Hydrochloroquinine & Decitabine With Venetoclax in AML

ConditionAcute Myeloid Leukemia

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-99

SponsorRutgers, The State University of New Jersey

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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).
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
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.

Treatment groups

18 Participants

are divided into 1 treatment group

Group A: Hydroxychloroquine + Oral Decitabine/cedurazidine+ Venetoclax Combination TherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

Phase I - Primary Endpoint

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

Time frame

8 to 12 months

Secondary outcomes

Phase I - Secondary endpoints

Overall response rate (ORR) = CR + CRi + CRh Event-free survival (EFS) from the start of therapy to failure (no CR by week 12), relapse, or death.

Time frame

8 to 12 Months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rutgers, The State University of New Jersey

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: