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Not Yet Recruiting
NCT07814339
Hydrochloroquinine & Decitabine With Venetoclax in AML
Conditions: Acute Myeloid Leukemia
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 18
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
Eligibility Criteria
Inclusion criteria
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 (\
Source: ClinicalTrials.gov (NCT07814339). StuddyBuddy aggregates publicly available trial information.
