Nonmyeloablative Stem Cell Transplant in Elderly

This study has been completed.
Sponsor:
Information provided by:
Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier:
NCT00382759
First received: September 29, 2006
Last updated: July 31, 2009
Last verified: July 2009
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382759

Locations
Italy
Ospedale San Giovanni Battista
Torino, Italy, 10126
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
Investigators
Principal Investigator: michele falda, md ospedale san giovanni battista
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00382759     History of Changes
Other Study ID Numbers: 012000
Study First Received: September 29, 2006
Last Updated: July 31, 2009
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014