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Nonmyeloablative Stem Cell Transplant in Elderly

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III, Phase II Treatment Active Over 60 Other 012000
NCT00382759

Trial Description

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

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

michele falda, md

Principal Investigator

michele falda, MD		Ph: 0116335359
		Email: mfalda@molinette.piemonte.it

Trial Sites

Italy

torino

Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

michele falda, md Ph: 0116335359

Email: mfalda@molinette.piemonte.it

michele falda, md Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00382759
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.