Anemia

General anemia

Clinical Trial: Conditioning Regimens for Patients with Severe Aplastic Anemia Transplanted with Marrow From an Unrelated Donor

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Purpose
Eligibility
Location and Contact Information
More Information

This study is currently recruiting patients.
Verified by Fred Hutchinson Cancer Research Center September 2005

Sponsors and Collaborators:	Fred Hutchinson Cancer Research 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
Information provided by:	Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:	NCT00144729

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 I Phase II

MedlinePlus related topics: Anemia

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment

Further Study Details:

Primary Outcomes: Sustained engraftment; survival
Secondary Outcomes: Acute and chronic GVHD
Expected Total Enrollment: 85

Study start: May 1993
Last follow-up: August 2005

Eligibility

Ages Eligible for Study: up to 55 Years, Genders Eligible for Study: Both

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 abnormalilities or myelodysplastic syndrome;

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00144729

Joachim Deeg, M.D. 206-667-5985 jdeeg@fhcrc.org

Washington
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, Washington, 98109, United States; Recruiting

Joachim Deeg, M.D. 206-667-5985 jdeeg@fhcrc.org

Study chairs or principal investigators

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

More Information

Study ID Numbers: FHCRC 0800.01; NIH# HL36444-21; IRB# 3632
Last Updated: September 2, 2005
Record first received: September 1, 2005
ClinicalTrials.gov Identifier: NCT00144729
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06

Source: ClinicalTrials.gov
Cache Date: September 7, 2005

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Conditioning Regimens for Patients with Severe Aplastic Anemia Transplanted with Marrow From an Unrelated Donor - Article

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Anemia

General anemia

Clinical Trial: Conditioning Regimens for Patients with Severe Aplastic Anemia Transplanted with Marrow From an Unrelated Donor

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Purpose

Eligibility

Location and Contact Information

More Information

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Conditioning Regimens for Patients with Severe Aplastic Anemia Transplanted with Marrow From an Unrelated Donor - Article

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General anemia

Clinical Trial: Conditioning Regimens for Patients with Severe Aplastic Anemia Transplanted with Marrow From an Unrelated Donor

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Purpose

Eligibility

Location and Contact Information

More Information

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