Combining venetoclax and 6-mercaptopurine for treating relapsed or 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
This study is testing if combining two drugs, venetoclax and 6-mercaptopurine, can help adults with relapsed or stubborn acute myeloid leukemia feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Edegem, Antwerp and 1 other locations) |
| Trial ID | NCT05506332 on ClinicalTrials.gov |
What this trial studies
This is a non-commercial, open-label phase Ib study designed to evaluate the effectiveness of the combination of venetoclax and 6-mercaptopurine in patients suffering from relapsed or refractory acute myeloid leukemia (AML). The study aims to enroll adult patients who have experienced a relapse after or are refractory to previous chemotherapy treatments. Participants will receive the specified drug combination to assess its impact on their condition. The study will monitor patient responses and side effects to determine the treatment's efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with relapsed or refractory acute myeloid leukemia who have not been previously treated with venetoclax.
Not a fit: Patients with active central nervous system disease or those currently participating in other interventional clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat relapsed or refractory AML.
How similar studies have performed: While this approach is being explored in this specific combination, similar studies have shown promise in treating AML with targeted therapies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edegem, Antwerp and 1 other locations
- University Hospital Antwerp — Edegem, Antwerp, Belgium (Recruiting)
- AZ Delta — Roeselare, West Vlaanderen, Belgium (Not_yet_recruiting)
Study contacts
- Principal investigator: Sébastien Anguille, Prof. Dr. — University Hospital, Antwerp
- Study coordinator: Sébastien Anguille, Prof. Dr.
- Email: studies.hematologie@uza.be
- Phone: 0032 3 821 3356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.