Nonmyeloablative Stem Cell Transplant in Elderly

• Sponsor: Azienda Ospedaliera San Giovanni Battista (Other)
• Overall Status: Completed
• CT.gov ID: NCT00382759
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 84
• Patients Per Site Per Month: 0.6

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Hematological Malignancies	Procedure: stem cell transplant	Phase 2/Phase 3

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• 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
• Study Start Date: Mar 1, 2000
• Actual Primary Completion Date: Mar 1, 2007
• Actual Study Completion Date: Mar 1, 2007

Outcome Measures

Primary Outcome Measures

1. overall survival []

2. progression-free survival []

3. transplant-related mortality []

Secondary Outcome Measures

1. acute GVHD []

2. chronic GVHD []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00382759
• Other Study ID Numbers: 012000
• First Posted: Oct 2, 2006
• Last Update Posted: Aug 3, 2009
• Last Verified: Jul 1, 2009

• Additional relevant MeSH terms: Neoplasms; Hematologic Neoplasms

Study Results

No Results Posted as of Aug 3, 2009