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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00144729
First Posted: September 5, 2005
Last Update Posted: April 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
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.

Condition Intervention Phase
Anemia, Aplastic Procedure: Bone marrow transplant Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conditioning Regimens for Patients With Severe Aplastic Anemia Transplanted With Marrow From an Unrelated Donor

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Sustained engraftment; survival

Secondary Outcome Measures:
  • Acute and chronic GVHD

Estimated Enrollment: 85
Study Start Date: May 1993
Study Completion Date: July 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
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): NCT00144729


Locations
United States, Washington
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
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
Investigators
Principal Investigator: Joachim Deeg, M.D. Fred Hutchinson Cancer Research Center
  More Information

ClinicalTrials.gov Identifier: NCT00144729     History of Changes
Other Study ID Numbers: FHCRC 0800.01
NIH# HL36444-21
IRB# 3632
First Submitted: September 1, 2005
First Posted: September 5, 2005
Last Update Posted: April 30, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Anemia
Anemia, Aplastic
Hematologic Diseases
Bone Marrow Diseases