RecruitingPhase 1NCT05342584

Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS

Phase 1B Study of Venetoclax in Combination With Standard Intensive Chemotherapy With Daunorubicin Plus Cytarabine Followed by High-Dose Cytarabine in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia and Advanced Myelodysplastic Syndrome

Sponsor

Montefiore Medical Center

Enrollment

99 participants

Start Date

May 25, 2022

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndromes

Summary

This is a Phase 1b, open-label study evaluating Venetoclax in combination with intensive induction and consolidation chemotherapy in previously untreated, adult patients with acute myeloid leukemia. In Part 1, the dose escalation phase, the safety and tolerability of the combination with Venetoclax at different doses and duration will inform the appropriate dose(s) and regimen(s) for Part 2. In Part 2, the dose expansion phase, a maximum of 28 additional patients will be randomized 1:1 to the MTD determined in Part 1 and the starting dose (assuming the MTD is not the starting dose), to further evaluate the safety and efficacy of the study drug combination.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing venetoclax — a drug that helps cancer cells die — combined with intensive chemotherapy in patients with newly diagnosed AML (acute myeloid leukemia) or advanced MDS (a bone marrow disorder that can turn into leukemia), to see if this combination improves remission rates. **You may be eligible if...** - You are between 18 and 75 years old - You have a new diagnosis of AML, or high-risk MDS (with 10% or more blasts), or proliferative CMML-2 - Prior treatment with hypomethylating agents (like azacitidine or decitabine) may still be eligible at the investigator's discretion - Your ECOG performance status is 2 or less - Your kidney and liver function meet the required levels **You may NOT be eligible if...** - You are outside the age range of 18–75 - You have significant kidney, liver, or heart conditions that don't meet study requirements - You cannot give informed consent 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 Oral Tablet

Given PO

DRUGDaunorubicin

Given IV

DRUGCytarabine

Given IV

Locations(1)

Montefiore Einstein Cancer Center and Children's Hospital at Montefiore (CHAM)

The Bronx, New York, United States

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NCT05342584

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