Back to search results

Venetoclax with Chemotherapy for AML and Advanced MDS

This study is testing a combination of Venetoclax (an oral tablet) with intensive chemotherapy (Daunorubicin and Cytarabine, given intravenously) for adults with newly diagnosed Acute Myeloid Leukemia (AML) or advanced Myelodysplastic Syndromes (MDS). The main goal is to find the safest and most effective dose of this drug combination. Researchers will closely watch for any side effects (adverse events) and how well the treatment works. You may be eligible if you are between 18 and 75 years old and have a new diagnosis of AML, or certain types of high-risk MDS. The study aims to enroll 99 participants.

Study design
This is an open-label study, meaning you and your doctors will know what treatment you are receiving. It involves a dose-finding phase followed by an expansion phase to further evaluate the treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to 6 years to monitor for side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05342584

Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS

Recruiting
PHASE1Ages 18–75InterventionalTreatment
Montefiore Medical Center
~99 participants
Updated 2026-01-08 on ClinicalTrials.gov
What's tested:Venetoclax Oral TabletDaunorubicinCytarabine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency and Severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured over Through study completion, up to 6 years
+7 more outcomes measured

Conditions

Acute Myeloid Leukemia
Myelodysplastic Syndromes

Explore related trials

Acute Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic Syndrome

NCT05342584

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Montefiore Einstein Cancer Center and Children's Hospital at Montefiore (CHAM)

    The Bronx, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ioannis Mantzaris, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

Ioannis Mantzaris, MD
[email protected]
718-920-4826
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.

Exclusion

Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (FAB class M3-AML)
Subject has known active CNS involvement with AML
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
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.
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.)
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).

What this trial measures

  • Frequency and Severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs)Through study completion, up to 6 years

    The number and percentage of patients with SAEs and AEs, including AEs leading to dose modifications or discontinuations, will be summarized.

  • Frequency and Severity of AEs and SAEs by Age GroupThrough study completion, up to 6 years

    The number and percentage of patients with SAEs and AEs, including AEs leading to dose modifications or discontinuations, will be summarized by age group.

  • Frequency and Severity of AEs and SAEs by Dose LevelThrough study completion, up to 6 years

    The number and percentage of patients with SAEs and AEs, including AEs leading to dose modifications or discontinuations, will be summarized by dose level.

  • Rate of Non-Hematologic Dose Limiting Toxicities (DLTs)Up to 28 days during induction and 1st consolidation cycle

    The rate of non-hematologic DLTs will be monitored. Non-hematologic DLTs will be defined as any Grade 3 or higher non-hematologic events occurring during the first cycle (i.e., the first 28 days) that are at least possibly attributable to Venetoclax unless the event is clearly due to extraneous causes or disease progression, confirmed Hy's law case, with the exceptions outlined in Section 4.5.1 of the study protocol. The number/percentage of patients non-hematologic DLTs will be summarized. 90% Confidence Intervals will be estimated using the Clopper-Pearson method with all available data at the Maximum Tolerated Dose (MTD) and, if relevant, for the dose level below.

  • Rate of Hematologic Dose Limiting Toxicities (DLTs)Up to 42 days during induction and 1st consolidation cycle

    The rate of hematologic DLTs will be monitored. Hematologic DLT is defined as Grade ≥ 3 neutropenia and/or thrombocytopenia with no greater than 5% marrow blasts lasting for 6 weeks or more after the start of a course unless the delay in count recovery is due to another identifiable factor, such as documented myelosuppressive infection. Anemia will not be considered for the definition of DLT. The number/percentage of patients with hematologic DLTs will be summarized. 90% Confidence Intervals will be estimated using the Clopper-Pearson method with all available data at the MTD and, if relevant, for the dose level below.

  • The Number/Percentage of Patients with Dose ModificationsDuring the 3 days of chemotherapy administration

    The number/percentage of patients with dose modifications, as prescribed in the protocol for the 400mg and 200mg dosage, will be summarized. It should be noted that the only relevant dose modifications apply to consolidation cycles with intermediate dose cytarabine and specifically the older group cohort.

  • Maximum tolerated dose of Venetoclax in combination with Daunorubicin and CytarabineDuring induction phase, up to 14 days

    To determine a safe and tolerable dose of Venetoclax in combination with Daunorubicin and Cytarabine during the induction phase.

  • Maximum tolerated dose of Venetoclax in combination with high dose CytarabineDuring consolidation phase, up to 7 days

    To determine a safe and tolerable dose of Venetoclax in combination high dose of Cytarabine during the consolidation phase.