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RECRUITING
NCT05342584
PHASE1

Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS

Sponsor: Montefiore Medical Center

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

99

Start Date

2022-05-25

Completion Date

2028-12

Last Updated

2026-01-08

Healthy Volunteers

No

Interventions

DRUG

Venetoclax Oral Tablet

Given PO

DRUG

Daunorubicin

Given IV

DRUG

Cytarabine

Given IV

Locations (1)

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

The Bronx, New York, United States