Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed/Refractory Acute Myeloid Leukemia

Sponsor
University Hospital, Antwerp
Study ID
NCT05506332
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia Refractory
  • Acute Myeloid Leukemia, in Relapse

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    Venetoclax and 6-mercaptopurine
  • 6-mercaptopurine — DRUG
    Venetoclax and 6-mercaptopurine

Study Details

Non-commercial, open-label interventional phase Ib study to assess the effectivity of the combination of venetoclax and 6-mercaptopurine in patients with relapsed or refractory AML.

Key Dates

Start date
Jul 15, 2022
Status verified
Aug 2022
Primary completion
Dec 31, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax and 6-mercaptopurine
    Single arm study with venetoclax and 6-mercaptopurine administered in two to six cycles of 28 days. Venetoclax is given at a dosage of 600mg with dose reduction in case of interaction with a moderate or strong CYP3A4 inhibitor. 6-mercaptopurine is given at a dosage of 100mg.

Primary Outcome Measure

Clinical response [ Time Frame: at 2 months ]

Central Contacts

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