplastic syndrome with excess blasts-2 or myeloid neoplasm, and whose original disease is still present, are eligible for a phase 2 study of CPX-351 (daunorubicin-cytarabine, Vyxeos). The intravenous chemotherapy was approved in 2017 for certain types of AML. The goal of this study is to determine if pretreatment with CPX-351 improves the outcome of donor stem-cell transplantation. Patients will either undergo immediate transplantation or receive CPX-351 for up to 10 days followed 60 days later by the transplant. The study, being conducted at the Fred Hutchinson Cancer Research Center in Seattle, started recruiting 130 patients in August. The primary outcome is OS; QoL will not be tracked.

Newly diagnosed Philadelphia-negative ALL

Patients aged 22 or older with Philadelphia-negative ALL who have not received chemotherapy or radiation therapy are invited to join a trial of calaspargase pegol (Asparlas). The therapy was approved in 2018 for ALL in children and young adults (1 month to 21 years). The aim of this study is to confirm the recommended doses and evaluate the drug’s safety and pharmacodynamics in adults over aged 21. Each participant will receive six 2-hour infusions of calaspargase pegol over several months. The primary outcomes are safety and drug activity; OS is a secondary outcome and QoL will not be measured. The study opened on July 7 and aims to recruit 122 participants in 11 states.

Untreated adults with TP53-mutant AML

Adult patients with previously untreated AML who have at least one TP53 gene mutation are sought for a phase 3 study of magrolimab, an investigational anti-CD47 monoclonal antibody. Participants will be treated for up to 27 months with either magrolimab plus azacytidine (Vidaza), venetoclax plus azacytidine (patients deemed “appropriate for nonintensive therapy”), or standard chemotherapy (those “appropriate for intensive therapy”). In patients who received nonintensive therapy, OS is the primary outcome; OS in all participants is a secondary outcome, and QoL won’t be assessed. The trial opened in July and aims to recruit 346 individuals in Hong Kong, Australia, and the United States (California, Missouri, Oklahoma, Pennsylvania, South Carolina, and Texas).

All trial information is from the U.S. National Library of Medicine, National Institutes of Health.

A version of this article first appeared on Medscape.com.

This month, two studies reported on the addition of novel therapies to the backbone of low dose cytarabine. The first study, evaluated the role of adding quizartinib to low-dose cytarabine (LDAC) in older patients with acute myeloid leukemia (AML) not suitable for intensive chemotherapy. The addition of quizartinib to LDAC vs. LDAC alone improved survival and response in older patients with AML with an FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) mutation who were unfit for intensive chemotherapy (IC). Among patients with FLT3-ITD mutation, LDAC+quizartinib improved response in 38% of patients vs. 0% of patients receiving LDAC alone (P = .02). The 2-year overall survival also improved significantly in patients receiving LDAC+quizartinib (hazard ratio [HR] 0.36; P = .024). The study included 202 older patients with AML (de novo AML 63%; secondary AML 25%; high-risk myelodysplastic syndrome 11%) unsuitable for IC with (n = 27) or without FLT3-ITD mutation randomly assigned to receive LDAC+quizartinib or LDAC alone.¹

The second study evaluated the combination of LDAC with venetoclax vs. placebo in treatment-naive patients with AML ineligible for IC. LDAC+venetoclax vs. LDAC+placebo improved median overall survival (HR 0.70; P = .04), along with higher rates of complete response (CR) or CR with incomplete hematologic recovery (CRi) (48.3% vs. 13.2%; P < .001) and postbaseline red blood cell and platelet transfusion independence (39.2% vs. 17.6%; P = .002). This was a post hoc analysis performed after an additional 6 months of follow-up of the phase 3 VIALE-C trial, including 211 adult patients with AML who were treatment-naive and unsuitable for IC. Patients were randomly assigned to receive LDAC with venetoclax (n = 143) or placebo (n = 68).²This study was previously reported with a shorter follow up and ddi not demonstrate a survival difference for LDAC+venetoclax vs. LDAC alone. It is very reassuring to see these results with longer follow-up with an improvement of the median overall survival from 4.1 months with LDAC alone to 8.4 months with LDAC+venetoclax. In addition, responses were seen in patients who had prior hypomethylating agents. The CR, CR/CRi and CR/CR with partial hematologic recovery (CRh) rates were 7%, 29%, and 21% respectively.

