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NCT02610777 · REGISTRY CONDITION SEARCH

An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2022-09-19

The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML, or low-blast AML.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Event-Free Survival (EFS)

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outcome · POSTED

Six-month Survival Rate

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outcome · POSTED

One-year Survival Rate

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outcome · POSTED

Time to AML Transformation in HR MDS or CMML Participants

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outcome · POSTED

Percentage of Participants With Complete Remission (CR)

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outcome · POSTED

Percentage of Participants With CR and Partial Remission (PR)

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outcome · POSTED

Percentage of Participants With Overall Response

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outcome · POSTED

Percentage of Participants With CR in Low-blast AML

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outcome · POSTED

Percentage of Participants With CR by Cycle 4

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outcome · POSTED

Percentage of Participants With CR and PR by Cycle 4

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outcome · POSTED

Percentage of Participants With Overall Response by Cycle 4

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outcome · POSTED

Percentage of Participants With CR in Low-blast AML by Cycle 4

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outcome · POSTED

Duration of Complete Remission (CR)

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outcome · POSTED

Duration of Complete Remission (CR) and Partial Remission (PR)

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outcome · POSTED

Duration of Overall Response

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outcome · POSTED

Duration of Complete Remission (CR) in Low-blast AML

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outcome · POSTED

Time to First CR or PR

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outcome · POSTED

Time to Subsequent Therapy

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outcome · POSTED

Percentage of Participants With Red Blood Cells (RBCs) and Platelet-transfusion Independence

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outcome · POSTED

Percentage of Participants With at Least 1 Inpatient Hospital Admissions Related to HR MDS, CMML or Low-blast AML

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outcome · POSTED

Time to Progressive Disease (PD), Relapse, or Death

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outcome · POSTED

Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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outcome · POSTED

Number of Participants in the Safety Analysis Population With Clinically Significant Laboratory Abnormalities Reported as TEAEs

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outcome · POSTED

Number of Participants With Change From Baseline Values in Eastern Cooperative Oncology Group (ECOG) Performance Status

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outcome · POSTED

Number of Participants in the Safety Analysis Population With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Reported as TEAEs

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outcome · POSTED

Number of Participants in the Safety Analysis Population With Clinically Significant Change From Baseline Values in Vital Signs Reported as TEAEs

