Efficacy of HAD Induction With Intensified Cytarabine in Newly-diagnosed CEBPA Double Mutated Acute Myeloid Leukemia

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    50
  • sponsor
    wang, jianxiang
Updated on 15 August 2021
cancer
hematologic malignancy
acute leukemia
cytarabine
ejection fraction
daunorubicin
acute promyelocytic leukemia

Summary

Acute myeloid leukemia is a heterogenous hematological malignancy, characterized by different cytogenetic or molecular features. CEBPA double mutation acute myeloid leukemia CEBPAdm AMLhas 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.

Description

In this phase 2 study, 50 patients will be enrolled and treated with HAD induction regimen. High dose cytarabine will be given after complete remission achieved. The primary endpoint was 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, day1-41g/m2 /q12h day5-7 DNR 40mg/m2/dday 1-3 re-induction chemotherapy:IDA 10mg/m2day 1-3 cytarabine 100mg/m2day 1-7 CTX 350mg/m2day 2day 5 consolidation chemotherapy: high dose cytarabine 3g/m2/Q12h,day1-3,for three cycles

Details
Condition CEBPA Double Mutation, acute myeloblastic leukemia, Acute myeloid leukemia, anll, Acute Myeloid Leukemia, Acute Myelogenous Leukemia (AML), acute myelogenous leukemia
Treatment HAD induction with intermediate dose cytarabine
Clinical Study IdentifierNCT04415008
Sponsorwang, jianxiang
Last Modified on15 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

newly-diagnosed of acute myeloid leukemia except acute promyelocytic leukemia
with CEBPA double mutation
age 14 years and<55 yearsmale or female
ECOG-PS score 0-2
laboratory testswithin 7 days before chemotherapy
serum total bilirubin1.5xULN
serum AST and ALT2.5xULN
serum creatinine2xULN
cardiac enzymes2xULN
ejection fraction >50% by ECHO
written informed consent

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
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