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

Phase 1

Recruiting

• Conditions: Acute Myeloid Leukemia, in Relapse; Acute Myeloid Leukemia Refractory
• Interventions: Drug: Venetoclax; Drug: 6-mercaptopurine

• Registration Number: NCT05506332
• Lead Sponsor: University Hospital, Antwerp

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.

Study Timeline

• Study Start: 2022-07-15
• Status Verified: 2022-08
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-16
• Last Update Submitted: 2022-08-16
• Study First Posted: 2022-08-18
• Last Update Posted: 2022-08-18
• Primary Completion: 2024-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venetoclax and 6-mercaptopurine	Venetoclax	Single arm study with venetoclax and 6-mercaptopurine administered in two to six cycles of 28 days. Venetoclax is given at a dosage of 600mg with dose reduction in case of interaction with a moderate or strong CYP3A4 inhibitor. 6-mercaptopurine is given at a dosage of 100mg.
Venetoclax and 6-mercaptopurine	6-mercaptopurine	Single arm study with venetoclax and 6-mercaptopurine administered in two to six cycles of 28 days. Venetoclax is given at a dosage of 600mg with dose reduction in case of interaction with a moderate or strong CYP3A4 inhibitor. 6-mercaptopurine is given at a dosage of 100mg.

Primary Outcome Measures

Name	Time	Method
Clinical response	at 2 years	Objective response rate

Trial Locations

Locations (2)

University Hospital Antwerp; 🇧🇪 Edegem, Antwerp, Belgium

AZ Delta; 🇧🇪 Roeselare, West Vlaanderen, Belgium