Nonmyeloablative Stem Cell Transplant in Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00382759
Recruitment Status : Completed
First Posted : October 2, 2006
Last Update Posted : August 3, 2009
Information provided by:
Azienda Ospedaliera San Giovanni Battista

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 Type : Interventional  (Clinical Trial)
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 : March 2000
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Primary Outcome Measures :
  1. overall survival
  2. progression-free survival
  3. transplant-related mortality

Secondary Outcome Measures :
  1. acute GVHD
  2. chronic GVHD

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00382759     History of Changes
Other Study ID Numbers: 012000
First Posted: October 2, 2006    Key Record Dates
Last Update Posted: August 3, 2009
Last Verified: July 2009

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