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NCT07814339Not yet recruitingPhase 1

Hydrochloroquinine & Decitabine With Venetoclax in AML

A Phase I Study of Autophagy Inhibition With Hydroxychloroquine and Oral Decitabine With Venetoclax After Hypomethylating Agent and Venetoclax Failure in Acute Myeloid Leukemia.

Source: ClinicalTrials.gov · Last updated 10 Sept 2026

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
18 (estimated)
First submitted
15 Jun 2026
Start date
Sept 2026
Primary completion date
Jun 2028
Lead sponsor
Rutgers, The State University of New Jersey
NCT number
NCT07814339

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 18
  • From Sept 2026 to the primary completion date, Jun 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 1\. 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.
  • 9\. 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
  • Exclusion Criteria
    • 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.

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.