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: 1. Male or female participants 18 years or older. 2. Morphologically confirmed diagnosis of MDS or nonproliferative CMML (that is, with white blood cells \[WBC\] \<20,000 per microliter \[/mcL\]) or low blast AML based on 1 of the following: French American British (FAB) Classifications: * Refractory anemia with excess blasts (RAEB) - defined as having 5% to 20% myeloblasts in the bone marrow. * CMML with 10% to 19% myeloblasts in the bone marrow and/or 5% to 19% blasts in the blood. OR WHO Classifications: * RAEB 1 - defined as having 5% to 9% myeloblasts in the bone marrow. * RAEB 2 - defined as having 10% to 19% myeloblasts in the bone marrow and/or 5% to 19% blasts in the blood. * CMML 2 - defined as having 10% to 19% myeloblasts in the bone marrow and/or 5% to 19% blasts in the blood. * CMML 1 (Although CMML 1 is defined as having \<10% myeloblasts in the bone marrow and/or \<5% blasts in the blood, these participants may enroll only if bone marrow blasts \>=5%. * WHO defined AML with 20% to 30% myeloblasts in the bone marrow and \<30% myeloblasts in peripheral blood who are deemed by the investigator to be appropriate for azacitidine based therapy. 3. For MDS and CMML participants, prognostic risk category, based on the Revised International Prognostic Scoring System (IPSS R), of: * Very high (\>6 points), * High (\>4.5 to 6 points), or * Intermediate (\>3 to 4.5 points): a participant determined to be in the Intermediate Prognostic Risk Category is only allowable in the setting of \>=5% bone marrow myeloblasts. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Clinical laboratory values within the following parameters (repeat within 3 days before the first dose of study drug if laboratory values used for randomization were obtained more than 3 days before the first dose of study drug): * Albumin \>2.7 g/dL. * Total bilirubin \<upper limit of normal (ULN) except in participants with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll if direct bilirubin \<=1.5\*ULN of the direct bilirubin. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2.5\*ULN. * Creatinine clearance \>=50 milliliter per minutes (mL/min). * Hb \>8 g/dL. Participants may be transfused to achieve this value. Elevated indirect bilirubin due to post transfusion hemolysis is allowed. 6. For CMML participants: WBC count \<20,000/mcL before administration of the first dose of study drug on Cycle 1 Day 1; participants must have been off hydroxyurea for at least 1 week prior to WBC count assessment. 7. Ability to undergo the study required bone marrow sample collection procedures. 8. Suitable venous access for the study required blood sampling (that is, including pharmacokinetic (PK) and biomarker sampling). 9. Female participants who: * Are postmenopausal for at least 1 year before the Screening visit , or * Are surgically sterile, or * If they are of childbearing potential, agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, or * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[example, calendar, ovulation, symptothermal, postovulation methods\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together). Male participants, even if surgically sterilized (that is, status postvasectomy), who: * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[example, calendar, ovulation, symptothermal, postovulation methods for the female partner\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together). 10. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care. Exclusion Criteria: 1. Previous treatment with decitabine or azacitidine or other hypomethylating agent. 2. Acute promyelocytic leukemia as diagnosed by morphologic examination of bone marrow, by fluorescent in situ hybridization or cytogenetics of peripheral blood or bone marrow, or by other accepted analysis. 3. Eligible for allogenic stem cell transplantation. 4. Participants with MDS, CMML, or low blast AML, whose only site of disease is extramedullary, example, the skin. 5. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study procedures or could limit participant expected survival to less than 6 months. 6. Treatment with any anti leukemic/anti MDS therapies (example, lenalidomide, cytarabine, anthracyclines, purine analogs) or with any investigational products within 14 days before the first dose of any study drug. 7. Known hypersensitivity to mannitol. 8. Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia. 9. Major surgery within 14 days before first dose or a scheduled surgery during study period; insertion of a venous access device (example, catheter, port) is not considered major surgery. 10. Diagnosed or treated for another malignancy within 2 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone resection. 11. Life threatening illness unrelated to cancer. 12. Prothrombin time (PT) or prolongation of the activated thromboplastin time (aPTT) \>1.5 ULN or active uncontrolled coagulopathy or bleeding disorder. 13. Known human immunodeficiency virus (HIV) seropositive. 