C-KIT Mutation, Relapsed AML, T(8;21)
Conditions
Keywords
leukemia,myeloid, acute, relapse, mutation, KIT, dasatinib
Brief summary
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.
Interventions
DRUGDasatinib
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.
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. T(8;21)acute myeloid leukemia patients with KIT D816 mutation diagnosed by bone marrow morphology, immunology, molecular genetics. The diagnosis and classification are according to WHO 2016 criteria. 2. Conform to relapsed diagnosis.Only morphological relapsed cases will be enrolled.Molecular relapsed and isolated extramedullary relapsed cases are not eligible. 3. Age is not limited. Both male and female are eligible. 4. Eastern Cooperative Oncology Group performance status (ECOG-PS):0-2 point. 5. Informed consent form must be signed by patients themselves before enrolled for patients aged 18 years or older. Informed consent form must be signed by the legal guardian for patients younger than 18 years.
Exclusion criteria
1. Patients with other blood diseases at the same time (such as haemophilia, primary myelofibrosis and so on) are not considered suitable. 2. Isolated extramedullary relapsed leukemia. 3. With other malignant tumors accompanied with AML and needed treatment. 4 .Patients who are unsuitable for the trial considered by investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| composite complete remission (CR) rate | 8 weeks | confirmed rate of complete remission (CR) plus complete remission with incomplete blood count(CRi) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mortality during induction chemotherapy | 30 days | all deaths from start of chemotherapy |
| post relapsed overall survival | 2 years | 2 years overall survival from the date of relapse |
| overall survival | 5 years | 5 years overall survival from the date of diagnosis |
| post relapsed disease free survival | 2 years | 2 years disease free survival from the date of new complete remission |
Countries
China
Outcome results
None listed