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

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: wang, jianxiang
• Treatments: Cytarabine

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）

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