Pilot Study of Reduced Venetoclax Exposure for AML in Remission
This study is looking at a new way to give Venetoclax, a targeted therapy, to people with Acute Myeloid Leukemia (AML) who are in remission. The goal is to see if giving Venetoclax for 14 days instead of longer, combined with Azacitidine or Decitabine, is easier to tolerate. You could be eligible if you are 18 or older, have AML in remission, and are able to take oral medications. The study will measure how well people tolerate this reduced Venetoclax schedule over 12 months. The study is currently unclear on its recruitment status and plans to enroll 41 participants.
- Study design
- This is a pilot single-arm study, meaning all participants will receive the same treatment. It plans to enroll 41 participants.
- What's involved
- Participants will take Azacitidine or Decitabine along with Venetoclax for 14 days, with treatment cycles every 28 days. You will continue treatment until certain events occur, such as side effects or relapse.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, Venetoclax Tolerability Rate, is measured at 12 months. This suggests follow-up will occur for at least this duration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pilot Study of Reduced Venetoclax Exposure
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Boiclair Stephanie, MD · PRINCIPAL_INVESTIGATOR · Northwell Health
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Venetoclax Tolerability Rate12 months
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.