NCT02520011

Alvocidib Biomarker-driven Phase 2 AML Study

Phase 2, Randomized, Biomarker-driven Clinical Study in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With MCL-1 Dependence ≥30%

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this two-stage Phase 2 study is to assess the clinical response (Complete Remission) of ACM (Alvocidib/Cytarabine/Mitoxantrone) compared to CM (Cytarabine/Mitoxantrone) treatment in refractory or relapsed AML patients with demonstrated MCL-1 dependence of ≥ 30% by mitochondrial profiling in bone marrow.

Detailed description

In Stage 1 of the study, all eligible AML patients with demonstrated MCL-1 dependence of ≥ 30% by mitochondrial profiling in bone marrow will receive treatment with ACM. In Stage 2, all eligible AML patients with demonstrated MCL-1 dependence of ≥ 30% by mitochondrial profiling in bone marrow will be randomized 1:1 to receive either treatment with ACM or CM.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Alvocidib
DRUG	Cytarabine
DRUG	Mitoxantrone

Timeline

• Start date: 2016-03-14
• Primary completion: 2020-02-12
• Completion: 2020-02-12
• First posted: 2015-08-11
• Last updated: 2023-11-15
• Results posted: 2021-07-15

Locations

38 sites across 4 countries: United States, Canada, Spain, United Kingdom

Regulatory

• FDA-regulated drug study