RECRUITING

Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-05-25
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05342584

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Patients ≥ 18 to ≤ 75 years.
  3. * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
  4. * Adequate renal function including creatinine clearance \> 30 mL/min based on the Cockcroft Gault equation.
  5. * 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
  6. * Ability to understand and provide signed informed consent
  7. * 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.
  1. * Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (FAB class M3-AML)
  2. * Subject has known active CNS involvement with AML
  3. * 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
  4. * 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
  5. * Patients with uncontrolled infection with human immunodeficiency virus (HIV) or active Hepatitis B or C
  6. * Patients with known dysphagia, short-gut syndrome, or other conditions that would affect the ingestion or gastrointestinal absorption of drugs administered orally.
  7. * Subject has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study.
  8. * Subject has a white blood cell count \> 25 x 10⁹/L. (Note: Hydroxyurea and/or cytarabine (1 or 2 doses; up to 2 is permitted to meet this criterion.)
  9. * 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).

Contacts and Locations

Study Contact

Ioannis Mantzaris, MD
CONTACT
718-920-4826
imantzar@montefiore.org

Principal Investigator

Ioannis Mantzaris, MD
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center

Study Locations (Sites)

Montefiore Einstein Cancer Center
Bronx, New York, 10467
United States

Collaborators and Investigators

Sponsor: Ioannis Mantzaris

  • Ioannis Mantzaris, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-25
Study Completion Date2028-12

Study Record Updates

Study Start Date2022-05-25
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • AML
  • MDS
  • Venetoclax
  • Ven
  • 7+3
  • daunorubicin and cytarabine
  • daunorubicin
  • cytarabine

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes