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

Anemia, Aplastic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144729
• Other study ID #: FHCRC 0800.01
• Secondary ID: NIH# HL36444-21I
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 1, 2005
• Last updated: April 28, 2008
• Start date: May 1993
• Est. completion date: July 2007

Study information

• Verified date: April 2008
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 55 Years

Eligibility

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;

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Aplastic

Intervention

Procedure:
• Bone marrow transplant

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (8)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	Baylor University, City of Hope National Medical Center, Ohio State University, Oregon Health and Science University, University of California, Los Angeles, University of Minnesota - Clinical and Translational Science Institute, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained engraftment; survival
Secondary	Acute and chronic GVHD