NCT06783790 Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed AML After Allo-HSCT
| NCT ID | NCT06783790 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | AML (Acute Myelogenous Leukemia) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-01-20 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single-center, prospective, single-arm, exploratory clinical study. To explore the efficacy and safety of avapritinib in patients with recurrent acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation with C-KIT mutation RUNX1::RUNX1T1 or CBFB::MYH11.
Eligibility Criteria
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.
Contact & Investigator
Erlie Jiang
PRINCIPAL INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Frequently Asked Questions
Who can join the NCT06783790 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying AML (Acute Myelogenous Leukemia). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06783790 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06783790 currently recruiting?
Yes, NCT06783790 is actively recruiting participants. Contact the research team at jiangerlie@ihcams.ac.cn for enrollment information.
Where is the NCT06783790 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06783790 clinical trial?
NCT06783790 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Erlie Jiang at Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 20 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.