Combining avapritinib, azacitidine, and venetoclax for treating relapsed AML after stem cell transplant

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 clinical trial investigates the efficacy and safety of avapritinib in combination with azacitidine and venetoclax for patients with recurrent acute myeloid leukemia (AML) following allogeneic hematopoietic stem cell transplantation. The study involves a single-center, prospective, single-arm design enrolling 20 patients with specific genetic mutations. Participants undergo an induction therapy period followed by a consolidation therapy period if they achieve complete remission. The treatment regimen includes avapritinib, azacitidine, and venetoclax over a series of 28-day cycles.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects met the criteria for recurrence after allogeneic transplantation: re-emergence of leukemia cells or bone marrow original cells in peripheral blood \>5% (except for other causes such as bone marrow recovery period) or extramedullary leukemia cell infiltration or molecular or cytogenetic recurrence.
2. Bone marrow molecular biology detected C-KIT D816 or C-KIT N822 mutations
3. Patients with CBFB::MYH11 gene or RUNX1::RUNX1T1 fusion gene detected.
4. Eastern Cancer Collaboration Group (ECOG) physical status score 0-2 points.
5. Liver, kidney and cardiopulmonary functions met the following requirements: Within 2 weeks before enrollment ① creatinine ≤1.5 upper limit of normal value; ② Left ventricular ejection fraction ≥50%; ③ Blood oxygen saturation \>91%; ④ Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; Myocardial enzymes \< 2 times the upper limit of normal (for the same age)
6. Volunteer to participate in clinical studies and sign informed consent, willing to follow and able to complete all trial procedures.

Exclusion Criteria:

1. Known allergy to KIT inhibitor drug analogues.
2. Patients who have received previous treatment with Midostaurin.
3. Patients who have previously been treated with mutation-specific C-KIT inhibitors and have developed disease progression during treatment.
4. FLT3-ITD mutation in patients with recurrent/refractory disease (except low gene ratio).
5. HIV infected persons, HBV, HCV active infected persons.
6. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases.
7. With uncontrolled active GVHD (NIH for GVHD diagnosis and classification standards, aGVHD classification refer to the improved Glucksberg standard).
8. Central nervous system leukemia.

Where it's running

• Institute of Hematology & Blood Diseases Hospital
  Tianjin, China Recruiting

Study contacts

• Principal investigator: Erlie Jiang — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Erlie Jiang
• Email: jiangerlie@ihcams.ac.cn
• Phone: 15122538107

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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.