Clinical trial · Interventional
Avapritinib in CBF-AML With KIT Mutations
Avapritinib in Relapsed Refractory or MRD-positive CBF-AML With KIT Mutations
NCT05821738CI-TRIAL-00066293unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
AML with t(8; 21)(q22; q22) or inv(16)(p13; q22)/t(16; 16)(p13; q22) is known as CBF-AML. KIT mutations are common in CBF-AML, which have a worse prognosis.This study is aimed to evaluate the efficacy of Avapritinib, an highly specific inhibitor of the KIT gene, in CBF-AML with KIT mutations.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Core Binding Factor Acute Myeloid Leukemia | Core Binding Factor Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
| KIT Mutation-Related Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avapritinib | Drug | Avapritinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- The treatment group will receive avapritinib orally. The dosage is 100mg to 300mg qd, allowed to combine with other chemotheray drugs.
- interventionNames
- Drug: Avapritinib
Primary outcomes (1)
- measure
- Composite complete remission (CRc)
- timeFrame
- Assessed at protocol-defined timepoints through end of study, up to approximately 36 months.
- description
- The proportion of participants who achieve Composite complete remission (CRc)，which includes complete remission (CR)、CR with partial hematologic recovery (CRh)、CR with incomplete blood count recovery (CRi) and morphology leukemia free (MLFS) based on response criteria for AML.
Secondary outcomes (4)
- measure
- MRD-negative rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with acute myeloid leukemia accompanied by t(8; 21)/RUNX1-RUNX1T1, or inv(16)/t(16; 16)/CBFβ-MYH11; 2. Accompanied by KIT mutation 3. Disease recurrence after the first remission, or the mol-MRD remains positive after the morphologic remission of AML. 4. No active infection. 5. Liver function: TBIL≤ 2×ULN,ALT/AST≤ 3×ULN, CCr ≥ 50ml/min，NYHA grading ≤2; SaO2 \>92%. 6. ECOG \<2; (11) Predicted survival \> 12 weeks. Exclusion Criteria: 1. Accept other AML targeted therapies, such as dasatinib, sorafenib, gilteritinib, etc. simultaneously; 2. The presence of uncontrolled and active infections (including bacterial, fungal or viral infections). 3. Underlying diseases such as myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal failure, etc. 4. Pregnant or lactating women; 5. Accompanied by other malignant tumors requiring treatment; 6. Other interventional clinical studies have been enrolled.
References
Publications (0)
Data not yet available
No reference posted for this study.