๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* 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-naรฏve. 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 Criteria:
* Participation in any other interventional clinical trial during the study period
* Active presence (or known history of) central nervous system disease
* 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 HIV, hepatitis B or hepatitis C 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/ยตl (e.g. hydroxyurea).
* 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
* Pregnant or breastfeeding woman
* Active uncontrolled systemic infection
๐
What it tests
- Venetoclax
- 6-mercaptopurine
University Hospital Antwerp
Edegem, Belgium
AZ Delta
Roeselare, Belgium
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.