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.

NCT07163793

Pilot Study of Reduced Venetoclax Exposure

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Northwell Health
~41 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:AzacitidineDecitabineVenetoclax

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Venetoclax Tolerability Rate
Measured over 12 months
Acute Myeloid Leukemia in Remission
1 sites across 1 states
New York1
  • Boiclair Stephanie, MD · PRINCIPAL_INVESTIGATOR · Northwell Health

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • 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.