Pilot Study of Reduced Venetoclax Exposure

Part of paid clinical trials in New Hyde Park, New York.

Sponsor
Northwell Health
Study ID
NCT07163793
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia in Remission

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    Given Day 1-7 with Venetoclax Day 1-14 every 28 days until off study
  • Decitabine — DRUG
    Given Day 1-5 with Venetoclax Day 1-14 every 28 days until off
  • Venetoclax — DRUG
    Venetoclax up to 400mg a day on Day 1-14 every 28 days until off in combination with Azacitidine or Decitabine

Study Details

Pilot Study of Reduced Venetoclax Exposure

Key Dates

Start date
Oct 7, 2024
Status verified
Nov 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2028

Study Design

Enrollment
41 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Azacytadine + Venetoclax
  • Active Comparator: Decitabine + Venetoclax

Primary Outcome Measure

Venetoclax Tolerability Rate [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Zuckerberg Cancer CenterNew Hyde ParkNew York11042
Heme Referral Team
[email protected]
516-734-8900
Stephanie Boisclaire, MD
[email protected]
516-734-8900

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Zuckerberg Cancer Center· New Hyde Park, NY

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