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

NCT ID: NCT00144729

Last Updated: 2008-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-05-31

Study Completion Date

2007-07-31

Brief Summary

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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

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Conditions

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Anemia, Aplastic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bone marrow transplant

Intervention Type PROCEDURE

Eligibility Criteria

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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;
Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

University of Minnesota

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role collaborator

City of Hope National Medical Center

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role collaborator

Baylor University

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

Principal Investigators

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Joachim Deeg, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

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Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NIH# HL36444-21

Identifier Type: -

Identifier Source: secondary_id

IRB# 3632

Identifier Type: -

Identifier Source: secondary_id

FHCRC 0800.01

Identifier Type: -

Identifier Source: org_study_id