Finally in a study by Roboz et al. patients who received oral azacytidine as maintenance had no worsening of fatigue or health-related quality of life. Maintenance therapy with oral azacitidine (oral-AZA) did not negatively affect fatigue and health-related quality of life (HrQoL) in patients with acute myeloid leukemia (AML) in complete remission (CR) or CR with incomplete hematologic recovery (CRi) after intensive chemotherapy (IC). Effects of oral-AZA on fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue: difference in overall least square mean change [D] −0.89; 95% CI −2.37- 0.59) and HrQoL (EQ-5D-3L health utility index: D −0.01; 95% CI, −0.03-0.01; EQ-5D visual analog: D −0.95; 95% CI, −4.38-2.47) were comparable to placebo. Findings are from the QUAZAR AML-001 trial, including 444 patients with AML with intermediate- or poor-risk cytogenetics at diagnosis and unsuitable for transplantation. The patients were randomly assigned to receive either oral-AZA (n = 225) or placebo (n = 219) in first CR/CRi after IC. One caveat is that the assessments were performed on Day 1 of each 28 day cycle, which may have allowed for the recovery from side effects of oral azacytidine.³

References

1. Dennis M et al. Randomised evaluation of quizartinib and low-dose ara-C vs low-dose ara-C in older acute myeloid leukemia patients. Blood Adv. 2021 Oct 1.
2. Wei AH et al. 6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy. Blood Cancer J. 2021;11:163.
3. Roboz GJ et al. Oral azacitidine preserves favorable level of fatigue and health-related quality of life for patients with acute myeloid leukemia in remission: results from the phase 3, placebo-controlled QUAZAR AML-001 trial. Haematologica. 2021 Sep 23.

This month, two studies reported on the addition of novel therapies to the backbone of low dose cytarabine. The first study, evaluated the role of adding quizartinib to low-dose cytarabine (LDAC) in older patients with acute myeloid leukemia (AML) not suitable for intensive chemotherapy. The addition of quizartinib to LDAC vs. LDAC alone improved survival and response in older patients with AML with an FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) mutation who were unfit for intensive chemotherapy (IC). Among patients with FLT3-ITD mutation, LDAC+quizartinib improved response in 38% of patients vs. 0% of patients receiving LDAC alone (P = .02). The 2-year overall survival also improved significantly in patients receiving LDAC+quizartinib (hazard ratio [HR] 0.36; P = .024). The study included 202 older patients with AML (de novo AML 63%; secondary AML 25%; high-risk myelodysplastic syndrome 11%) unsuitable for IC with (n = 27) or without FLT3-ITD mutation randomly assigned to receive LDAC+quizartinib or LDAC alone.¹

The second study evaluated the combination of LDAC with venetoclax vs. placebo in treatment-naive patients with AML ineligible for IC. LDAC+venetoclax vs. LDAC+placebo improved median overall survival (HR 0.70; P = .04), along with higher rates of complete response (CR) or CR with incomplete hematologic recovery (CRi) (48.3% vs. 13.2%; P < .001) and postbaseline red blood cell and platelet transfusion independence (39.2% vs. 17.6%; P = .002). This was a post hoc analysis performed after an additional 6 months of follow-up of the phase 3 VIALE-C trial, including 211 adult patients with AML who were treatment-naive and unsuitable for IC. Patients were randomly assigned to receive LDAC with venetoclax (n = 143) or placebo (n = 68).²This study was previously reported with a shorter follow up and ddi not demonstrate a survival difference for LDAC+venetoclax vs. LDAC alone. It is very reassuring to see these results with longer follow-up with an improvement of the median overall survival from 4.1 months with LDAC alone to 8.4 months with LDAC+venetoclax. In addition, responses were seen in patients who had prior hypomethylating agents. The CR, CR/CRi and CR/CR with partial hematologic recovery (CRh) rates were 7%, 29%, and 21% respectively.

