Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed/Refractory Acute Myeloid Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Venetoclax, 6-mercaptopurine.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ABT-199 (Venetoclax) and Purine Analogues as Novel Oral Drug Combination for Treatment of Relapsed/Refractory Acute Myeloid Leukemia: the ApoAML Trial
Overview
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.
Interventions
- Drug Venetoclax
Venetoclax and 6-mercaptopurine - Drug 6-mercaptopurine
Venetoclax and 6-mercaptopurine
Primary outcome measures
- Clinical response [Time frame: at 2 months]
- Clinical response [Time frame: at 6 months]
- Clinical response [Time frame: at 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 2 centers
- University Hospital Antwerp — Edegem
- AZ Delta — Roeselare
Identifiers
NCT: NCT05506332 · 2282 · 2021-006473-35