NCT07028073 A New Treatment of Newly Diagnosed KIT Mutation CBF-Acute Myeloid Leukemia
| NCT ID | NCT07028073 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Acute Myeloid Leukemia With T(8;21)(Q22;Q22) |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2025-05-15 |
| Primary Completion | 2027-05-15 |
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.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 78 participants in total. It began in 2025-05-15 with a primary completion date of 2027-05-15.
⚠ 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 goal of this clinical trial is to learn if avapritinib combined with standard induction therapy works to treat newly diagnosed adult acute myeloid leukemia (AML) patients with KIT mutations and t(8;21)(q22;q22.1); inv(16)(p13.1q22) or t(16;16)(p13.1;q22). It will also investigate the safety and tolerability of this combination therapy. The main questions it aims to answer are: To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of avapritinib combined with chemotherapy by Dose-limiting toxicity (DLT). Does this combination therapy improve the rates of minimal residual disease (MRD) negativity and long-term survival outcomes?
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years, both genders * Diagnosis of acute myeloid leukemia according to WHO 2022 criteria * Treatment-naive patients (hydroxyurea or low-dose cytarabine \<0.5g cumulative dose allowed) * Bone marrow detection of KIT mutations with concurrent t(8;21)(q22;q22.1) or RUNX1::RUNX1T1 fusion gene; or inv(16)(p13.1q22) or t(16;16)(p13.1;q22) or CBFβ::MYH11 fusion gene * Life expectancy \>12 weeks Group A: ≥18 and \<65 years with ECOG 0-1; Group B: ≥65 years or ≥18 and \<65 years with comorbidities (ECOG ≥2, cardiac disease, creatinine clearance 30-50ml/min, or mild hepatic impairment) * Adequate organ function: bilirubin ≤2×ULN, ALT/AST ≤3×ULN (≤5×ULN if leukemic infiltration), creatinine clearance ≥30ml/min, left ventricular ejection fraction \>45% Exclusion Criteria: * Known hypersensitivity to KIT inhibitors, cytarabine, idarubicin, venetoclax, azacitidine or similar agents * Concurrent use of other KIT inhibitors (dasatinib, sorafenib, gilteritinib, midostaurin) * Intracranial hemorrhage on imaging or unresolved prior intracranial bleeding * Active uncontrolled infection * Significant organ dysfunction: myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal failure * Pregnancy or breastfeeding
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07028073 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia With T(8;21)(Q22;Q22). 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 NCT07028073 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07028073 currently recruiting?
Yes, NCT07028073 is actively recruiting participants. Contact the research team at chensuning@sina.com for enrollment information.
Where is the NCT07028073 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT07028073 clinical trial?
NCT07028073 is sponsored by The First Affiliated Hospital of Soochow University. The trial plans to enroll 78 participants.
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