Conditioning Regimens for Patients With Severe Aplastic Anemia Transplanted With Marrow From an Unrelated Donor

This study has been completed.
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
University of California, Los Angeles
City of Hope National Medical Center
University of Utah
Oregon Health and Science University
Baylor University
Ohio State University
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00144729
First received: September 1, 2005
Last updated: April 28, 2008
Last verified: April 2008

September 1, 2005
April 28, 2008
May 1993
Not Provided
Sustained engraftment; survival
Same as current
Complete list of historical versions of study NCT00144729 on ClinicalTrials.gov Archive Site
Acute and chronic GVHD
Same as current
Not Provided
Not Provided
 
Conditioning Regimens for Patients With Severe Aplastic Anemia Transplanted With Marrow From an Unrelated Donor
Conditioning Regimens for Patients With Severe Aplastic Anemia Transplanted With Marrow From an Unrelated Donor

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anemia, Aplastic
Procedure: Bone marrow transplant
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
July 2007
Not Provided

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;
Both
up to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00144729
FHCRC 0800.01, NIH# HL36444-21, IRB# 3632
Not Provided
Not Provided
Fred Hutchinson Cancer Research Center
  • University of Minnesota - Clinical and Translational Science Institute
  • University of California, Los Angeles
  • City of Hope National Medical Center
  • University of Utah
  • Oregon Health and Science University
  • Baylor University
  • Ohio State University
Principal Investigator: Joachim Deeg, M.D. Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP