Clinical trial · Interventional
Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases
NCT00582894CI-TRIAL-00004721completedN/AResults postedClinicalTrials.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)
To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for malignant hematological diseases
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 |
|---|---|---|---|
| Hematological Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfex, Fludarabine, ALemtuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- A
- description
- Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
- interventionNames
- Drug: Busulfex, Fludarabine, ALemtuzumab
Primary outcomes (2)
- measure
- Number of Participants Experiencing Transplant Related Mortality (TRM)
- timeFrame
- At Day 100 post trans-plant
- measure
- Number of Participants Experiencing Engraftment Donor Chimerism (EDC)
- timeFrame
- At time of study termination
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Performance status 0-2 * Ejection fraction \> 30% * AST/ALT and bilirubin not \> 4 times normal * Creatinine clearance greater than 70 ml/min. * FEV1 greater than 1.0 and diffusion capacity greater than 40% * Age 18-75 years * Patients must be at high risk for conventional regimen related toxicity * Malignant hematologic disease that would otherwise be considered treatable with ASCT Exclusion Criteria: * Does not meet the above Inclusion criteria
References
Publications (0)
Data not yet available
No reference posted for this study.