Finally in a study by Roboz et al. patients who received oral azacytidine as maintenance had no worsening of fatigue or health-related quality of life. Maintenance therapy with oral azacitidine (oral-AZA) did not negatively affect fatigue and health-related quality of life (HrQoL) in patients with acute myeloid leukemia (AML) in complete remission (CR) or CR with incomplete hematologic recovery (CRi) after intensive chemotherapy (IC). Effects of oral-AZA on fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue: difference in overall least square mean change [D] −0.89; 95% CI −2.37- 0.59) and HrQoL (EQ-5D-3L health utility index: D −0.01; 95% CI, −0.03-0.01; EQ-5D visual analog: D −0.95; 95% CI, −4.38-2.47) were comparable to placebo. Findings are from the QUAZAR AML-001 trial, including 444 patients with AML with intermediate- or poor-risk cytogenetics at diagnosis and unsuitable for transplantation. The patients were randomly assigned to receive either oral-AZA (n = 225) or placebo (n = 219) in first CR/CRi after IC. One caveat is that the assessments were performed on Day 1 of each 28 day cycle, which may have allowed for the recovery from side effects of oral azacytidine.³

References

1. Dennis M et al. Randomised evaluation of quizartinib and low-dose ara-C vs low-dose ara-C in older acute myeloid leukemia patients. Blood Adv. 2021 Oct 1.
2. Wei AH et al. 6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy. Blood Cancer J. 2021;11:163.
3. Roboz GJ et al. Oral azacitidine preserves favorable level of fatigue and health-related quality of life for patients with acute myeloid leukemia in remission: results from the phase 3, placebo-controlled QUAZAR AML-001 trial. Haematologica. 2021 Sep 23.

This month, two studies reported on the addition of novel therapies to the backbone of low dose cytarabine. The first study, evaluated the role of adding quizartinib to low-dose cytarabine (LDAC) in older patients with acute myeloid leukemia (AML) not suitable for intensive chemotherapy. The addition of quizartinib to LDAC vs. LDAC alone improved survival and response in older patients with AML with an FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) mutation who were unfit for intensive chemotherapy (IC). Among patients with FLT3-ITD mutation, LDAC+quizartinib improved response in 38% of patients vs. 0% of patients receiving LDAC alone (P = .02). The 2-year overall survival also improved significantly in patients receiving LDAC+quizartinib (hazard ratio [HR] 0.36; P = .024). The study included 202 older patients with AML (de novo AML 63%; secondary AML 25%; high-risk myelodysplastic syndrome 11%) unsuitable for IC with (n = 27) or without FLT3-ITD mutation randomly assigned to receive LDAC+quizartinib or LDAC alone.¹

The second study evaluated the combination of LDAC with venetoclax vs. placebo in treatment-naive patients with AML ineligible for IC. LDAC+venetoclax vs. LDAC+placebo improved median overall survival (HR 0.70; P = .04), along with higher rates of complete response (CR) or CR with incomplete hematologic recovery (CRi) (48.3% vs. 13.2%; P < .001) and postbaseline red blood cell and platelet transfusion independence (39.2% vs. 17.6%; P = .002). This was a post hoc analysis performed after an additional 6 months of follow-up of the phase 3 VIALE-C trial, including 211 adult patients with AML who were treatment-naive and unsuitable for IC. Patients were randomly assigned to receive LDAC with venetoclax (n = 143) or placebo (n = 68).²This study was previously reported with a shorter follow up and ddi not demonstrate a survival difference for LDAC+venetoclax vs. LDAC alone. It is very reassuring to see these results with longer follow-up with an improvement of the median overall survival from 4.1 months with LDAC alone to 8.4 months with LDAC+venetoclax. In addition, responses were seen in patients who had prior hypomethylating agents. The CR, CR/CRi and CR/CR with partial hematologic recovery (CRh) rates were 7%, 29%, and 21% respectively.

Finally in a study by Roboz et al. patients who received oral azacytidine as maintenance had no worsening of fatigue or health-related quality of life. Maintenance therapy with oral azacitidine (oral-AZA) did not negatively affect fatigue and health-related quality of life (HrQoL) in patients with acute myeloid leukemia (AML) in complete remission (CR) or CR with incomplete hematologic recovery (CRi) after intensive chemotherapy (IC). Effects of oral-AZA on fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue: difference in overall least square mean change [D] −0.89; 95% CI −2.37- 0.59) and HrQoL (EQ-5D-3L health utility index: D −0.01; 95% CI, −0.03-0.01; EQ-5D visual analog: D −0.95; 95% CI, −4.38-2.47) were comparable to placebo. Findings are from the QUAZAR AML-001 trial, including 444 patients with AML with intermediate- or poor-risk cytogenetics at diagnosis and unsuitable for transplantation. The patients were randomly assigned to receive either oral-AZA (n = 225) or placebo (n = 219) in first CR/CRi after IC. One caveat is that the assessments were performed on Day 1 of each 28 day cycle, which may have allowed for the recovery from side effects of oral azacytidine.³

References

1. Dennis M et al. Randomised evaluation of quizartinib and low-dose ara-C vs low-dose ara-C in older acute myeloid leukemia patients. Blood Adv. 2021 Oct 1.
2. Wei AH et al. 6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy. Blood Cancer J. 2021;11:163.
3. Roboz GJ et al. Oral azacitidine preserves favorable level of fatigue and health-related quality of life for patients with acute myeloid leukemia in remission: results from the phase 3, placebo-controlled QUAZAR AML-001 trial. Haematologica. 2021 Sep 23.

Key clinical point: A dose of 300 mg secukinumab was more effective than 150 mg secukinumab, along with a similar safety profile in patients with psoriatic arthritis (PsA), particularly those who had an inadequate response to tumor necrosis factor inhibitors (anti-TNF-IR).

Major finding: At week 24, 20% or higher improvement in American College of Rheumatology (ACR20) response (odds ratio [OR] 1.41; P = .01) and resolution of dactylitis (OR 1.42; P = .02) was higher with 300 mg vs. 150 mg secukinumab. The proportion of ACR20 responders was higher with 300 mg vs. 150 mg secukinumab in anti-TNF-IR patients at weeks 24 (OR 1.75; P = .01) and 52 (OR 1.66; P = .01). The risk for adverse events was similar with both doses.

Study details: Findings are from a meta-analysis of 6 studies including 3 randomized controlled trials and 1,141 patients with PsA that compared 300 mg secukinumab (n = 461) vs. 150 mg secukinumab (n = 680).

Disclosures: This study did not report any source of funding. The authors declared no conflict of interests.

Source: Zhang KL et al. Clinics (Sao Paulo). 2021 (Sep 20);76:e2820. doi: 10.6061/clinics/2021/e2820.

Key clinical point: A dose of 300 mg secukinumab was more effective than 150 mg secukinumab, along with a similar safety profile in patients with psoriatic arthritis (PsA), particularly those who had an inadequate response to tumor necrosis factor inhibitors (anti-TNF-IR).

Major finding: At week 24, 20% or higher improvement in American College of Rheumatology (ACR20) response (odds ratio [OR] 1.41; P = .01) and resolution of dactylitis (OR 1.42; P = .02) was higher with 300 mg vs. 150 mg secukinumab. The proportion of ACR20 responders was higher with 300 mg vs. 150 mg secukinumab in anti-TNF-IR patients at weeks 24 (OR 1.75; P = .01) and 52 (OR 1.66; P = .01). The risk for adverse events was similar with both doses.

Study details: Findings are from a meta-analysis of 6 studies including 3 randomized controlled trials and 1,141 patients with PsA that compared 300 mg secukinumab (n = 461) vs. 150 mg secukinumab (n = 680).

Disclosures: This study did not report any source of funding. The authors declared no conflict of interests.

Source: Zhang KL et al. Clinics (Sao Paulo). 2021 (Sep 20);76:e2820. doi: 10.6061/clinics/2021/e2820.

