Actively Recruiting
CC-486 and Venetoclax for Acute Myeloid Leukemia
Led by University of Colorado, Denver · Updated on 2026-01-15
35
Participants Needed
2
Research Sites
323 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
CC-486 and Venetoclax for Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of non-APL AML confirmed by WHO criteria
- Have received at least one line of therapy for relapsed/refractory cohorts or are newly diagnosed with no prior therapy
- Newly diagnosed patients must be unlikely to tolerate standard intensive chemotherapy due to age (≥75 years) or comorbidities
- ECOG performance status 0 to 3 if under 75 years, or 0 to 2 if 75 years or older
- Patients eligible for stem cell transplant may participate
- Projected life expectancy of at least 12 weeks
- Adequate kidney function with creatinine clearance ≥ 30 mL/min
- Adequate liver function with AST and ALT ≤ 3 times upper limit of normal and bilirubin ≤ 1.5 times upper limit of normal unless due to Gilbert's syndrome
- Non-sterile male subjects must use contraception and agree to avoid sperm donation during and up to 90 days after study drug
- Female subjects must be postmenopausal, surgically sterile, or use contraception if of childbearing potential
- Signed informed consent obtained
- Avoid consumption of grapefruit, Seville oranges, star fruit 3 days before and during study
You will not qualify if you...
- Known active central nervous system involvement from AML
- Known positive HIV infection
- Known positive hepatitis B or C infection unless viral load is undetectable
- Significant active cardiac disease within the past 6 months including advanced heart failure, unstable angina, or recent heart attack
- History of serious renal, neurologic, psychiatric, endocrine, metabolic, immune, liver, cardiovascular, or bleeding disorders unrelated to leukemia
- Malabsorption syndrome or gastrointestinal disorders preventing oral medication absorption
- Uncontrolled systemic infections requiring therapy
- History of other cancers except certain treated skin or localized cancers
- White blood cell count greater than 25 x 10^9/L (hydroxyurea or apheresis allowed to meet this)
- Candidates for intensive induction therapy who agree to receive it
- Pregnant or breastfeeding females
- Known or suspected allergy to azacitidine or mannitol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
CU Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
D
Derek Schatz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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