Tests venetoclax with 6-mercaptopurine in adults with returned or non-responding acute myeloid leukemia
Tests venetoclax and 6-mercaptopurine together in adults with relapsed or refractory acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed/Refractory Acute Myeloid Leukemia
Key facts
- Where
- Edegem and Roeselare, BelgiumSee the 2 sites
- Phase
- Phase 1
Where in Belgium
- Antwerp University HospitalEdegem, BelgiumNot yet recruiting
- Algemeen Ziekenhuis DeltaRoeselare, BelgiumNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Antwerp
- Trial code
- NCT05506332EU 2024-510717-15-00
- Record updated
- 18 August 2022
- Original description
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.Read full original descriptionShow less
ABT-199 (Venetoclax) and Purine Analogues as Novel Oral Drug Combination for Treatment of Relapsed/Refractory Acute Myeloid Leukemia: the ApoAML Trial
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.
Inclusion: Relapsed or refractory AML; Relapsed after or refractory to at least one cycle of intensive chemotherapy (combination of ara-c/anthracyclin) or four cycles of HMA (hypomethylating agents); Adult AML aged >/= 18 years; WHO performance status: grade 0-2 at the time of enrollment; ABT-199 (venetoclax) and PA-naïve. Patient may be prior exposed but not refractory to venetoclax. In case of previous therapy with venetoclax inclusion is only possible after discussion with the PI.
Exclusion: History or concomitant presence of any other malignancy, except for non-melanoma skin cancer, carcinoma in situ of the cervix, any other effectively treated malignancy that has been in remission for >5 years or that is highly likely to be cured at the time of enrollment; Active presence (or known history of) central nervous system disease; Active HIV, hepatitis B or hepatitis C infection; Medical conditions requiring chronic therapy of moderate or strong CYP3A4 inducers without alternative; Patients with known hypersensitivity to the active substance or to any of the excipients; Active uncontrolled systemic infection; Use of any antitumoral agent within less than 5 times the half-life of the agent prior to the screening bone marrow examination. After the screening bone marrow examination, the use of cytoreductive treatment prior to the initiation of venetoclax is permitted in order to lower the WBC-count to <25 000/µl (e.g. hydroxyurea); Participation in any other interventional clinical trial during the study period; Pregnant or breastfeeding woman.