Starting soon
Phase 2
Avapritinib Maintenance for AML With KIT Mutations
Condition(s) studied
AML, Adult
Investigational drug(s) / intervention(s)
Avapritinib: After allo-HSCT, CBF-AML patients who have kit mutation would receive avapritinib for maintenance therapy.
Study summary
A multicenter, single-arm clinical study of evaluate the efficacy and safety of avapritinib as maintenance therapy following allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia patients with KIT mutation.
Eligibility
Inclusion Criteria:
* Age≥ 14 years old;
* First allo-HSCT for AML (including secondary AML) ;
* KIT mutation at diagnosis (no restriction on locus for kit mutation
* CR and negative MFC-MRD prior to initiation of maintenance therapy;
* Absolute neutrophil count ≥ 1.0 x 109 /L, platelets ≥ 75 x 109 /L, hemoglobin ≥ 80 g/L before maintenance;
* Normal functioning of major organs and laboratory findings in accordance with the following criteria:AST and ALT) ≤ 3x ULN; Total serum bilirubin ≤ 1.5x ULN unless the patient has Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included; HB ≥ 70 g/L (had not received a red blood cell transfusion within 1 week prior to administration); ANC ≥ 0.8 x 10\^9/L (had not received long-acting colony-stimulating factor (LACSF) within 1 week prior to administration and short-acting colony-stimulating factor (SACSF) within 3 days prior to administration); Platelet count ≥ 20 x 10\^9/L (had not received a platelet transfusion within 1 week prior to administration); serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 60 mL/min; Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN, Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN; Left ventricular ejection fraction (LVEF) ≥45%;
* ECOG PS 0-2 points;
* Expected survival ≥ 3 months;
* Patient consent
Exclusion Criteria:
* concurrently receiving other targeted therapies for AML;
* Prior treatment with a TKI inhibitor that proved ineffective;
* with concurrent FLT3-ITD mutations at enrollment;
* Acute/chronic graft-versus-host disease requiring systemic immunosuppressive therapy prior to maintenance therapy;
* Accompanied by other malignant tumors requiring treatment;
* Have important organ-based diseases: e.g., myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal failure;
* Active, uncontrolled infection;
* HIV-positive, active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral therapy;
* Other interventional clinical studies have been enrolled;
* Men and women of childbearing potential are unwilling to use contraception during and for 12 months after treatment;
* The investigator believes that there are other conditions that make the patient unsuitable for participation in this study.
Primary outcome measure(s)
- Cumulative incidence of relapse — through study completion, an average of 2 year
disease relapse
Trial sites (1)
| Facility | City | Region | Status |
| Ruijin Hospital of Shanghai Jiaotong University |
Shanghai |
Shanghai Municipality |
|
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