N/A
Completed N=17
Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases
Hematological Neoplasms · Hematopoietic Stem Cell Transplantation
Source: ClinicalTrials.gov NCT00582894 ↗
Enrolled (actual)
17
Serious AEs
5.9%
Results posted
Apr 2011
Primary outcomePrimary: Number of Participants Experiencing Transplant Related Mortality (TRM) — 0 Participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Transplant Related Mortality (TRM) |
— | — |
| PRIMARY Number of Participants Experiencing Engraftment Donor Chimerism (EDC) |
17 | — |
| SECONDARY Number of Participants Relapse-Free |
5 | — |
| SECONDARY Number of Participants Overall Survival as a Function of Time. |
11 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00582894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.