the Effects and Safety of Idarubicin-strengthened Pretreatment Program and Conventional Busulfan Cyclophosphamide Pretreatment Program on High-risk Acute Myeloid Leukemia Patient

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangxi Medical University
• Treatments: Busulfan; Cyclophosphamide; Cyclosporine; Cyclosporins; Idarubicin; Methotrexate; Mycophenolate mofetil; Mycophenolic Acid

Criteria

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.