NCT06316960 Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation
| NCT ID | NCT06316960 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Children's Hospital of Soochow University |
| Condition | AML, Childhood |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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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 50 participants in total. It began in 2024-03-01 with a primary completion date of 2026-03.
⚠ 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
The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation.
Eligibility Criteria
Inclusion Criteria: 1. Gender unlimited; 2. Under 18 years; 3. Diagnosis of acute myeloid leukemia (according to the 2022 WHO classification). 4. Presence of t(8;21)/RUNX1::RUNX1T1 or inv(16)/t(16;16)/CBFβ::MYH11; 5. KIT mutation; 6. Refractory AML: AML patients who do not achieve CR or CRi after induction therapy; 7. Relapsed AML: patients who achieved remission after consolidation therapy or transplantation, FISH confirmed that the fusion gene turned positive, or extramedullary leukemia infiltration; 8. No active infections; 9. Liver function: Tbil ≤2×ULN, ALT/AST ≤3×ULN, creatinine clearance ≥50ml/min; 10. ECOG score \<2; 11. Expected survival time \>12 weeks; 12. Participants must have the ability to understand and be willing to participate in this study and must sign an informed consent form. Exclusion Criteria: 1. Have received prior treatment with avapritinib; 2. Receiving other targeted therapies for AML at the same time, such as dasatinib, sorafenib, gilteritinib, venetoclax, etc; 3. Presence of active uncontrolled infection (including bacterial, fungal, or viral infection); 4. Present of significant underlying organ diseases: such as myocardial infarction, chronic heart failure, decompensated liver or kidney dysfunction； 5. With other malignancies requiring treatment； 6. Already enrolled in another interventional clinical study； 7. The researchers determined that the individual is not suitable to participate in this trial.
Contact & Investigator
Shaoyan Hu, MD, PhD
PRINCIPAL INVESTIGATOR
Children 's Hospital of Soochow University
Frequently Asked Questions
Who can join the NCT06316960 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying AML, Childhood. 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 NCT06316960 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 NCT06316960 currently recruiting?
Yes, NCT06316960 is actively recruiting participants. Contact the research team at hsy139@126.com for enrollment information.
Where is the NCT06316960 trial being conducted?
This trial is being conducted at Hefei, China, Hefei, China, Guangzhou, China, Nanning, China and 8 additional locations.
Who is sponsoring the NCT06316960 clinical trial?
NCT06316960 is sponsored by Children's Hospital of Soochow University. The principal investigator is Shaoyan Hu, MD, PhD at Children 's Hospital of Soochow University. The trial plans to enroll 50 participants.