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

NCT ID: NCT04415008

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2027-06-01

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

Conditions

CEBPA Double Mutation; Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment arm

prospective, open-label, multicenter,single arm

Group Type: EXPERIMENTAL

HAD induction with intermediate dose cytarabine

Intervention Type: DRUG

daunorubicin,cytarabine,homoharringtonine

Interventions

HAD induction with intermediate dose cytarabine

daunorubicin,cytarabine,homoharringtonine

Intervention Type: DRUG

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）

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HBDH

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

IIT2020008

Identifier Type: -

Identifier Source: org_study_id