NCT04090736

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

A Randomized Phase III, Multicentre, Open Label Clinical Trial Comparing Azacitidine Plus Pevonedistat Versus Azacitidine in Older/Unfit Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Chemotherapy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prospective, 1:1 randomized multicentre, open label, phase III clinical trial to evaluate efficacy and safety of pevonedistat in combination with azacytidine versus azacytidine in the treatment of naïve adult patients with acute myeloid leukemia who are not eligible for standard induction therapy due to age, co-morbidities or risk-factors. Subjects will be randomized to one of the two treatment arms in a 1:1 ratio, both of which will have treatment cycles of 28 days: * Arm A: Pevonedistat (PEVO) 20 mg/m2 IV on days 1, 3, and 5 plus Azacitidine (AZA) 75 mg/m2 subcutaneous (SC) administered on a 5-on/2-off \[weekend\]/2-on schedule in 28-day cycles (IV AZA can be administered for any patients who have non-tolerated local reactions) * Arm B: AZA 75 mg/m2 SC on a 5-on/2-off \[weekend\]/2-on schedule in 28-day cycle (IV AZA can be administered for any patients who have non-tolerated local reactions) 466 subjects will be randomized in the study. Subjects will continue their study treatment until documented disease progression per Investigator assessment, unacceptable toxicity, withdrawal of consent, or the subject meets other protocol criteria for discontinuation

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-09-24
• Primary completion: 2023-06-30
• Completion: 2025-06-30
• First posted: 2019-09-16
• Last updated: 2025-03-17

Locations

62 sites across 1 country: Spain

Regulatory

• FDA-regulated drug study