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

• Sponsor: Fred Hutchinson Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00144729
• Collaborator: University of Minnesota (Other), University of California, Los Angeles (Other), City of Hope National Medical Center (Other), University of Utah (Other), Oregon Health and Science University (Other), Baylor University (Other), Ohio State University (Other)
• Enrollment: 85
• Location: 1
• Duration (Months): 170
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia, Aplastic	Procedure: Bone marrow transplant	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• 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
• Study Start Date: May 1, 1993
• Actual Study Completion Date: Jul 1, 2007

Outcome Measures

Primary Outcome Measures

1. Sustained engraftment; survival []

Secondary Outcome Measures

1. Acute and chronic GVHD []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance	Seattle	Washington	United States	98109

Sponsors and Collaborators

• Fred Hutchinson Cancer Center
• University of Minnesota
• 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 Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00144729
• Other Study ID Numbers: FHCRC 0800.01; NIH# HL36444-21; IRB# 3632
• First Posted: Sep 5, 2005
• Last Update Posted: Apr 30, 2008
• Last Verified: Apr 1, 2008

• Additional relevant MeSH terms: Anemia; Anemia, Aplastic

Study Results

No Results Posted as of Apr 30, 2008