CC-486 and Venetoclax for Acute Myeloid Leukemia

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05287568
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    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.
  • CC-486 — DRUG
    An oral formulation of azacitidine currently being developed for the treatment of hematological and solid malignancies.

Study Details

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.

Key Dates

Start date
Dec 19, 2022
Status verified
Jan 2026
Primary completion
Mar 23, 2027
Completion
Mar 31, 2029

Study Design

Enrollment
35 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 CC-486 200 mg
    CC-486 200 mg will be administered orally on days 1-14 of a 28-day cycle. Venetoclax will be administered days 1-3, with the following schema: 100 mg on day 1, 200 mg on day 2, 400 mg on day 3, and it will be continued at 400mg thereafter until day 28, the completion of cycle 1.
  • Experimental: Cohort 2 CC-486 300 mg
    CC-486 300 mg will be administered orally on days 1-14 of a 28-day cycle. Venetoclax will be administered days 1-3, with the following schema: 100 mg on day 1, 200 mg on day 2, 400 mg on day 3, and it will be continued at 400mg thereafter until day 28, the completion of cycle 1.
  • Experimental: Dose Expansion Cohort
    CC-486 MTD will be determine following the completion of Cohort 1 and Cohort 2 with venetoclax at 400 mg/day PI regimen for 28 days.

Primary Outcome Measure

Determine the maximum tolerated dose of CC-486 in combination with venetoclax [ Time Frame: 7 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
CU Anschutz Medical CampusAuroraColorado80045
Derek Schatz
[email protected]
Constance Brecl
[email protected]
3035078221
University of Colorado HospitalAuroraColorado80045
Derek Schatz
[email protected]
Constance Brecl
[email protected]
Daniel Pollyea, MD (PRINCIPAL_INVESTIGATOR)
Peter Forsberg, MD (SUB_INVESTIGATOR)
Jonathan Gutman, MD (SUB_INVESTIGATOR)
Brad Haverkos, MD (SUB_INVESTIGATOR)
Manali Kamdar, MD (SUB_INVESTIGATOR)
Mathew Angelos, MD (SUB_INVESTIGATOR)
Daniel Sherbenou, MD (SUB_INVESTIGATOR)
Clay Smith, MD (SUB_INVESTIGATOR)
Jagar Jasem, MD (SUB_INVESTIGATOR)
Maria Amaya, MD PhD (SUB_INVESTIGATOR)
Christine McMahon, MD (SUB_INVESTIGATOR)
Marc Schwartz, MD (SUB_INVESTIGATOR)
Steven Bair, MD (SUB_INVESTIGATOR)
Jorge Urrea, MD (SUB_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
CU Anschutz Medical Campus· Aurora, COUniversity of Colorado Hospital· Aurora, CO

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