Key clinical point: A dose of 300 mg secukinumab was more effective than 150 mg secukinumab, along with a similar safety profile in patients with psoriatic arthritis (PsA), particularly those who had an inadequate response to tumor necrosis factor inhibitors (anti-TNF-IR).

Major finding: At week 24, 20% or higher improvement in American College of Rheumatology (ACR20) response (odds ratio [OR] 1.41; P = .01) and resolution of dactylitis (OR 1.42; P = .02) was higher with 300 mg vs. 150 mg secukinumab. The proportion of ACR20 responders was higher with 300 mg vs. 150 mg secukinumab in anti-TNF-IR patients at weeks 24 (OR 1.75; P = .01) and 52 (OR 1.66; P = .01). The risk for adverse events was similar with both doses.

Study details: Findings are from a meta-analysis of 6 studies including 3 randomized controlled trials and 1,141 patients with PsA that compared 300 mg secukinumab (n = 461) vs. 150 mg secukinumab (n = 680).

Disclosures: This study did not report any source of funding. The authors declared no conflict of interests.

Source: Zhang KL et al. Clinics (Sao Paulo). 2021 (Sep 20);76:e2820. doi: 10.6061/clinics/2021/e2820.

Key clinical point: Risk classification at acute myeloid leukemia (AML) diagnosis predicted clinical outcomes in patients with or without KMT2A-rearranged AML who underwent allogeneic hematopoietic cell transplant (HCT) in the first complete remission (CR1).

Major finding: Transplanted patients with KMT2A-rearranged and adverse-risk AML had worse overall survival (hazard ratio [HR] 1.32, and HR 1.45; both P < .001, respectively), leukemia-free survival (HR 1.26; P = .002, and HR 1.47; P < .001, respectively), and relapse (HR 1.27; P = .01, and HR 1.71; P < .001, respectively) vs. patients with intermediate-risk AML.

Study details: This retrospective registry-based study included 3,779 adult patients with KMT2A-rearranged (n = 426), non-KMT2A intermediate-risk (n = 2,384), or non-KMT2A adverse risk (n = 969) AML who underwent HCT in CR1.

Disclosures: This study was funded by Weinberg Family and Mortimer J. Lacher fellowships, American Society of Clinical Oncology Young Investigator Award, National Institutes of Health K12 Paul Calabresi Career Development Award for Clinical Oncology, and others. Some investigators reported receiving personal fees, grants, nonfinancial support, research collaboration, owning stocks, or other relations with various sources including pharmaceutical companies not connected with this study.

Source: Menghrajani K et al. Blood Adv. 2021 Sep 22. doi: 10.1182/bloodadvances.2021004881.

Key clinical point: Risk classification at acute myeloid leukemia (AML) diagnosis predicted clinical outcomes in patients with or without KMT2A-rearranged AML who underwent allogeneic hematopoietic cell transplant (HCT) in the first complete remission (CR1).

Major finding: Transplanted patients with KMT2A-rearranged and adverse-risk AML had worse overall survival (hazard ratio [HR] 1.32, and HR 1.45; both P < .001, respectively), leukemia-free survival (HR 1.26; P = .002, and HR 1.47; P < .001, respectively), and relapse (HR 1.27; P = .01, and HR 1.71; P < .001, respectively) vs. patients with intermediate-risk AML.

Study details: This retrospective registry-based study included 3,779 adult patients with KMT2A-rearranged (n = 426), non-KMT2A intermediate-risk (n = 2,384), or non-KMT2A adverse risk (n = 969) AML who underwent HCT in CR1.

Disclosures: This study was funded by Weinberg Family and Mortimer J. Lacher fellowships, American Society of Clinical Oncology Young Investigator Award, National Institutes of Health K12 Paul Calabresi Career Development Award for Clinical Oncology, and others. Some investigators reported receiving personal fees, grants, nonfinancial support, research collaboration, owning stocks, or other relations with various sources including pharmaceutical companies not connected with this study.

Source: Menghrajani K et al. Blood Adv. 2021 Sep 22. doi: 10.1182/bloodadvances.2021004881.

