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Acute myeloid leukemia is a heterogenous hematological malignancy, characterized by different cytogenetic or molecular features. CEBPA double mutation acute myeloid leukemia (CEBPAdm AML)has favourite prognosis, especially in younger adult patients. But cumulative incidence of relapse of this group patients is still high, so the treatment options need to be optimized urgently.HAD(homoharringtonine(HHT)+cytarabine+daunorubicin) with intermediate dose cytarabine improved the survival of AML, especially in patients with CEBPA double mutation.
In this phase 2 study, 40 patients will be enrolled and treated with HAD induction regimen. High dose cytarabine will be given after complete remission achieved. The primary endpoint was event-free and relapse-free survival. Genetic mutations and measurable residual disease (MRD) will be detected at diagnosis and after chemotherapy. The risk stratification according to genetic mutations and MRD will also be explored.
induction chemotherapy:HHT 2mg/m2/d,day 1-7 cytarabine 100mg/m2/d, day1-4;1g/m2 /q12h ,day5-7 DNR 40mg/m2/d,day 1-3 re-induction chemotherapy:IDA 10mg/m2,day 1-3 cytarabine 100mg/m2,day 1-7 CTX 350mg/m2,day 2,day 5 consolidation chemotherapy: high dose cytarabine 3g/m2/Q12h,day1-3,for three cycles
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental | prospective, open-label, multicenter,single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAD induction with intermediate dose cytarabine | Drug | daunorubicin,cytarabine,homoharringtonine |
|
| Measure | Description | Time Frame |
|---|---|---|
| event free survival | Measured from day 1 of randomization to the date of treatment failure, hematologic relapse from CR or death from any cause, whichever occurs first | 5 years |
| relapse free survival | survival from complete remission to relapse | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| complete remission rate | incidence of complete remission after induction chemotherapy | 2.5 years |
| early mortality | death during 30 days from induction chemotherapy |
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Inclusion Criteria:
newly-diagnosed of acute myeloid leukemia except acute promyelocytic leukemia
with CEBPA double mutation
age≥ 14 years and<55 years,male or female
ECOG-PS score 0-2
laboratory tests(within 7 days before chemotherapy)
written informed consent。
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HBDH | Tianjin | Tianjin Municipality | 300020 | China |
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| 2.5 years |
| overall survival | duration from enrollment to death or loss of followup | 5 years |
| RFS cencored at stem cell transplantation | RFS cencored at the date of stem cell transplantation | 5 years |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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