Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00382759
Status:
COMPLETED
Last Update Posted:
2009-08-03
First Post:
2006-09-29
Brief Title:
Nonmyeloablative Stem Cell Transplant in Elderly
Sponsor:
Azienda Ospedaliera San Giovanni Battista
Organization:
Azienda Ospedaliera San Giovanni Battista
Study Overview
Official Title:
Nonmyeloablative Allogeneic Stem Cell Transplantation in Elderly Patients With Hematological MalignanciesResults From the GITMO Gruppo Italiano Trapianto Midollo OsseoMulticenter Prospective Clinical Trial
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgm2 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None