Key clinical point: Risk classification at acute myeloid leukemia (AML) diagnosis predicted clinical outcomes in patients with or without KMT2A-rearranged AML who underwent allogeneic hematopoietic cell transplant (HCT) in the first complete remission (CR1).

Major finding: Transplanted patients with KMT2A-rearranged and adverse-risk AML had worse overall survival (hazard ratio [HR] 1.32, and HR 1.45; both P < .001, respectively), leukemia-free survival (HR 1.26; P = .002, and HR 1.47; P < .001, respectively), and relapse (HR 1.27; P = .01, and HR 1.71; P < .001, respectively) vs. patients with intermediate-risk AML.

Study details: This retrospective registry-based study included 3,779 adult patients with KMT2A-rearranged (n = 426), non-KMT2A intermediate-risk (n = 2,384), or non-KMT2A adverse risk (n = 969) AML who underwent HCT in CR1.

Disclosures: This study was funded by Weinberg Family and Mortimer J. Lacher fellowships, American Society of Clinical Oncology Young Investigator Award, National Institutes of Health K12 Paul Calabresi Career Development Award for Clinical Oncology, and others. Some investigators reported receiving personal fees, grants, nonfinancial support, research collaboration, owning stocks, or other relations with various sources including pharmaceutical companies not connected with this study.

Source: Menghrajani K et al. Blood Adv. 2021 Sep 22. doi: 10.1182/bloodadvances.2021004881.

Key clinical point: Maintenance therapy with oral azacitidine (oral-AZA) did not compromise on fatigue and health-related quality of life (HrQoL) in patients with acute myeloid leukemia (AML) in complete remission (CR) or CR with incomplete hematologic recovery (CRi) after intensive chemotherapy (IC).

Major finding: Effects of oral-AZA on fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue: difference in overall least square mean change [D] −0.89; 95% CI −2.37- 0.59) and HrQoL (EQ-5D-3L health utility index: D −0.01; 95% CI, −0.03-0.01; EQ-5D visual analog: D −0.95; 95% CI, −4.38-2.47) were comparable to placebo.

Study details: Findings are from the QUAZAR AML-001 trial, including 444 patients with AML with intermediate- or poor-risk cytogenetics at diagnosis and unsuitable for transplantation. The patients were randomly assigned to receive either oral-AZA (n = 225) or placebo (n = 219) in first CR/CRi after IC.

Disclosures: This study was funded by Celgene, a Bristol Myers Squibb (BMS) Company. Some investigators, including the lead author, reported receiving research/personal support or consulting from, being an employee of, and owning equity in various sources, including Celgene and BMS.

Source: Roboz GJ et al. Haematologica. 2021 Sep 23. doi: 10.3324/haematol.2021.279174.

Key clinical point: Maintenance therapy with oral azacitidine (oral-AZA) did not compromise on fatigue and health-related quality of life (HrQoL) in patients with acute myeloid leukemia (AML) in complete remission (CR) or CR with incomplete hematologic recovery (CRi) after intensive chemotherapy (IC).

Major finding: Effects of oral-AZA on fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue: difference in overall least square mean change [D] −0.89; 95% CI −2.37- 0.59) and HrQoL (EQ-5D-3L health utility index: D −0.01; 95% CI, −0.03-0.01; EQ-5D visual analog: D −0.95; 95% CI, −4.38-2.47) were comparable to placebo.

Study details: Findings are from the QUAZAR AML-001 trial, including 444 patients with AML with intermediate- or poor-risk cytogenetics at diagnosis and unsuitable for transplantation. The patients were randomly assigned to receive either oral-AZA (n = 225) or placebo (n = 219) in first CR/CRi after IC.

Disclosures: This study was funded by Celgene, a Bristol Myers Squibb (BMS) Company. Some investigators, including the lead author, reported receiving research/personal support or consulting from, being an employee of, and owning equity in various sources, including Celgene and BMS.

Source: Roboz GJ et al. Haematologica. 2021 Sep 23. doi: 10.3324/haematol.2021.279174.

