Clinical Trial

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

Study acronym: PEVOLAM
Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 36 amendments
This ClinicalTrials.gov record has been amended 36 times since 2019-09-12; most recent amendment 2026-06-23.
Status change: Recruiting → Active, Not Recruiting 2022-09-09
Trial Details
NCT Number NCT04090736
Lead Sponsor PETHEMA Foundation
Collaborators: Millennium Pharmaceuticals, Inc., Dynamic Science S.L.
Conditions Leukemia, Myeloid, Acute
Enrollment 302 participants
Start Date 2019-09-24
Primary Completion 2023-06-30 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-25