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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib plus chemotherapy | Experimental | Dasatinib combined with chemotherapy for relapsed t(8;21) AML with D816 mutation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| composite complete remission (CR) rate | confirmed rate of complete remission (CR) plus complete remission with incomplete blood count(CRi) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| mortality during induction chemotherapy | all deaths from start of chemotherapy | 30 days |
| post relapsed overall survival | 2 years overall survival from the date of relapse |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianxiang Wang, Dr. | Institute of Hematology & Blood Diseases Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HBDH | Tianjin | Tianjin Municipality | 300020 | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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|
| 2 years |
| overall survival | 5 years overall survival from the date of diagnosis | 5 years |
| post relapsed disease free survival | 2 years disease free survival from the date of new complete remission | 2 years |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |