Actively Recruiting
Pilot Study of Reduced Venetoclax Exposure
Led by Northwell Health · Updated on 2025-11-20
41
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pilot Study of Reduced Venetoclax Exposure
CONDITIONS
Official Title
Pilot Study of Reduced Venetoclax Exposure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to comply with all study procedures and be available for the duration of the study
- Ability to take oral medication and adhere to the study regimen
- Diagnosed with Acute Myeloid Leukemia by current WHO or ICC criteria and treated with one of these induction regimens: 5-Azacitidine subcutaneously 75mg/m2/day for 7 days with Venetoclax, or Decitabine intravenously 20mg/m2/day with Venetoclax
- Achieved morphological complete remission or complete remission with incomplete blood count recovery by bone marrow biopsy showing less than 5% blasts within 3 cycles
- Consent obtained within 10 days (±3 days) of bone marrow biopsy showing remission; trial treatment started within 10 days (±7 days) of remission biopsy
- ECOG performance status of 0 to 3
- Ineligible for intensive treatment; ineligible for or refusing transplant
- Able to understand and sign informed consent and study documents
- On first day of trial, blood counts recovered with ANC over 1000, platelets over 50, hemoglobin over 7.7, and no transfusion support for 7 days
- No growth factor (G-CSF) use within 14 days before first day of trial treatment
You will not qualify if you...
- Treatment with another investigational drug
- Use of growth factor (G-CSF) within 14 days before first day of trial treatment
- Receiving targeted therapy such as FLT3 inhibitor or IDH1/2 inhibitor
- Prior treatment before induction with hypomethylating agents or BCL-2 inhibitors except induction
- Prior CAR-T cell therapy
- Experimental or investigational drug therapy within 14 days before study entry
- Diagnosis of acute promyelocytic leukemia (APL) with t(15;17)
- Presence of t(9;22) chromosome due to possible need for tyrosine kinase therapy
- Known active central nervous system involvement with AML
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zuckerberg Cancer Center
New Hyde Park, New York, United States, 11042
Actively Recruiting
Research Team
H
Heme Referral Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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