Actively Recruiting
Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed/Refractory Acute Myeloid Leukemia
Led by University Hospital, Antwerp · Updated on 2022-08-18
10
Participants Needed
2
Research Sites
228 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed/Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Relapsed or refractory acute myeloid leukemia (AML)
- Relapsed after or refractory to at least one cycle of intensive chemotherapy or four cycles of hypomethylating agents
- Adults aged 18 years or older
- WHO performance status grade 0 to 2 at enrollment
- Nafve to ABT-199 (venetoclax) and purine analogues, or prior exposure without refractory disease (inclusion after PI discussion if previously treated with venetoclax)
You will not qualify if you...
- Participation in any other interventional clinical trial during the study period
- Active or history of central nervous system disease
- History or presence of other malignancies except certain treated cancers in remission for over 5 years
- Active HIV, hepatitis B, or hepatitis C infection
- Use of antitumoral agents within less than five times their half-life before screening bone marrow exam
- Medical conditions requiring chronic use of moderate or strong CYP3A4 inducers without alternatives
- Known hypersensitivity to study drugs or excipients
- Pregnant or breastfeeding women
- Active uncontrolled systemic infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
2
AZ Delta
Roeselare, West Vlaanderen, Belgium, 8800
Not Yet Recruiting
Research Team
S
Sébastien Anguille, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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