14. Known hepatitis B surface antigen seropositive, or known or suspected active hepatitis C infection. Note: Participants who have isolated positive hepatitis B core antibody (that is, in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. 15. Known hepatic cirrhosis or severe pre-existing hepatic impairment. 16. Known cardiopulmonary disease defined as unstable angina, clinically significant arrhythmia, congestive heart failure (New York Heart Association \[NYHA\] Class III or IV) and/or myocardial infarction within 6 months prior to first dose, or severe pulmonary hypertension. As an example, well controlled atrial fibrillation would not be an exclusion whereas uncontrolled atrial fibrillation would be an exclusion. 17. Treatment with strong cytochrome P450 (CYP) 3A inhibitors or inducers within 14 days before the first dose of study drug. 18. Systemic antineoplastic therapy or radiotherapy for other malignant conditions within 12 months before the first dose of any study drug, except for hydroxyurea. 19. Female participants who are lactating and breast feeding or have a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before first dose of study drug. 20. Female participants who intend to donate eggs (ova) during the course of this study or 4 months after receiving their last dose of study drug(s). 21. Male participants who intend to donate sperm during the course of this study or 4 months after receiving their last dose of study drug(s).
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
    intervention Names
    1. Drug: Azacitidine
    label
    Azacitidine 75 mg/m^2
    type
    ACTIVE_COMPARATOR
  2. description
    Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
    intervention Names
    1. Drug: Azacitidine
    2. Drug: Pevonedistat
    label
    Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Azacitidine 75 mg/m^2
    2. Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
    description
    Azacitidine intravenous or subcutaneous formulation.
    name
    Azacitidine
    type
    DRUG
  2. arm Group Labels
    1. Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
    description
    Pevonedistat intravenous infusion.
    name
    Pevonedistat
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
120
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    OS was defined as the time from the date of randomization to the date of death due to any cause. Participants without documented death at the time of the analysis were censored at the date the participant was last known to be alive. The Kaplan Meier estimates was used for the analysis.
    measure
    Overall Survival (OS)
    time Frame
    From date of randomization until death (up to 3 years and 5 months)
secondary Outcomes
  1. description
    EFS is defined as the time from the date of randomization to the date of the occurrence of an event. An event is defined as death or transformation to AML for HR MDS/CMML participants, whichever occurs first, or defined as death for low-blast AML participants. HR MDS/CMML participants without documented EFS event will be censored at the date of the last response assessment. HR MDS/CMML participants with no response assessment and no death will be censored at the date of randomization. Low-blast AML participants without documentation of death will be censored at the date the participant was last known to be alive. HR MDS/CMML participants who received alternative antineoplastic therapy before death or transformation to AML will be censored at the date of last adequate assessment prior to starting alternate antineoplastic therapy. The Kaplan-Meier estimate was used for the analysis.
    measure
    Event-Free Survival (EFS)
    time Frame
    From date of randomization until transformation to AML, or death due to any cause (up to approximately 5 years)
  2. description
    Kaplan-Meier estimate of probability of OS at the end of the month 6 from randomization.
    measure
    Six-month Survival Rate
    time Frame
    Month 6
  3. description
    Kaplan-Meier estimate of probability of OS at the end of the first year from randomization.
    measure
    One-year Survival Rate
    time Frame
    Month 12
  4. description
    Time to AML transformation in HR MDS and CMML participants is defined as time from randomization to documented AML transformation. Participants without documented AML transformation at the time of the analysis are censored at the date of the last assessment. Participants who died before progression to AML are censored at the date of death. Transformation to AML is defined, according to World Health Organization (WHO) classification, as a participant having \>20% blasts in the blood or marrow and increase of blast count by 50%.
    measure
    Time to AML Transformation in HR MDS or CMML Participants
    time Frame
    From date of randomization until transformation to AML (up to approximately 5 years)
  5. description
