Status:
ACTIVE_NOT_RECRUITING
Efficacy of HAD Induction With Intensified Cytarabine in Newly-diagnosed CEBPA Double Mutated Acute Myeloid Leukemia
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
CEBPA Double Mutation
Acute Myeloid Leukemia
Eligibility:
All Genders
14-55 years
Phase:
PHASE2
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...
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 an...
Eligibility Criteria
Inclusion
- 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。
- written informed consent。
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2027
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04415008
Start Date
June 1 2020
End Date
June 1 2027
Last Update
June 3 2025
Active Locations (1)
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1
HBDH
Tianjin, Tianjin Municipality, China, 300020