Efficacy of Idarubicin, Cytarabine and Cyclophosphamide (IAC) Regimen in Relapsed/Refractory AML

NCT ID: NCT02937662

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2020-04-30

Brief Summary

In this multi-center, randomized, open-label, prospective clinical trial, a total of 60 relapsed/refractory AML patients will be randomized into 2 groups. In the experimental arm, patients receive IAC regimen. In the control arm, patients receive other physician-directed regimen. The primary end point is complete remission rate.

Detailed Description

In this multi-center, randomized, open-label, prospective clinical trial, a total of 60 relapsed/refractory AML patients will be randomized into 2 groups. Patients in the IAC arm receive the therapy consisting of idarubicin 10 mg/㎡/d on days 1-3, cytarabine 100mg/㎡/d on days 1-7 and cyclophosphamide at a dose of 350mg/㎡/d on the second day and the fifth day. In the control arm, patients received other physician-directed regimen including fludarabine, cytarabine with/without granulocyte stimulating factor(FLA±G) regimen,cytarabine plus daunorubicin(DA）regimen , decitabine,aclacinomycin and cytarabine(decitabine plus AA) regimen or AA regimen plus granulocyte stimulating factor. All the regimen in the control arm can not contain cyclophosphamide. The primary end point is complete remission. The second end points include overall survival, relapse-free survival and time to treatment failure.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IAC regimen

Patients receive IAC regimen including idarubicin, cytarabine and cyclophosphamide.

Group Type: EXPERIMENTAL

Idarubicin

Intervention Type: DRUG

Idarubicin at a dose of 10 mg/㎡/d on days 1-3.

Cytarabine

Intervention Type: DRUG

Cytarabine at a dose of 100mg/㎡/d on days 1-7.

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide at a dose of 350mg/㎡/d on the second day and the fifth day.

Control Group

Patients receive physician-directed regimens without cyclophosphamide including FLA±G regimen, AAG regimen, decitabine with AA regimen. Physicians can choose one of these regimens based on their experience and patients' condition.

Group Type: ACTIVE_COMPARATOR

Physician-Directed Regimens without Cyclophosphamide

Intervention Type: DRUG

Regimen without cyclophosphamide including FLA±G regimen, DA regimen, AAG regimen, decitabine with AA regimen.

Interventions

Idarubicin

Idarubicin at a dose of 10 mg/㎡/d on days 1-3.

Intervention Type: DRUG

Cytarabine

Cytarabine at a dose of 100mg/㎡/d on days 1-7.

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide at a dose of 350mg/㎡/d on the second day and the fifth day.

Intervention Type: DRUG

Physician-Directed Regimens without Cyclophosphamide

Regimen without cyclophosphamide including FLA±G regimen, DA regimen, AAG regimen, decitabine with AA regimen.

Intervention Type: DRUG

Other Intervention Names

Ara-c; CTX

Eligibility Criteria

Inclusion Criteria

1. Age of less than 60 years old;

2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).

3. Patients with a confirmed pathologic diagnosis of AML which had relapsed or refractory.

4. Patients with ECOG score of ≤ 2;

5. Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.

Exclusion Criteria

1. Patients who had received reinduction therapy including cyclophosphamide are excluded. However, patients who had received regimens including cyclophosphamide before relapse are eligible.

2. Patients with other blood diseases(for example, haemophiliacs) are excluded.

3. Relapsed patients with only extramedullary leukemia;

4. After allogeneic hematopoietic stem cell transplantation;

5. With mutation of breakpoint cluster region-Abelson(BCR-ABL) fusion gene and in need of tyrosine kinase inhibitors therapy;

6. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;

7. Had other malignant tumor in need of treatment;

8. Had active cardiovascular disease;

9. Patients with other factors which were considered unsuitable to participate in the study by the investigators.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianxiang Wang, Dr

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology & Blood Diseases Hospital, China

Locations

Institute of Hematology & Blood Diseases Hospital

Tianjin, , China

Countries

China

Other Identifiers

IIT2016006

Identifier Type: -

Identifier Source: org_study_id