    Disease responses for HR MDS or CMML is based on the modified International Working Group (IWG) response criteria for MDS and for low-blast AML on the revised IWG response criteria for AML. CR for HR MDS or CMML: \<= 5% myeloblasts with normal maturation of all cell lines in the bone marrow, and \>= 11 gram/deciliter (g/dL) hemoglobin (Hb), \>=100\*10\^9/liter (/L) platelets (plt), \>=1.0\*10\^9/L absolute neutrophil count (ANC) and 0% blasts in peripheral blood. CR for low-blast AML: morphologic leukemia-free state, ANC of more than 1.0\*10\^9/L and plt of \>=1.0\*10\^9/L, transfusion independence, and no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery for low-blast AML: some participants fulfill all of the criteria for CR except for residual neutropenia (\<1.0\*10\^9/L) or thrombocytopenia (TTP) (\<100\*10\^9/L). The percentages are rounded off to report the nearest whole numbers.
    measure
    Percentage of Participants With Complete Remission (CR)
    time Frame
    From date of randomization until CR (up to approximately 5 years)
  6. description
    Disease responses for HR MDS/CMML per modified IWG response criteria for MDS and for low-blast AML on revised IWG response criteria for AML.CR for HR MDS/CMML: \<=5% myeloblasts with normal maturation of all cell lines in bone marrow ,\>=11 g/dL Hb;\>=100\*10\^9/L plt; \>=1.0\*10\^9/L ANC and 0% blasts in peripheral blood. PR for HR MDS/CMML:considered achieved if all CR criteria is met except for bone marrow blasts decreased by \>=50%over pretreatment but still \>5%. CR for low-blast AML: morphologic leukemia-free state, ANC of \>1.0\*10\^9/L and plt of \>=100\*10\^9/L, transfusion independence, no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery for low-blast AML:fulfill all criteria for CR except for residual neutropenia (\<100\*10\^9/L)/TTP(\<100\*10\^9/L). PR for low-blast AML:all hematological values for CR but with decrease of \>=50% in percentage of blasts to 5%-25% in bone marrow aspirate. The percentages are rounded off to report the nearest whole numbers.
    measure
    Percentage of Participants With CR and Partial Remission (PR)
    time Frame
    From date of randomization until CR and PR (up to approximately 5 years)
  7. description
    Disease responses (HR MDS/CMML): modified IWG criteria for MDS; low-blast (LB) AML: revised IWG criteria for AML. Overall response(HR MDS/CMML)=CR,PR/HI,LB AML=CR+ CR with incomplete blood count recovery(Cri)+PR.HR MDS/CMML-CR:\<=5%myeloblasts with normal maturation of bone marrow (BM) cell lines,\>=11g/dL Hb,\>=100\*10\^9/L plt,\>=1.0\*10\^9/L ANC,0% blasts in peripheral blood; PR:CR criteria met except BM blasts\>=50%less over pretreatment but still\>5%; HI:hb increase (inc)\>=1.5g/dL if baseline\<11g/dL;plt inc\>=30\*10\^9/L if baseline\>20\*10\^9/L/Inc. from \<20\*10\^9/L-\>20\*10\^9/L, ANC inc. by 100%;absolute inc. of\>0.5\*10\^9/L if baseline\<100\*10\^9/L. LB AML-CR:morphologic leukemia-freestate\>1.0\*10\^9ANC,\>=100\*10\^9/L plt, transfusion independence, no residual evidence of extramedullary leukemia;CRi:fulfill CR criteria except residual neutropenia\<1.0\*10\^9/L/TTP\<100\*10\^9/L;PR:all CR hematological values but\>=50%less in BM aspirate. The percentages are rounded off to report the nearest whole numbers.
    measure
    Percentage of Participants With Overall Response
    time Frame
    From date of randomization until CR, PR, or hematologic improvement (HI) (up to approximately 5 years)
  8. description
    Disease response for low-blast AML is based on the revised IWG response criteria for AML. CR for low-blast AML: morphologic leukemia-free state, ANC of more than 1.0\*10\^9/L and plt of \>=1.0\*10\^9/L, transfusion independence, and no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery for low-blast AML: some participants fulfill all of the criteria for CR except for residual neutropenia (\<1.0\*10\^9/L) or thrombocytopenia (TTP) (\<100\*10\^9/L). The percentages are rounded off to report the nearest whole numbers.
    measure
    Percentage of Participants With CR in Low-blast AML
    time Frame
    From date of randomization until CR (up to approximately 5 years)
  9. description
    Disease responses for HR MDS or CMML were based on modified IWG response criteria for MDS and for low-blast AML on revised IWG response criteria for AML. CR for HR MDS or CMML: \<=5% myeloblasts with normal maturation of all cell lines in bone marrow, and \>=11 g/dL Hb, \>=100\*10\^9/L plt, ANC \>=1.0\*10\^9/L and 0% blasts in peripheral blood. CR for low-blast AML: morphologic leukemia-free state, ANC of more than 1.0\*10\^9/L and plt of \>=100\*10\^9/L, transfusion independence, no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery for low-blast AML: some participants fulfill all criteria for CR except for residual neutropenia (\<1.0\*10\^9/L)/TTP (\<100\*10\^9/L). The percentages are rounded off to report the nearest whole numbers.
    measure
    Percentage of Participants With CR by Cycle 4
    time Frame
    From date of randomization until CR by Cycle 4 (cycle length is equal to [=] 28 days)
  10. description
