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

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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

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.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Sustained engraftment; survival

Secondary Outcome

 Acute and chronic GVHD

Condition

Anemia, Aplastic

Intervention

Bone marrow transplant


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

85

Start Date

May 1993

Completion Date

July 2007


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;
      

Gender

All

Ages

N/A - 55 Years

Accepts Healthy Volunteers

No

Contacts

Joachim Deeg, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00144729

Organization ID

FHCRC 0800.01

Secondary IDs

NIH# HL36444-21


Study Sponsor

Fred Hutchinson Cancer Research Center

Collaborators

 University of Minnesota

Study Sponsor

Joachim Deeg, M.D., Principal Investigator, Fred Hutchinson Cancer Research Center


Verification Date

April 2008