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

W

wang, jianxiang

Status and phase

Enrolling
Phase 2

Conditions

CEBPA Double Mutation
Acute Myeloid Leukemia

Treatments

Drug: HAD induction with intermediate dose cytarabine

Study type

Interventional

Funder types

Other

Identifiers

NCT04415008
IHBD-IIT2020008

Details and patient eligibility

About

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.

Full 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

Enrollment

40 estimated patients

Sex

All

Ages

14 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

treatment arm
Experimental group
Description:
prospective, open-label, multicenter,single arm
Treatment:
Drug: HAD induction with intermediate dose cytarabine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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