Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation (NCT06316960) | Clinical Trial Compass
RecruitingPhase 2
Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation
China50 participantsStarted 2024-03-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Gender unlimited;
✓. Under 18 years;
✓. Diagnosis of acute myeloid leukemia (according to the 2022 WHO classification).
✓. Presence of t(8;21)/RUNX1::RUNX1T1 or inv(16)/t(16;16)/CBFβ::MYH11;
✓. KIT mutation;
✓. Refractory AML: AML patients who do not achieve CR or CRi after induction therapy;
✓. Relapsed AML: patients who achieved remission after consolidation therapy or transplantation, FISH confirmed that the fusion gene turned positive, or extramedullary leukemia infiltration;
✓. No active infections;
Exclusion criteria
✕. Have received prior treatment with avapritinib;
✕. Receiving other targeted therapies for AML at the same time, such as dasatinib, sorafenib, gilteritinib, venetoclax, etc;
✕. Presence of active uncontrolled infection (including bacterial, fungal, or viral infection);
✕. Present of significant underlying organ diseases: such as myocardial infarction, chronic heart failure, decompensated liver or kidney dysfunction；
✕. With other malignancies requiring treatment；
What they're measuring
1
Composite remission rate (CRc)
Timeframe: The evaluation time point is day28-day35 from the start of regimen.