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

Primary Purpose

CEBPA Double Mutation, Acute Myeloid Leukemia

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

HAD induction with intermediate dose cytarabine

About this trial

This is an interventional treatment trial for CEBPA Double Mutation

Eligibility Criteria

14 Years - 55 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

HBDHRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment arm

Arm Description

prospective, open-label, multicenter,single arm

Outcomes

Primary Outcome Measures

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

relapse free survival

survival from complete remission to relapse

Secondary Outcome Measures

complete remission rate

incidence of complete remission after induction chemotherapy

early mortality

death during 30 days from induction chemotherapy

overall survival

duration from enrollment to death or loss of followup

RFS cencored at stem cell transplantation

RFS cencored at the date of stem cell transplantation

Full Information

NCT ID

NCT04415008

First Posted

May 31, 2020

Last Updated

October 3, 2023

Sponsor

wang, jianxiang

1. Study Identification

Unique Protocol Identification Number

NCT04415008

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2020 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

wang, jianxiang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CEBPA Double Mutation, Acute Myeloid Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment arm

Arm Type

Experimental

Arm Description

prospective, open-label, multicenter,single arm

Intervention Type

Drug

Intervention Name(s)

HAD induction with intermediate dose cytarabine

Intervention Description

daunorubicin,cytarabine,homoharringtonine

Primary Outcome Measure Information:

Title

event free survival

Description

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

Time Frame

5 years

Title

relapse free survival

Description

survival from complete remission to relapse

Time Frame

5 years

Secondary Outcome Measure Information:

Title

complete remission rate

Description

incidence of complete remission after induction chemotherapy

Time Frame

2.5 years

Title

early mortality

Description

death during 30 days from induction chemotherapy

Time Frame

2.5 years

Title

overall survival

Description

duration from enrollment to death or loss of followup

Time Frame

5 years

Title

RFS cencored at stem cell transplantation

Description

RFS cencored at the date of stem cell transplantation

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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） 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

Facility Information:

Facility Name

HBDH

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hui Wei

Phone

86-22-23909020

weihui@ihcams.ac.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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