A Pilot Study of Reduced Venetoclax Exposure in Patients With Acute Myeloid Leukemia in Complete Remission
Northwell Health
Summary
Pilot Study of Reduced Venetoclax Exposure
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 adver…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Stated willingness to comply with all study procedures and availability for the duration of the study 2. Ability to take oral medication and be willing to adhere to the study regimen 3. Diagnosed by current WHO or ICC criteria with Acute Myeloid Leukemia and treated for initial induction therapy with one of two regimens: 1. 5-Azacitidine administered subcutaneously at a dose of 75mg/m2/day X 7 days in combination with VEN (21-28 days/cycle) 2. Decitabine administered intravenously at a dose of 20mg/m2/day administered in combination with VEN (21-28 days/cycle) 4.…
Interventions
- DrugAzacitidine
Given Day 1-7 with Venetoclax Day 1-14 every 28 days until off study
- DrugDecitabine
Given Day 1-5 with Venetoclax Day 1-14 every 28 days until off
- DrugVenetoclax
Venetoclax up to 400mg a day on Day 1-14 every 28 days until off in combination with Azacitidine or Decitabine
Location
- Zuckerberg Cancer CenterNew Hyde Park, New York