Hydrochloroquinine & Decitabine With Venetoclax in AML

NCT07814339 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 022601
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Phase I - Primary Endpoint

  Incidence of dose-limiting toxicities (DLTs) during Cycle 1, nonhematologic toxicity, or prolonged cytopenia not attributable to AML

  8 to 12 months

Secondary Outcomes (1)

• Phase I - Secondary endpoints

  8 to 12 Months

Study Arms (1)

Hydroxychloroquine + Oral Decitabine/cedurazidine+ Venetoclax Combination Therapy

EXPERIMENTAL

Participants in this arm will receive a combination of Hydroxychloroquine (HCQ), oral Decitabine/cedurazidine, and Venetoclax, The therapy is administered in cycles according to the protocol.

Drug: Hydroxychloroquine; Drug: Venetoclax; Drug: Oral Decitabine/cedazuridine

Interventions

Venetoclax DRUG

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

Hydroxychloroquine + Oral Decitabine/cedurazidine+ Venetoclax Combination Therapy

Hydroxychloroquine DRUG

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).

Hydroxychloroquine + Oral Decitabine/cedurazidine+ Venetoclax Combination Therapy

Oral Decitabine/cedazuridine DRUG

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.

Hydroxychloroquine + Oral Decitabine/cedurazidine+ Venetoclax Combination Therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Confirmed acute myeloid leukemia per 2022 WHO (≥20 % blasts or genetically-defined AML) 2. Age ≥ 18 years on the date of consent Disease status 3. Phase I: Relapsed/refractory (R/R) or newly-diagnosed, overy high risk defined as p53 mutation or secondary AML after MPN or chemotherapy/radiation exposure 4. An ECOG performance status of 0-2 5. Acceptable Organ function within 14 days of cycle 1 day 1 6. AST/ALT ≤ 3× ULN; total bilirubin ≤ 1.5× ULN (unless Gilbert's) 7. Creatinine clearance \> 60 mL/min (Cockcroft-Gault) 8. Subjects must have a baseline QTc interval of less than 450 milliseconds (\<450 ms) White blood cells \< 25 × 10⁹/L before first dose of hypomethylating agent - debulking with hydroxyurea/leukapheresis or up to 6 doses of cytarabine 100mg-200mg if needed is acceptable.
• \. HIV, HBV, and HCV patients are eligible if viral load is undetectable on stable therapy Wash-out from prior therapies should be ≥14 days from the last cytotoxic or targeted agent, and recovery to ≤Grade 1 non-hematologic toxicity 10. Reproductive precautions 11.Negative serum β-hCG for WOCBP; agreement to use highly effective contraception during treatment and ≥ 90 days after last dose Signed written informed consent and willingness to comply with study procedures

You may not qualify if:

• Leukemia subtype - Acute promyelocytic leukemia (APL, PML-RARA)
• CNS leukemia not cleared (\<5 WBC/µL \& no blasts), or symptomatic CNS involvement
• Recent or uncontrolled transplant-related complications Allogeneic HSCT ≤ 90 days before Day 1 Active grade ≥ 2 GVHD or systemic immunosuppression \>10 mg/day prednisone-equivalent
• Concurrent malignancies requiring active therapy. Any adequately treated in-situ cancers or those not expected to interfere with endpoints are allowed.
• Active, uncontrolled infection (bacterial, viral, or fungal) despite appropriate antimicrobial therapy
• Cardiac risk, NYHA class III/IV heart failure, unstable angina, recent MI (\< 6 months), clinically significant arrhythmia, Concomitant use of QT-prolonging medications that cannot be discontinued, or history of torsades de pointes
• Pregnant or breastfeeding.
• Patients with known G6PD deficiency.
• Investigational drug or major surgery within 28 days.
• Bleeding diathesis/coagulopathy that would preclude required marrow aspirates or lumbar puncture.
• Psychiatric or social condition that, in the investigator's judgment, would impair compliance with protocol-mandated visits/procedures.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Hydroxychloroquine; venetoclax; decitabine and cedazuridine drug combination

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Neil Palmisiano, MD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neil Palmisiano, MD

CONTACT

732-235-2465; wesoloel@cinj.rutgers.edu

Elayne Wesolowsky

CONTACT

wesoloel@cinj.rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Medical Director of the Office of Human Research Services, Rutgers Cancer Institute

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: September 10, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share