Clinical trial NCT02937662: Efficacy of Idarubicin, Cytarabine and Cyclophosphamide (IAC) Regimen in Relapsed/Refractory AML
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Complete Remission Rate
timeFrame: Within 6 weeks after induction therapy
Secondary outcomes:
measure: Overall Survival(OS)
timeFrame: Up to 3 years
measure: Relapse-Free Survival(RFS)
timeFrame: Up to 3 years
measure: Time to Treatment Failure(TTF)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
Study officials:
affiliation: Institute of Hematology & Blood Diseases Hospital, China
name: Jianxiang Wang, Dr
role: PRINCIPAL_INVESTIGATOR
References: