Stem Cell Transplant From Matched Unrelated or Partially Matched Related Donors
Primary Purpose
Blood Cancer, Blood and Marrow Transplant (BMT)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ablative allogeneic hematopoietic cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Blood Cancer
Eligibility Criteria
Inclusion Criteria:- acute leukemia chronic leukemia lymphoblastic lymphoma MDS MPS Exclusion Criteria:- organ dysfunction HIV positive
Sites / Locations
- Stanford University School of Medicine
Outcomes
Primary Outcome Measures
oxicity and efficacy of TBI and cyclophosphamide as preparation for hematopoietic cell transplantation from partially matched and unrelated donors.
Secondary Outcome Measures
Overall Survival
Event Free Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00186225
Brief Title
Stem Cell Transplant From Matched Unrelated or Partially Matched Related Donors
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 Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 1989 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
Brief Summary
To evaluate the use of unrelated donors for hematopoietic cell transplantation in the treatment of hematologic and lymphoid malignancies.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Cancer, Blood and Marrow Transplant (BMT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
ablative allogeneic hematopoietic cell transplantation
Primary Outcome Measure Information:
Title
oxicity and efficacy of TBI and cyclophosphamide as preparation for hematopoietic cell transplantation from partially matched and unrelated donors.
Secondary Outcome Measure Information:
Title
Overall Survival
Title
Event Free Survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- acute leukemia
chronic leukemia
lymphoblastic lymphoma
MDS
MPS Exclusion Criteria:- organ dysfunction
HIV positive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Johnston
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
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Stem Cell Transplant From Matched Unrelated or Partially Matched Related Donors
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