Hematological Malignancies
Conditions
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
Interventions
PROCEDUREstem cell transplant
Sponsors
Azienda Ospedaliera San Giovanni Battista
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with myeloid or lymphoid malignancy who were \> 60 years old potentially treatable with stem cell transplant
Exclusion criteria
* lack of an HLA-identical sibling donor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
| progression-free survival | — |
| transplant-related mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| acute GVHD | — |
| chronic GVHD | — |
Countries
Italy
Outcome results
None listed