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

Acute Myeloid Leukemia, in Relapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05506332
• Other study ID #: 2282
• Secondary ID: 2021-006473-35
• Status: Recruiting
• Phase: Phase 1
• Start date: July 15, 2022
• Est. completion date: December 2026

Study information

• Verified date: August 2022
• Source: University Hospital, Antwerp
• Contact: Sébastien Anguille, Prof. Dr.
• Phone: 0032 3 821 3356
• Email: studies.hematologie[@]uza.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia Refractory
• Acute Myeloid Leukemia, in Relapse
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Venetoclax
Venetoclax and 6-mercaptopurine
• 6-mercaptopurine
Venetoclax and 6-mercaptopurine

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp
Belgium	AZ Delta	Roeselare	West Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response	Objective response rate	at 2 months
Primary	Clinical response	Objective response rate	at 6 months
Primary	Clinical response	Objective response rate	at 2 years