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

NCT04415008 | Active Not Recruiting Phase 2

• 1 other identifier: IIT2020008
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

CEBPA Double Mutation; Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• event free survival

  Measured from day 1 of randomization to the date of treatment failure, hematologic relapse from CR or death from any cause, whichever occurs first

  5 years

• relapse free survival

  survival from complete remission to relapse

  5 years

Secondary Outcomes (4)

• complete remission rate

  2.5 years

• early mortality

  2.5 years

• overall survival

  5 years

• RFS cencored at stem cell transplantation

  5 years

Study Arms (1)

treatment arm

EXPERIMENTAL

prospective, open-label, multicenter,single arm

Drug: HAD induction with intermediate dose cytarabine

Interventions

HAD induction with intermediate dose cytarabine DRUG

daunorubicin,cytarabine,homoharringtonine

treatment arm

Eligibility Criteria

• Age: 14 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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。

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

HBDH

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2020
• First Posted: June 4, 2020
• Study Start: June 1, 2020
• Primary Completion (Estimated): October 3, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)