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Stem Cell Transplant From Matched Unrelated or Partially Matched Related Donors

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186225
First received: September 13, 2005
Last updated: July 23, 2010
Last verified: July 2010
History of Changes
  Purpose

To evaluate the use of unrelated donors for hematopoietic cell transplantation in the treatment of hematologic and lymphoid malignancies.


Condition Intervention
Blood Cancer
Blood and Marrow Transplant (BMT)
 Procedure: ablative allogeneic hematopoietic cell transplantation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stem Cell Transplantation From Matched Unrelated or Partially Matched Related Donors Using a Preparatory Regimen Consisting of Fractionated Total Body Irradiation (FTBI) and Cyclophosphamide (CY)

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • oxicity and efficacy of TBI and cyclophosphamide as preparation for hematopoietic cell transplantation from partially matched and unrelated donors. [ Time Frame: unknown ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • Event Free Survival [ Time Frame: unknown ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: November 1989
Study Completion Date: May 2010
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Stem Cell Transplantation from Matched Unrelated or Partially Matched Related Donors Using a Preparatory Regimen Consisting of Fractionated Total Body Irradiation (FTBI) and Cyclophosphamide (CY). To administer high dose radio-chemotherapy followed by stem cell transplantation from a matched unrelated donor or a partially matched related donor.

  Eligibility

Ages Eligible for Study:   up to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- acute leukemia

  • chronic leukemia
  • lymphoblastic lymphoma
  • MDS
  • MPS

Exclusion Criteria:- organ dysfunction

- HIV positive

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00186225

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Laura Johnston Stanford University
  More Information

No publications provided

Responsible Party: Laura Johnston, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186225     History of Changes
Other Study ID Numbers: BMT22, 75268, BMT22
Study First Received: September 13, 2005
Last Updated: July 23, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013