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Hydrochloroquinine & Decitabine With Venetoclax in AML
Sponsor: Rutgers, The State University of New Jersey
Summary
Phase I: Primary Objective: \- Determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of the o-Dec, ven, and HCQ Secondary Objectives: * Characterize the safety profile of the triplet * Estimate the efficacy of the combination to induce remission
Official title: A Phase I Study of Autophagy Inhibition With Hydroxychloroquine and Oral Decitabine With Venetoclax After Hypomethylating Agent and Venetoclax Failure in Acute Myeloid Leukemia.
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2026-09
Completion Date
2028-06
Last Updated
2026-09-10
Healthy Volunteers
No
Conditions
Interventions
Hydroxychloroquine
Hydroxychloroquine will be administered orally as part of a combination regimen with Decitabine (oral decitabine-cedazuridine) and Venetoclax. In the Phase I portion, hydroxychloroquine will be given at escalating dose levels using a BOIN design to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D).
Venetoclax
Venetoclax is a potent, selective, orally bioavailable small-molecule inhibitor of the anti-apoptotic protein B-cell lymphoma-2 (BCL-2). It promotes apoptosis of malignant cells that are dependent on BCL-2 for survival. Venetoclax will be supplied through the study participants' commercial pharmacy. Venetoclax is supplied as film-coated oral tablets containing 10 mg, 50 mg, or 100 mg of active drug. Tablets are intended for oral administration only. No reconstitution or dilution is required
Oral Decitabine/cedazuridine
Oral decitabine/cedazuridine is a fixed-dose combination of decitabine, a hypomethylating agent (DNA methyltransferase inhibitor), and cedazuridine, a cytidine deaminase inhibitor that increases oral bioavailability of decitabine by preventing its rapid degradation in the gut and liver. Each tablet contains 35 mg decitabine and 100 mg cedazuridine. The combination provides systemic exposure comparable to that of IV decitabine 20 mg/m² given over 5 days. Oral decitabine/cedazuridine will be obtained through the study participant's commercial pharmacy.