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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04415008
• Other study ID #: IHBD-IIT2020008
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: October 2023
• Source: Institute of Hematology & Blood Diseases Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• CEBPA Double Mutation
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• HAD induction with intermediate dose cytarabine
daunorubicin,cytarabine,homoharringtonine

Locations

Country	Name	City	State
China	HBDH	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
wang, jianxiang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	relapse free survival	survival from complete remission to relapse	5 years
Secondary	complete remission rate	incidence of complete remission after induction chemotherapy	2.5 years
Secondary	early mortality	death during 30 days from induction chemotherapy	2.5 years
Secondary	overall survival	duration from enrollment to death or loss of followup	5 years
Secondary	RFS cencored at stem cell transplantation	RFS cencored at the date of stem cell transplantation	5 years