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Completed

NCT Number: NCT00382759

Nonmyeloablative Stem Cell Transplant in Elderly

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

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Key information

Conditions

Hematological Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ospedale San Giovanni Battista

Torino, 10126, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stem Cell Transplant

Procedure

Primary outcomes

  1. overall survival

  2. progression-free survival

  3. transplant-related mortality

Secondary outcomes

  1. acute GVHD

  2. chronic GVHD

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera San Giovanni Battista

Other

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Oct 2, 2006
Registry last updated
Aug 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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