Nonmyeloablative Stem Cell Transplant in Elderly
- Conditions
- Hematological Malignancies
- Registration Number
- NCT00382759
- Lead Sponsor
- Azienda Ospedaliera San Giovanni Battista
- Brief Summary
The study aimed to evaluate the efficacy of a nonmyeloablative conditioning consisting of fludarabine and total body irradiation in patients older than 60 years of age
- Detailed Description
A total of 35 patients with hematological malignancies were treated with fludarabine (30 mg/m2 x 3-5 days) and 200 cCy TBI followed by allogeneic hematopoietic stem cell transplantation (HSCT) from a matched-sibling donor.
Neutrophil recovery occurred in 89% of the patients at a median time of 15 days. On day +30, 10 patients had \> 95% donor chimerism, and 21 patients had mixed chimerism. The cumulative probabilities of grade II-IV acute GVHD and chronic GVHD were 51% and 84% respectively. Transplant-related mortality at 100 days and 1 year was 5% and 9% respectively. The probabilities of 1-year overall (OS) and progression-free survival (PFS) were 55% and 47% respectively. The estimated 1-year probability of OS and PFS for patients in early disease stages were 87% and 74% respectively , which were significantly higher than the survival and PFS estimates of 12% obtained in patients with advanced disease stages at the time of transplant
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- patients with myeloid or lymphoid malignancy who were > 60 years old potentially treatable with stem cell transplant
- lack of an HLA-identical sibling donor
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method overall survival progression-free survival transplant-related mortality
- Secondary Outcome Measures
Name Time Method acute GVHD chronic GVHD
Trial Locations
- Locations (1)
Ospedale San Giovanni Battista
🇮🇹Torino, Italy