Status:
RECRUITING
Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
AbbVie
Dana-Farber Cancer Institute
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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. I...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the safety and tolerability and determine the dose-limiting toxicity and the maximum tolerated dose (MTD) of the combination of daunorubicin \& cytarabine chemothera...
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).
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT05342584
Start Date
May 25 2022
End Date
December 1 2028
Last Update
January 8 2026
Active Locations (1)
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1
Montefiore Einstein Cancer Center and Children's Hospital at Montefiore (CHAM)
The Bronx, New York, United States, 10467