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Study to Compare Azacitidine Plus Pevonedistat Versus Azacitidine in Patients With Acute Myeloid Leukemia Not Eligible for Standard Chemotherapy

NCT04090736 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2025-03-17

No results posted yet for this study

Summary

Randomized phase III, multicentre, open label clinical trial to compare pevonedistat in combination with azacytidine versus azacytidine alone, which can be considered a standard of care for patients with newly diagnosed acute myeloid leukemia not eligible for intensive chemotherapy (thus not eligible for an allogeneic hematopoietic stem cell transplant.

Conditions

  • Leukemia, Myeloid, Acute

Interventions

DRUG

Pevonedistat

Pevonedistat 20 mg/m2 intravenous on days 1, 3, and 5 (28-day cycles)

DRUG

Azacitidine

Azacitidine 75 mg/m2 subcutaneous on a 5-on/2-off \[weekend\]/2-on schedule (28-day cycle). Intravenous for patients who have non-tolerated local reactions

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Dynamic Science S.L.

    collaborator INDUSTRY

  • PETHEMA Foundation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-24
Primary Completion
2023-06-30
Completion
2025-06-30
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04090736 on ClinicalTrials.gov