Clinical trial · Interventional
the Effects and Safety of Idarubicin-strengthened Pretreatment Program and Conventional Busulfan Cyclophosphamide Pretreatment Program on High-risk Acute Myeloid Leukemia Patient
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclosporin A,mycophenolate mofetil,Methotrexate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IDBUCY
- description
- Idarubicin: 20mg/m2 a day, d-12 \~d-10, intravenous infusion for 1 hour. Busulfan: 4mg/Kg a day, oral administration, d-7 \~d-4, or 3.2mg/Kg a day, intravenous infusion, d-7\~d-4. cyclophosphamide: 60mg/Kg a day, intravenous infusion, d-3\~d-2.
- interventionNames
- Drug: Cyclosporin A,mycophenolate mofetil,Methotrexate
- type
- ACTIVE_COMPARATOR
- label
- BUCY
- description
- Busulfan: 4mg/Kg a day, oral administration, d-7 \~d-4, or 3.2mg/Kg a day, intravenous infusion, d-7\~d-4. Cyclophosphamide: 60mg/Kg a day, intravenous infusion, d-3\~d-2.
- interventionNames
- Drug: Cyclosporin A,mycophenolate mofetil,Methotrexate
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available