    Disease responses for HR MDS/CMML per modified IWG response criteria for MDS and for low-blast AML on revised IWG response criteria for AML.CR for HR MDS/CMML: \<=5% myeloblasts with normal maturation of all cell lines in bone marrow, \>=11 g/dL Hb; \>=100\*10\^9/L plt; \>=1.0\*10\^9/L ANC and 0% blasts in peripheral blood.PR for HR MDS/CMML: considered achieved if all CR criteria is met except for bone marrow blasts decreased by\>=50% over pretreatment but still\>5%.CR for low-blast AML: morphologic leukemia-free state, ANC of\>1.0\*10\^9/L and plt of\>=100\*10\^9/L, transfusion independence, no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery for low-blast AML: fulfill all criteria for CR except for residual neutropenia (\<100\*10\^9/L)/TTP (\<100\*10\^9/L). PR for low-blast AML: all hematological values for CR but with decrease of \>=50% in percentage of blasts to 5%-25% in bone marrow aspirate. The percentages are rounded off to report the nearest whole numbers.
    measure
    Percentage of Participants With CR and PR by Cycle 4
    time Frame
    From date of randomization until CR and PR, by Cycle 4 (cycle length=28 days)
  11. description
    Disease responses (HR MDS/CMML): modified IWG criteria for MDS; low-blast (LB) AML: revised IWG criteria for AML. Overall response(HR MDS/CMML)=CR,PR/HI,LB AML=CR+ CR with incomplete blood count recovery(Cri)+PR.HR MDS/CMML-CR:\<=5%myeloblasts with normal maturation of bone marrow (BM) cell lines,\>=11g/dL Hb,\>=100\*10\^9/L plt,\>=1.0\*10\^9/L ANC,0% blasts in peripheral blood; PR:CR criteria met except BM blasts\>=50%less over pretreatment but still\>5%; HI:hb increase (inc)\>=1.5g/dL if baseline\<11g/dL;plt inc\>=30\*10\^9/L if baseline\>20\*10\^9/L/Inc. from \<20\*10\^9/L-\>20\*10\^9/L, ANC inc. by 100%;absolute inc. of\>0.5\*10\^9/L if baseline\<100\*10\^9/L. LB AML-CR:morphologic leukemia-freestate\>1.0\*10\^9ANC,\>=100\*10\^9/L plt, transfusion independence, no residual evidence of extramedullary leukemia;CRi:fulfill CR criteria except residual neutropenia\<1.0\*10\^9/L/TTP\<100\*10\^9/L;PR:all CR hematological values but\>=50%less in BM aspirate. The percentages are rounded off to report the nearest whole numbers.
    measure
    Percentage of Participants With Overall Response by Cycle 4
    time Frame
    From date of randomization until CR, PR or HI, by Cycle 4 (cycle length=28 days)
  12. description
    Disease response for low-blast AML is based on revised IWG response criteria for AML. CR for low-blast AML: morphologic leukemia-free state, ANC of more than 1.0\*10\^9/L and ptl of \>=100\*10\^9/L, transfusion independence, no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery for low-blast AML: some participants fulfill all criteria for CR except for residual neutropenia (\<1.0\*10\^9/L)/TTP (\<100\*10\^9/L). The percentages are rounded off to report the nearest whole numbers.
    measure
    Percentage of Participants With CR in Low-blast AML by Cycle 4
    time Frame
    From the date of randomization until CR by Cycle 4 (cycle length=28 days)
Full study description
brief Summary
The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML, or low-blast AML.
detailed Description
The drug being tested in this study is called pevonedistat. Pevonedistat is being tested to treat people with MDS or CMML, or low-blast AML as a combination treatment with azacitidine. This study will look at the overall survival, event free survival and response to treatment in people who take pevonedistat and azacitidine when compared to people who take single-agent azacitidine. The study will enroll 120 participants. Once enrolled, participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups in 28-day treatment cycles: * Pevonedistat 20 mg/m\^2 and azacitidine 75 mg/m\^2 combination * Single-agent azacitidine 75 mg/m\^2 All participants will receive azacitidine via intravenous or subcutaneous route. Participants randomized to the combination arm will also receive pevonedistat intravenous infusion. This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 44 months. Participants will attend the end-of-treatment visit 30 days after the last dose of study drug or before the start of subsequent anti-neoplastic therapy if that occurs sooner. Participants will enter event-free survival follow-up or response follow-up (study visits every 3 months) if their disease has not transformed to AML (for participants with HR MDS or CMML) or progressed (for participants with low-blast AML), and they have not started subsequent therapy. Participants will also enter overall survival follow-up (contacted every 3 months to document subsequent therapies and survival status).
Source references
references
  1. citation
    Sekeres MA, Watts J, Radinoff A, Sangerman MA, Cerrano M, Lopez PF, Zeidner JF, Campelo MD, Graux C, Liesveld J, Selleslag D, Tzvetkov N, Fram RJ, Zhao D, Bell J, Friedlander S, Faller DV, Ades L. Randomized phase 2 trial of pevonedistat plus azacitidine versus azacitidine for higher-risk MDS/CMML or low-blast AML. Leukemia. 2021 Jul;35(7):2119-2124. doi: 10.1038/s41375-021-01125-4. Epub 2021 Jan 22. No abstract available.
    pmid
    33483617
    type
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Source notices and limitations
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