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Dasatinib combined with chemotherapy for relapsed t(8;21) AML with D816 mutation

Dasatinib 70mg twice a day will be administered orally for 2 weeks along with re-induction chemotherapy from day 1 of chemotherapy. Recommended re-induction regimens include (1)FLAG: Fludarabine 30mg/m2/d,d1-5;cytarabine 1g-2g/m2/d,d1-5;±G-CSF;(2)IA/DA:idarubicin 8-12mg/m2/d,d1-3 or daunorubicin 45-60mg/m2/d，d1-3;cytarabine 100-200mg/m2/d，d1-7;(3)CAG:Aclarubicin 20mg/d,d1-4；cytarabine 15mg/m2/Q12h,d1-14; ±G-CSF.The chemotherapy regimen is not limited to recommended regimens. Patients will be recommended to receive allogeneic hematopoietic stem cell transplantation (HSCT) once complete remission is achieved. Otherwise, they will continue the consolidation chemotherapy.

Jianxiang Wang, Dr.

In this multi-center, open-label, no control,prospective clinical trial, a total of 30 relapsed acute myeloid leukemia with t(8;21) translocation and KIT D816 mutation patients will be enrolled. Dasatinib 70 mg twice a day will be administrated for two weeks from day 1 of re-induction chemotherapy. The purpose of current study is to determine the clinical efficacy and tolerability of combination therapy of dasatinib with multi-agent chemotherapy in relapsed acute myeloid leukemia with t(8;21) translocation and KIT D816 mutation.

Dasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation

Dasatinib Combined With Multi-agents Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation

confirmed rate of complete remission (CR) plus complete remission with incomplete blood count(CRi)

2 years overall survival from the date of relapse

5 years overall survival from the date of diagnosis

2 years disease free survival from the date of new complete remission

Institute of Hematology & Blood Diseases Hospital, China

Vice President of Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation	NCT03560908	Relapsed AML T(8;21) C-KIT Mutation	Dasatinib	-	Institute of Hematology & Blood Diseases Hospital, China
Dasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation	NCT03560908	Relapsed AML T(8;21) C-KIT Mutation	Dasatinib	-	Institute of Hematology & Blood Diseases Hospital, China
Dasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation	NCT03560908	Relapsed AML T(8;21) C-KIT Mutation	Dasatinib	-	Institute of Hematology & Blood Diseases Hospital, China

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