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

Phase 2

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Physician-Directed Regimens without Cyclophosphamide; Drug: Idarubicin; Drug: Cytarabine; Drug: Cyclophosphamide

• Registration Number: NCT02937662
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-18
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-22
• Primary Completion: 2019-11
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Physician-Directed Regimens without Cyclophosphamide	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.
IAC regimen	Idarubicin	Patients receive IAC regimen including idarubicin, cytarabine and cyclophosphamide.
IAC regimen	Cytarabine	Patients receive IAC regimen including idarubicin, cytarabine and cyclophosphamide.
IAC regimen	Cyclophosphamide	Patients receive IAC regimen including idarubicin, cytarabine and cyclophosphamide.

Primary Outcome Measures

Name	Time	Method
Complete Remission Rate	Within 6 weeks after induction therapy

Secondary Outcome Measures

Name	Time	Method
Relapse-Free Survival(RFS)	Up to 3 years	RFS is defined as the time from the date of complete remission (CR) after entry in this trial until the date of documented relapse or death for subjects who achieve CR.
Overall Survival(OS)	Up to 3 years	OS is defined as the time from the date of randomization until the date of death from any cause.
Time to Treatment Failure(TTF)	Up to 3 years	TTF is defined as the time from the date of randomization until the date of death before response evaluation, not achieving CR or incomplete remission(CRi), or relapse/death after CR/CRi.

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, China