RECRUITING

Pilot Study of Reduced Venetoclax Exposure

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

A pilot single-arm clinical trial is proposed to assess the primary objective: the tolerability of 14-day Venetoclax cycles in acute myeloid leukemia (AML) patients who have achieved remission and are ineligible for intensive treatment. Participants in the study will transition to a maintenance regimen that reduces the Venetoclax dosage to 14 days per cycle while continuing the hypomethylating agent (HMA) used during induction. Treatment cycles will occur every 28 days. Participants will continue treatment on study until experiencing a grade 4 cytopenic event lasting more than 7 days, an adverse event requiring regimen modification, relapse, or death. Our primary hypothesis posits that AML patients receiving Venetoclax for 14 days per cycle will exhibit improved treatment tolerability with a reduced rate of grade 4 cytopenia compared to historical data from the VIALE A trial.

Official Title

A Pilot Study of Reduced Venetoclax Exposure in Patients With Acute Myeloid Leukemia in Complete Remission

Quick Facts

Study Start:2024-10-07
Study Completion:2028-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07163793

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Stated willingness to comply with all study procedures and availability for the duration of the study
  2. 2. Ability to take oral medication and be willing to adhere to the study regimen
  3. 3. Diagnosed by current WHO or ICC criteria with Acute Myeloid Leukemia and treated for initial induction therapy with one of two regimens:
  4. 1. 5-Azacitidine administered subcutaneously at a dose of 75mg/m2/day X 7 days in combination with VEN (21-28 days/cycle)
  5. 2. Decitabine administered intravenously at a dose of 20mg/m2/day administered in combination with VEN (21-28 days/cycle)
  6. 4. Achieving morphological CR/CRi by bone marrow biopsy with \<5% blasts within 3 cycles. See Appendix 2 for definitions.
  7. 5. Consent to be obtained within 10 days (+/- 3 days) of bone marrow biopsy report showing morphological remission. C1D1 of trial to be initiated within 10 days (+/- 7 days) of bone marrow biopsy report showing morphological remission.
  8. 6. ECOG 0-3
  9. 7. Intensive treatment ineligible; transplant ineligible or refusal of transplant
  10. 8. Patient must be able to understand and sign informed consent and additional study documents
  11. 9. On C1D1 of trial, patient must have count recovery with ANC \>1000, platelets \> 50, Hemoglobin \> 7.7 and without transfusion support for 7 days.
  12. 10. No growth factor (G-CSF) use in 14 days prior to C1 D1 of trial.
  1. 1. Treatment with another investigational drug
  2. 2. Use of growth factor (G-CSF) within the last 14 days prior to C1D1 of trial treatment.
  3. 3. On concomitant targeted therapy such as FLT3 inhibitor or IDH1/2 inhibitor.
  4. 4. Subject has received treatment prior to induction with the following:
  5. 5. Subject has:

Contacts and Locations

Study Contact

Josephine Vernet, RN
CONTACT
(516) 734-8896
JVernet@northwell.edu
Lalta Dhanantwari, MBA
CONTACT
ldhanantwari@northwell.edu

Principal Investigator

David Chitty, DO
PRINCIPAL_INVESTIGATOR
Northwell Health

Study Locations (Sites)

Zuckerberg Cancer Center
New Hyde Park, New York, 11042
United States

Collaborators and Investigators

Sponsor: Northwell Health

  • David Chitty, DO, PRINCIPAL_INVESTIGATOR, Northwell Health

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 Date2024-10-07
Study Completion Date2028-10

Study Record Updates

Study Start Date2024-10-07
Study Completion Date2028-10

Terms related to this study

Keywords Provided by Researchers

  • AML

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia in Remission