RecruitingPhase 1NCT05506332

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

ABT-199 (Venetoclax) and Purine Analogues as Novel Oral Drug Combination for Treatment of Relapsed/Refractory Acute Myeloid Leukemia: the ApoAML Trial

Sponsor

University Hospital, Antwerp

Enrollment

10 participants

Start Date

Jul 15, 2022

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia, in Relapse Acute Myeloid Leukemia, Refractory

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria9

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