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

Acute Myeloid Leukemia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02937662
• Other study ID #: IHBDH-IIT2016006
• Status: Recruiting
• Phase: Phase 2
• Start date: October 2016
• Est. completion date: December 2019

Study information

• Verified date: March 2019
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: Lijun Liu
• Phone: 86-22-23909237
• Email: bloodgcp[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Idarubicin
Idarubicin at a dose of 10 mg/?/d on days 1-3.
• Cytarabine
Cytarabine at a dose of 100mg/?/d on days 1-7.
• Cyclophosphamide
Cyclophosphamide at a dose of 350mg/?/d on the second day and the fifth day.
• Physician-Directed Regimens without Cyclophosphamide
Regimen without cyclophosphamide including FLA±G regimen, DA regimen, AAG regimen, decitabine with AA regimen.

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Remission Rate		Within 6 weeks after induction therapy
Secondary	Overall Survival(OS)	OS is defined as the time from the date of randomization until the date of death from any cause.	Up to 3 years
Secondary	Relapse-Free Survival(RFS)	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.	Up to 3 years
Secondary	Time to Treatment Failure(TTF)	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.	Up to 3 years