Back to resultsConditioning Regimens for Patients With Severe Aplastic Anemia Transplanted With Marrow From an Unrelated Donor
Primary Purpose
Anemia, Aplastic
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bone marrow transplant
Sponsored by
About this trial
This is an interventional treatment trial for Anemia, Aplastic
Eligibility Criteria
Inclusion Criteria: Life-threatening marrow failure of nonmalignant etiology; failure to respond to the best available immunosuppressive treatment; lack of a HLA-identical family member Exclusion Criteria: Severe disease other than aplastic anemia that would severly limit the probability of survival during the graft procedure; HIV seropositive patients; clonal abnormalities or myelodysplastic syndrome;
Sites / Locations
- Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance
Outcomes
Primary Outcome Measures
Sustained engraftment; survival
Secondary Outcome Measures
Acute and chronic GVHD
Full Information
NCT ID
NCT00144729
First Posted
September 1, 2005
Last Updated
April 28, 2008
Sponsor
Fred Hutchinson Cancer Center
Collaborators
University of Minnesota, University of California, Los Angeles, City of Hope National Medical Center, University of Utah, Oregon Health and Science University, Baylor University, Ohio State University
1. Study Identification
Unique Protocol Identification Number
NCT00144729
Brief Title
Conditioning Regimens for Patients With Severe Aplastic Anemia Transplanted With Marrow From an Unrelated Donor
Official Title
Conditioning Regimens for Patients With Severe Aplastic Anemia Transplanted With Marrow From an Unrelated Donor
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
May 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
University of Minnesota, University of California, Los Angeles, City of Hope National Medical Center, University of Utah, Oregon Health and Science University, Baylor University, Ohio State University
4. Oversight
5. Study Description
Brief Summary
A single arm dose optimization study in which all patients are given a fixed dose of Cytoxan (4 x 50 mg/kg) plus ATG (3 x 30 mg/kg) and the TBI dose starting at 3 x 200 cGy is escalated or de-escalated dependent upon engraftment and toxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Aplastic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
85 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Bone marrow transplant
Primary Outcome Measure Information:
Title
Sustained engraftment; survival
Secondary Outcome Measure Information:
Title
Acute and chronic GVHD
10. Eligibility
Sex
All
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Life-threatening marrow failure of nonmalignant etiology;
failure to respond to the best available immunosuppressive treatment;
lack of a HLA-identical family member
Exclusion Criteria:
Severe disease other than aplastic anemia that would severly limit the probability of survival during the graft procedure;
HIV seropositive patients;
clonal abnormalities or myelodysplastic syndrome;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Deeg, M.D.
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Conditioning Regimens for Patients With Severe Aplastic Anemia Transplanted With Marrow From an Unrelated Donor
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