Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory
Conditions
Brief summary
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.
Detailed description
Non-commercial, open-label interventional phase Ib study. The aim of the study is to assess the effectivity of the combination of venetoclax and 6-mercaptopurine in patients with relapsed or refractory AML.
Interventions
DRUGVenetoclax
Venetoclax and 6-mercaptopurine
DRUG6-mercaptopurine
Venetoclax and 6-mercaptopurine
Sponsors
University Hospital, Antwerp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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-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 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/µl (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response | at 2 months | Objective response rate |
Countries
Belgium
Contacts
Primary ContactSébastien Anguille, Prof. Dr.
Outcome results
None listed