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Stem Cell Transplant From Matched Unrelated or Partially Matched Related Donors

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ClinicalTrials.gov Identifier: NCT00186225
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
To evaluate the use of unrelated donors for hematopoietic cell transplantation in the treatment of hematologic and lymphoid malignancies.

Condition or disease Intervention/treatment Phase
Blood Cancer Blood and Marrow Transplant (BMT) Procedure: ablative allogeneic hematopoietic cell transplantation Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : November 1989
Actual Primary Completion Date : June 2007
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. oxicity and efficacy of TBI and cyclophosphamide as preparation for hematopoietic cell transplantation from partially matched and unrelated donors.

Secondary Outcome Measures :
  1. Overall Survival
  2. Event Free Survival

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   4 Weeks to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- acute leukemia

  • chronic leukemia
  • lymphoblastic lymphoma
  • MDS
  • MPS Exclusion Criteria:- organ dysfunction
  • HIV positive
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00186225


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Laura Johnston Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00186225    
Other Study ID Numbers: IRB-13390
75268 ( Other Identifier: Old IRB number )
BMT22 ( Other Identifier: OnCore )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases