Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed/Refractory Acute Myeloid Leukemia
NCT ID: NCT05506332
Last Updated: 2022-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2022-07-15
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Venetoclax and 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.
Venetoclax
Venetoclax and 6-mercaptopurine
6-mercaptopurine
Venetoclax and 6-mercaptopurine
Interventions
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Venetoclax
Venetoclax and 6-mercaptopurine
6-mercaptopurine
Venetoclax and 6-mercaptopurine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Antwerp
OTHER
Responsible Party
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Principal Investigators
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Sébastien Anguille, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Antwerp
Locations
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University Hospital Antwerp
Edegem, Antwerp, Belgium
AZ Delta
Roeselare, West Vlaanderen, Belgium
Countries
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Central Contacts
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Facility Contacts
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Sébastien Anguille, Prof. Dr.
Role: primary
Dries Deeren, Dr.
Role: primary
Other Identifiers
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2021-006473-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2282
Identifier Type: -
Identifier Source: org_study_id
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