Clinical trial · Observational
Study of New RIC Regimen of BuFlu in Older and/or Intolerable Patients
The Study of New RIC Regimen of BuFlu in Older or Intolerable Patients With Hematologic Malignant Diseases
NCT01828619CI-TRIAL-00009974unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine whether the new RIC regimen, containing of low dose of Bu (9.6mg/kg)and fludarabine without ATG, is suitable and effective in treating aged and/or intolerable patients with hematologic malignant disease, who undergoes allogenic stem cell transplantation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| modified BuFlu conditioning | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- modified BuFlu, HSCT, elder/intolerable
- description
- The study group is the hematlogic malignant patients that older than 55years and/or with severe concurrent medical conditions, who will undergo HLA-matced allogenic HSCT to cure the disease. The patients will received a modified BuFlu conditioning.
- interventionNames
- Procedure: modified BuFlu conditioning
Primary outcomes (1)
- measure
- stem cell engraftment
- timeFrame
- 30day post transplantation
Secondary outcomes (1)
- measure
- toxicity and treatment related mortality
- timeFrame
- 100day and 1 year post transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosed of hematologic malignant disease * will undergo HLA matced HSCT * age \>=55years * \<55year and intolerable to standard myeloablative conditioning Exclusion Criteria: * KPS status \<70 * cardiac EF\<50% * creatine clearance \<50 ml/min * ALT more than 10 times of upper normal limit
References
Publications (2)
- BACKGROUNDBarrett AJ, Savani BN. Stem cell transplantation with reduced-intensity conditioning regimens: a review of ten years experience with new transplant concepts and new therapeutic agents. Leukemia. 2006 Oct;20(10):1661-72. doi: 10.1038/sj.leu.2404334. Epub 2006 Jul 27. PMID 16871277
- BACKGROUNDde Lima M, Couriel D, Thall PF, Wang X, Madden T, Jones R, Shpall EJ, Shahjahan M, Pierre B, Giralt S, Korbling M, Russell JA, Champlin RE, Andersson BS. Once-daily intravenous busulfan and fludarabine: clinical and pharmacokinetic results of a myeloablative, reduced-toxicity conditioning regimen for allogeneic stem cell transplantation in AML and MDS. Blood. 2004 Aug 1;104(3):857-64. doi: 10.1182/blood-2004-02-0414. Epub 2004 Apr 8. PMID 15073038