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

Phase 1

Completed

• Conditions: Anemia, Aplastic

• Registration Number: NCT00144729
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1993-05
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-05
• Study Completion: 2007-07
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-28
• Last Update Posted: 2008-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sustained engraftment; survival

Secondary Outcome Measures

Name	Time	Method
Acute and chronic GVHD

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States