NCT05342584RecruitingPhase 1

Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS

Phase 1B Study of Venetoclax in Combination With Standard Intensive Chemotherapy With Daunorubicin Plus Cytarabine Followed by High-Dose Cytarabine in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia and Advanced Myelodysplastic Syndrome

Source: ClinicalTrials.gov · Last updated 8 Jan 2026

Brief summary (registry, in English)

This is a Phase 1b, open-label study evaluating Venetoclax in combination with intensive induction and consolidation chemotherapy in previously untreated, adult patients with acute myeloid leukemia. In Part 1, the dose escalation phase, the safety and tolerability of the combination with Venetoclax at different doses and duration will inform the appropriate dose(s) and regimen(s) for Part 2. In Part 2, the dose expansion phase, a maximum of 28 additional patients will be randomized 1:1 to the MTD determined in Part 1 and the starting dose (assuming the MTD is not the starting dose), to further evaluate the safety and efficacy of the study drug combination.

Status (registry): Recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 99 (estimated)
First submitted: 19 Apr 2022
Start date: 25 May 2022
Primary completion date: Dec 2028
Lead sponsor: Montefiore Medical Center
Diseases: Myelodysplastic syndromes, Acute myeloid leukemia
NCT number: NCT05342584

What you commit to

Study type: Interventional · Phase 1
Planned participants: 99
From 25 May 2022 to the primary completion date, Dec 2028
1 site in 1 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.

Other illness

Patients with a history of myocardial infarction within the last 6 months or unstable / uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias
Patients with uncontrolled infection with human immunodeficiency virus (HIV) or active Hepatitis B or C
Patients with known dysphagia, short-gut syndrome, or other conditions that would affect the ingestion or gastrointestinal absorption of drugs administered orally.
Subject has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study.

Lab values

Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF \<45% by echocardiogram or multi-gated acquisition (MUGA) scan
Subject has a white blood cell count \> 25 x 10⁹/L. (Note: Hydroxyurea and/or cytarabine (up to 2 g/m\^2 is permitted to meet this criterion.)

Other

Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (FAB class M3-AML)
Subject has known active CNS involvement with AML
Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception. Appropriate method(s) of contraception include oral or injectable hormonal birth control, IUD, and double barrier methods (for example a condom in combination with a spermicide).

Who the study is looking for

New diagnosis of AML by WHO criteria. Patients with higher risk MDS (R-IPSS\>3.5) and 10% blasts or more, or proliferative (WBC ≥ 13 x 10⁹/L) CMML-2 are also eligible at the discretion of the PI. Patients having received any prior hypomethylating agent with or without BCL2 inhibitor therapy for MDS/AML are also eligible at the discretion of the PI
Patients ≥ 18 to ≤ 75 years.
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
Adequate renal function including creatinine clearance \> 30 mL/min based on the Cockcroft Gault equation.
Adequate hepatic function including total bilirubin \< 1.5x ULN unless increase is due to Gilbert's disease or leukemic involvement, and AST and/or ALT \< 3x ULN unless considered due to leukemic involvement
Ability to understand and provide signed informed consent
Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Montefiore Einstein Cancer Center and Children's Hospital at Montefiore (CHAM) Coordinator of this site? Confirm its status	The Bronx	United States	Recruiting

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