Combining venetoclax and 6-mercaptopurine for treating relapsed or refractory acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining cytokine-induced memory-like natural killer cells with atezolizumab for relapsed or refractory AML

  This trial will test whether giving cytokine-induced memory-like natural killer cells together with atezolizumab is safe and might help adults with relapsed or refractory acute myeloid leukemia.

  Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07011004

• Treatment with ARD103 CAR-T therapy for patients with relapsed or refractory AML or MDS

  This study is testing a new CAR-T therapy called ARD103 to see if it can help people with relapsed or hard-to-treat acute myeloid leukemia or myelodysplastic syndrome.

  Recruiting at 3 sites Phase 1/2 ARCE Therapeutics, Inc. · Charlotte, North Carolina and 2 other locations · NCT06680752

• Framework for managing relapsed or refractory acute myeloid leukemia

  This study is trying to see how well new personalized treatments work for people in Europe with relapsed or refractory acute myeloid leukemia to help improve their care.

  Recruiting at 40 sites Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Aachen and 40 other locations · NCT06459024

• Investigating APL-4098 with Azacitidine for treating relapsed or refractory AML and high-risk MDS

  This study is testing a new treatment called APL-4098, alone and with azacitidine, to see if it can help people with relapsed or hard-to-treat acute myeloid leukemia and high-risk myelodysplastic syndrome.

  Recruiting at 8 sites Phase 1 Apollo Therapeutics Ltd · Clayton, Victoria and 8 other locations · NCT06372717

• Using off-the-shelf CAR-NK cells to treat relapsed or refractory acute myeloid leukemia

  This study is testing a new treatment using specially modified immune cells to see if they can help people with relapsed or hard-to-treat acute myeloid leukemia feel better.

  Recruiting Early Phase 1 Peking University People's Hospital · Beijing, Beijing Municipality · NCT06201247

• Using CAR-T cell therapy targeting Tim-3 and CD123 for treating relapsed acute myeloid leukemia

  This study is testing a new CAR-T cell therapy that targets specific markers in people aged 18-70 with relapsed acute myeloid leukemia to see if it can safely improve their treatment outcomes.

  Recruiting Phase 1/2 Xuzhou Medical University · Xuzhou, Jiangsu · NCT06125652

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.