RecruitingPhase 1NCT05287568

CC-486 and Venetoclax for Acute Myeloid Leukemia


Sponsor

University of Colorado, Denver

Enrollment

35 participants

Start Date

Dec 19, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — CC-486 (an oral chemotherapy pill) and venetoclax — in people with a type of blood cancer called acute myeloid leukemia (AML). It includes both newly diagnosed patients who cannot tolerate standard intensive chemotherapy and patients whose AML has come back or stopped responding to treatment. **You may be eligible if...** - You have been diagnosed with AML (excluding a subtype called APL) - You have had at least one prior treatment (for relapsed/refractory patients), or you are newly diagnosed and cannot tolerate intensive chemotherapy - You are newly diagnosed and meet at least one of: age 75 or older; age under 75 with heart failure, poor heart function (EF ≤50%), significant lung disease, or reduced kidney function - You are willing to use contraception if applicable **You may NOT be eligible if...** - You have the APL subtype of AML - You are newly diagnosed and able to tolerate standard intensive chemotherapy - You have very poor kidney function (creatinine clearance under 30 mL/min) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax

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.

DRUGCC-486

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


Locations(2)

CU Anschutz Medical Campus

Aurora, Colorado, United States

University of Colorado Hospital

Aurora, Colorado, United States

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NCT05287568


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