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CC-486 and Venetoclax for Acute Myeloid Leukemia

NCT05287568 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-01-15

No results posted yet for this study

Summary

This is an open label, dose escalation Phase I single institution pilot study for relapsed and refractory AML patients using CC-486 (oral azacitidine) with venetoclax. At the completion of dose escalation and after establishment of the MTD or recommended dose of CC-486 with venetoclax, an expansion phase will commence, using venetoclax with the MTD of CC-486 in relapsed/refractory patients.

Conditions

Interventions

DRUG

Venetoclax

Venetoclax is a potent, selective and orally bioavailable small molecule inhibitor of BCL-2 that binds with \> 1,000-fold higher affinity to BCL-2 (Ki \< 0.010 nM) than other apoptotic pathway proteins BCL-XL (Ki = 48 nm) or MCL-1 (Ki \> 444 nM). Leukemia stem cells (LSCs) overexpress BCL-2, and BCL-2 overexpression has been associated with worse outcomes in AML.

DRUG

CC-486

An oral formulation of azacitidine currently being developed for the treatment of hematological and solid malignancies.

Sponsors & Collaborators

Principal Investigators

  • Daniel E Pollyea, MD · University of Colorado, Denver

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-19
Primary Completion
2027-03-23
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT05287568 on ClinicalTrials.gov