Back to resultsNonmyeloablative Stem Cell Transplant in Elderly
Primary Purpose
Hematological Malignancies
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
stem cell transplant
Sponsored by
About this trial
This is an interventional treatment trial for Hematological Malignancies
Eligibility Criteria
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
Sites / Locations
- Ospedale San Giovanni Battista
Outcomes
Primary Outcome Measures
overall survival
progression-free survival
transplant-related mortality
Secondary Outcome Measures
acute GVHD
chronic GVHD
Full Information
NCT ID
NCT00382759
First Posted
September 29, 2006
Last Updated
July 31, 2009
Sponsor
Azienda Ospedaliera San Giovanni Battista
1. Study Identification
Unique Protocol Identification Number
NCT00382759
Brief Title
Nonmyeloablative Stem Cell Transplant in Elderly
Official Title
Nonmyeloablative Allogeneic Stem Cell Transplantation in Elderly Patients With Hematological Malignancies:Results From the GITMO (Gruppo Italiano Trapianto Midollo Osseo)Multicenter Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Azienda Ospedaliera San Giovanni Battista
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
stem cell transplant
Primary Outcome Measure Information:
Title
overall survival
Title
progression-free survival
Title
transplant-related mortality
Secondary Outcome Measure Information:
Title
acute GVHD
Title
chronic GVHD
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
michele falda, md
Organizational Affiliation
ospedale san giovanni battista
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale San Giovanni Battista
City
Torino
ZIP/Postal Code
10126
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Nonmyeloablative Stem Cell Transplant in Elderly
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