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

This study has been completed.

Sponsor:

Collaborators:

University of Minnesota - Clinical and Translational Science Institute

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

First received: September 1, 2005

Last updated: April 28, 2008

Last verified: April 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 1, 2005

Last Updated Date

April 28, 2008

Start Date ^ICMJE

May 1993

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Sustained engraftment; survival

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00144729 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Acute and chronic GVHD

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Anemia, Aplastic

Intervention ^ICMJE

Procedure: Bone marrow transplant

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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;

Gender

Both

Ages

up to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00144729

Other Study ID Numbers ^ICMJE

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

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Fred Hutchinson Cancer Research Center

Collaborators ^ICMJE

University of Minnesota - Clinical and Translational Science Institute
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 ^ICMJE

Principal Investigator:

Joachim Deeg, M.D.

Fred Hutchinson Cancer Research Center

Information Provided By

Fred Hutchinson Cancer Research Center

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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