Pilot Study of Reduced Venetoclax Exposure
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Given Day 1-7 with Venetoclax Day 1-14 every 28 days until off study
Given Day 1-5 with Venetoclax Day 1-14 every 28 days until off
Venetoclax up to 400mg a day on Day 1-14 every 28 days until off in combination with Azacitidine or Decitabine
Zuckerberg Cancer Center
New Hyde Park, New York, United States
Venetoclax Tolerability Rate
Tolerability rate defined as the proportion of patients who do not experience grade 4 neutropenia (per the CTCAE v5.0) for over 7 continuous days within the first three cycles of maintenance therapy (90 days). Patient will be evaluated on Day 1 of each cycle. Laboratory studies of prior cycle will be reviewed on that day to identify if patient had \>7 continuous days of cytopenia.
Time frame: 12 months
Evaluation of Event-Free Survival (EFS)
EFS: Time from treatment-to-treatment discontinuation, relapse, death of any cause, or lost to follow up (Lost to follow up defined as missing scheduled appointment with no response to 3 phone calls and 1 certified letter).
Time frame: 12 months
Time to Detriment
Time to detriment defined as time to meaningful change in the EORTC-QLQ-C30. A meaningful change is defined as a decrease by at least 10 points from their baseline evaluation The EORTC-QLQ0-C30 will be filled out by patient on Day 1 of every cycle for the first 12 cycles of maintenance therapy.
Time frame: 48 months
Number of pRBC transfusion
Number of pRBC transfusion received while on trial therapy. Number of platelet transfusion received while on trial therapy. Number of transfusions to be described per patient year. Data collected on Day 1 of every cycle.
Time frame: 48 months
Evaluate Number of Hospital Admissions
To be evaluated at time of trial therapy discontinuation or 12 cycles of therapy, whichever occurs first.
Time frame: 12 months
Rate of adverse events/toxicities
dverse events/Toxicities related to treatment. List of adverse events/toxicities expected listed in Section 8.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 48 months
Evaluation of Relapse-Free Survival (RFS)
RFS: Time from treatment initiation to relapse, death, or lost to follow up (Lost to follow up defined as missing scheduled appointment with no response to 3 phone calls and 1 certified letter).
Time frame: 12 months
Evaluation of Overall Survival (OS)
OS: Time to death or lost to follow up (Lost to follow up defined as missing scheduled appointment with no response to 3 phone calls and 1 certified letter)
Time frame: 12 months
Evaluate Number of Days Admitted
To be evaluated at time of trial therapy discontinuation or 12 cycles of therapy, whichever occurs first.
Time frame: 12 months
Evaluate Number of Unanticipated lab appointments
To be evaluated at time of trial therapy discontinuation or 12 cycles of therapy, whichever occurs first.
Time frame: 12 months
Evaluate Number of Unanticipated clinic visits
To be evaluated at time of trial therapy discontinuation or 12 cycles of therapy, whichever occurs first.
Time frame: 12 months