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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
HBDH
Tianjin, Tianjin Municipality, China
composite complete remission (CR) rate
confirmed rate of complete remission (CR) plus complete remission with incomplete blood count(CRi)
Time frame: 8 weeks
mortality during induction chemotherapy
all deaths from start of chemotherapy
Time frame: 30 days
post relapsed overall survival
2 years overall survival from the date of relapse
Time frame: 2 years
overall survival
5 years overall survival from the date of diagnosis
Time frame: 5 years
post relapsed disease free survival
2 years disease free survival from the date of new complete remission
Time frame: 2 years
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