Key clinical point: Maintenance therapy with oral azacitidine (oral-AZA) did not compromise on fatigue and health-related quality of life (HrQoL) in patients with acute myeloid leukemia (AML) in complete remission (CR) or CR with incomplete hematologic recovery (CRi) after intensive chemotherapy (IC).

Major finding: Effects of oral-AZA on fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue: difference in overall least square mean change [D] −0.89; 95% CI −2.37- 0.59) and HrQoL (EQ-5D-3L health utility index: D −0.01; 95% CI, −0.03-0.01; EQ-5D visual analog: D −0.95; 95% CI, −4.38-2.47) were comparable to placebo.

Study details: Findings are from the QUAZAR AML-001 trial, including 444 patients with AML with intermediate- or poor-risk cytogenetics at diagnosis and unsuitable for transplantation. The patients were randomly assigned to receive either oral-AZA (n = 225) or placebo (n = 219) in first CR/CRi after IC.

Disclosures: This study was funded by Celgene, a Bristol Myers Squibb (BMS) Company. Some investigators, including the lead author, reported receiving research/personal support or consulting from, being an employee of, and owning equity in various sources, including Celgene and BMS.

Source: Roboz GJ et al. Haematologica. 2021 Sep 23. doi: 10.3324/haematol.2021.279174.

Key clinical point: The source of COVID-19 in most patients with acute myeloid leukemia (AML) was presumed to be in-hospital transmission with mortality because COVID-19 was higher in patients with active disease than those in remission.

Major finding: The source of infection was in-hospital transmission in 63% of cases. The overall rate of mortality was 54.5%, with a higher incidence in patients with active AML vs. those in AML remission (83% vs. 17%; P = .0052).

Study details: This retrospective survey evaluated the response of 10 Brazilian hematologists representing 10 cancer centers, providing data on 33 adult patients with either active AML (n = 20) or in AML remission (n = 13) and a confirmed COVID-19 diagnosis. The patients were admitted to the hospital mainly through urgent or emergency care units.

Disclosures: No source of funding was identified. The authors declared no conflict of interests.

Source: Fagundes EM et al. Ann Hematol. 2021 Sep 17. doi:  10.1007/s00277-021-04659-w.

Key clinical point: The source of COVID-19 in most patients with acute myeloid leukemia (AML) was presumed to be in-hospital transmission with mortality because COVID-19 was higher in patients with active disease than those in remission.

Major finding: The source of infection was in-hospital transmission in 63% of cases. The overall rate of mortality was 54.5%, with a higher incidence in patients with active AML vs. those in AML remission (83% vs. 17%; P = .0052).

Study details: This retrospective survey evaluated the response of 10 Brazilian hematologists representing 10 cancer centers, providing data on 33 adult patients with either active AML (n = 20) or in AML remission (n = 13) and a confirmed COVID-19 diagnosis. The patients were admitted to the hospital mainly through urgent or emergency care units.

Disclosures: No source of funding was identified. The authors declared no conflict of interests.

Source: Fagundes EM et al. Ann Hematol. 2021 Sep 17. doi:  10.1007/s00277-021-04659-w.

Key clinical point: The source of COVID-19 in most patients with acute myeloid leukemia (AML) was presumed to be in-hospital transmission with mortality because COVID-19 was higher in patients with active disease than those in remission.

Major finding: The source of infection was in-hospital transmission in 63% of cases. The overall rate of mortality was 54.5%, with a higher incidence in patients with active AML vs. those in AML remission (83% vs. 17%; P = .0052).

Study details: This retrospective survey evaluated the response of 10 Brazilian hematologists representing 10 cancer centers, providing data on 33 adult patients with either active AML (n = 20) or in AML remission (n = 13) and a confirmed COVID-19 diagnosis. The patients were admitted to the hospital mainly through urgent or emergency care units.

Disclosures: No source of funding was identified. The authors declared no conflict of interests.

Source: Fagundes EM et al. Ann Hematol. 2021 Sep 17. doi:  10.1007/s00277-021-04659-w.