Phase
Condition
Leukemia
Treatment
Avapritinib, azacitidine, Venetoclax
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 extramedullaryleukemia cell infiltration or molecular or cytogenetic recurrence.
Bone marrow molecular biology detected C-KIT D816 or C-KIT N822 mutations
Patients with CBFB::MYH11 gene or RUNX1::RUNX1T1 fusion gene detected.
Eastern Cancer Collaboration Group (ECOG) physical status score 0-2 points.
Liver, kidney and cardiopulmonary functions met the following requirements: Within 2weeks before enrollment ① creatinine ≤1.5 upper limit of normal value; ② Leftventricular ejection fraction ≥50%; ③ Blood oxygen saturation >91%; ④ Totalbilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; Myocardial enzymes < 2 times the upperlimit of normal (for the same age)
Volunteer to participate in clinical studies and sign informed consent, willing tofollow and able to complete all trial procedures.
Exclusion
Exclusion Criteria:
Known allergy to KIT inhibitor drug analogues.
Patients who have received previous treatment with Midostaurin.
Patients who have previously been treated with mutation-specific C-KIT inhibitorsand have developed disease progression during treatment.
FLT3-ITD mutation in patients with recurrent/refractory disease (except low generatio).
HIV infected persons, HBV, HCV active infected persons.
Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulationdisorders, connective tissue diseases, serious infectious diseases and otherdiseases.
With uncontrolled active GVHD (NIH for GVHD diagnosis and classification standards,aGVHD classification refer to the improved Glucksberg standard).
Central nervous system leukemia.
Study Design
Study Description
Connect with a study center
Institute of Hematology & Blood Diseases Hospital
Tianjin,
ChinaActive - Recruiting
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