Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 2
Started
2020-06-01
Last updated
2025-06-03
Condition(s) studied
CEBPA Double MutationAcute Myeloid Leukemia
Investigational drug(s) / intervention(s)
HAD induction with intermediate dose cytarabine
HAD induction with intermediate dose cytarabine: daunorubicin,cytarabine,homoharringtonine
Study 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.
Eligibility
Sex
ALL
Min age
14 Years
Max age
55 Years
Healthy volunteers
No
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）
1. serum total bilirubin≤1.5xULN；
2. serum AST and ALT≤2.5xULN
3. serum creatinine≤2xULN；
4. cardiac enzymes≤2xULN
5. 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
Primary outcome measure(s)
event free survival — 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 — 5 years survival from complete remission to relapse
Trial sites (1)
Facility
City
Region
Status
HBDH
Tianjin
Tianjin Municipality
More Institute of Hematology & Blood Diseases Hospital, China trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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