Clinical trial NCT05506332: Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed/Refractory Acute Myeloid Leukemia
Official title: ABT-199 (Venetoclax) and Purine Analogues as Novel Oral Drug Combination for Treatment of Relapsed/Refractory Acute Myeloid Leukemia: the ApoAML Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Acute Myeloid Leukemia, in Relapse
Acute Myeloid Leukemia Refractory
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical response
timeFrame: at 2 months
measure: Clinical response
timeFrame: at 6 months
measure: Clinical response
timeFrame: at 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
city: Roeselare
country: Belgium
facility: AZ Delta
state: West Vlaanderen
Study officials:
affiliation: University Hospital, Antwerp
name: Sébastien Anguille, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: