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Nonmyeloablative Stem Cell Transplant in Elderly

This study has been completed.
Information provided by:
Azienda Ospedaliera San Giovanni Battista Identifier:
First received: September 29, 2006
Last updated: July 31, 2009
Last verified: July 2009
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

Condition Intervention Phase
Hematological Malignancies Procedure: stem cell transplant Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Azienda Ospedaliera San Giovanni Battista:

Primary Outcome Measures:
  • overall survival
  • progression-free survival
  • transplant-related mortality

Secondary Outcome Measures:
  • acute GVHD
  • chronic GVHD

Enrollment: 50
Study Start Date: March 2000
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00382759

Ospedale San Giovanni Battista
Torino, Italy, 10126
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
Principal Investigator: michele falda, md ospedale san giovanni battista
  More Information Identifier: NCT00382759     History of Changes
Other Study ID Numbers: 012000
Study First Received: September 29, 2006
Last Updated: July 31, 2009

Additional relevant MeSH terms:
Neoplasms processed this record on August 22, 2017