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

April 28, 2008 updated by: Fred Hutchinson Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

85

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Sustained engraftment; survival

Secondary Outcome Measures

Outcome Measure
Acute and chronic GVHD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

University of California, Los Angeles
Oregon Health and Science University
Ohio State University
University of Minnesota
University of Utah
Baylor University
City of Hope National Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1993

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

April 30, 2008

Last Update Submitted That Met QC Criteria

April 28, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FHCRC 0800.01
  • NIH# HL36444-21
  • IRB# 3632

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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