Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07814339
PHASE1

Hydrochloroquinine & Decitabine With Venetoclax in AML

Sponsor: Rutgers, The State University of New Jersey

View on ClinicalTrials.gov

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

Interventions

DRUG

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).

DRUG

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

DRUG

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.