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Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed/Refractory Acute Myeloid Leukemia | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT05506332•University Hospital, Antwerp

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (2)

University Hospital Antwerp

Edegem, Antwerp, Belgium

AZ Delta

Roeselare, West Vlaanderen, Belgium

Key Dates

Start Date

July 15, 2022

Primary Completion Date

December 1, 2024

Completion Date

December 1, 2026

Last Updated

August 18, 2022

Enrollment

ESTIMATED participants

Conditions

Acute Myeloid Leukemia, in RelapseAcute Myeloid Leukemia Refractory

Interventions

Venetoclax

DRUG

6-mercaptopurine

DRUG

Contacts

Sébastien Anguille, Prof. Dr.

CONTACT

0032 3 821 3356 studies.hematologie@uza.be

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 18, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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