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NCT Number: NCT04415008

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

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.

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Key information

Conditions

CEBPA Double Mutation Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

14 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

HBDH

Tianjin, Tianjin Municipality, 300020, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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）
  • 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。

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

Treatment and study plan

HAD induction with intermediate dose cytarabine

Drug

daunorubicin,cytarabine,homoharringtonine

Primary outcomes

  1. event free survival

    Time frame: 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

  2. relapse free survival

    Time frame: 5 years

    survival from complete remission to relapse

Secondary outcomes

  1. complete remission rate

    Time frame: 2.5 years

    incidence of complete remission after induction chemotherapy

  2. early mortality

    Time frame: 2.5 years

    death during 30 days from induction chemotherapy

  3. overall survival

    Time frame: 5 years

    duration from enrollment to death or loss of followup

  4. RFS cencored at stem cell transplantation

    Time frame: 5 years

    RFS cencored at the date of stem cell transplantation

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

A Prospective, Multicenter, Single Arm Clinical Study to Evaluate Efficacy of HAD Induction With Intensified Cytarabine in Newly-diagnosed CEBPA Double Mutated Acute Myeloid Leukemia

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Jun 4, 2020
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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