Acute Myeloid Leukemia Clinical Trial
— IDBUCYOfficial title:
A Multi-center, Open, Randomized-control Study to Compare the Effects and Safety of Idarubicin-strengthened Pretreatment Program and Conventional Busulfan Cyclophosphamide Pretreatment Program on High-risk Acute Myeloid Leukemia Patient
This study was a multi-center, open, randomized-control study on the effects and safety of idarubicin 60mg/M2 combined with BUCY pretreatment program or BUCY pretreatment program on the overall survival rate and disease-free survival rate of acute myeloid leukemia patient in high-risk group over a period of 2 years.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: 1. Age: 18~50; 2. Received peripheral blood hematopoietic stem cell transplantation from siblings or unrelated allogeneic donors with identical matching of HLA or 1 alleles mismatched. 3. Diagnosis: refer to 2011 edition of AML China Guideline for the diagnosis and treatment and diagnosis standards of high-risk acute myeloid leukemia developed through literatures (see Appendix B); 4. Under general condition, ECOG score = 1; 5. Normal cardiac functions; 6. Normal liver and renal function: blood bilirubin=35 µ mol\/L, AST/ALT lower than twice in the upper limit of normal value, serum creatinine= 150 µ mol\/L; 7. Subjects have signed the informed consent form. Exclusion Criteria: 1. Severe uncontrolled infection before transplantation; 2. With contraindications of idarubicin; 3. Reached the maximum cumulative dose of anthracyclines, for instance, DNR= 450mg/m2, mitoxantrone=140mg/m2, the total cumulative dose of idarubicin= 300mg/m2; 4. The other conditions that do not meet the inclusion criteria. Withdrawal criteria: 1. Those do not meet the inclusion criteria or meet the exclusion criteria after reviewing; 2. Patient withdraws the informed consent form; 3. Patient violates the clinical study protocol; 4. Patient experiences severe adverse events that treatment has to be terminated; 5. Patient that considered no longer fit to complete clinical trials by researchers. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi |
Lead Sponsor | Collaborator |
---|---|
Guangxi Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | safety of idarubicin 60mg/M2 combined with BUCY pretreatment program or BUCY pretreatment program | safety evaluation (early complications of transplantation, liver, kidney and heart toxicity, treatment-related mortality, blood recovery time), | 4 years | Yes |
Primary | 2-year disease-free survival (DFS) rates | The purpose of this study is to evaluates the effects of idarubicin 60mg/M2 combined with BUCY pretreatment program or BUCY pretreatment program on acute myeloid leukemia patient in high-risk group. | 4 years | No |
Secondary | 2-year overall survival (OS) rates | It evaluates the effects of idarubicin 60mg/M2 combined with BUCY pretreatment program or BUCY pretreatment program on acute myeloid leukemia patient in high-risk group. 200 patients were studied with 100 patients in each group | 4 years | No |
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