A Prospective, Multicenter, Single Arm Clinical Study to Evaluate Efficacy of HAD Induction With Intensified Cytarabine in Newly-diagnosed CEBPA Double Mutated Acute Myeloid Leukemia
Overview
- Phase
- Phase 2
- Intervention
- HAD induction with intermediate dose cytarabine
- Conditions
- CEBPA Double Mutation
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- event free survival
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eligibility Criteria
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）
- •serum total bilirubin≤1.5xULN；
- •serum AST and ALT≤2.5xULN
- •serum creatinine≤2xULN；
- •cardiac enzymes≤2xULN
- •ejection fraction \>50% by ECHO。
Exclusion Criteria
- •subject has received remission induction chemotherapy
- •secondary AML
- •with other hematological malignancy
- •with other tumors(needing treatment)
- •pregnant or lactating women
- •active heart diseases
- •severe active infection
- •unfit for enrollment evaluated by investigator
Arms & Interventions
treatment arm
prospective, open-label, multicenter,single arm
Intervention: HAD induction with intermediate dose cytarabine
Outcomes
Primary Outcomes
event free survival
Time Frame: 5 years
Measured from day 1 of randomization to the date of treatment failure, hematologic relapse from CR or death from any cause, whichever occurs first
relapse free survival
Time Frame: 5 years
survival from complete remission to relapse
Secondary Outcomes
- overall survival(5 years)
- complete remission rate(2.5 years)
- RFS cencored at stem cell transplantation(5 years)
- early mortality(2.5 years)