Conditioning Regimen Before Infusion of Allogeneic Hematopoietic Stem Cells

June 8, 2011 updated by: Cooperative Study Group A for Hematology

Unrelated Donor Hematopoietic Stem Cell Transplantation After Nonmyeloablative Conditioning for Younger Patients With Hematologic Malignancies

Unrelated Donor Hematopoietic Stem Cell Transplantation After Nonmyeloablative Conditioning for Younger Patients with Hematologic Malignancies.

Study Overview

Status

Completed

Conditions

Detailed Description

Primary end points are treatment-related mortality and engraftment. Secondary end points are regimen-related toxicities, graft-versus-host-disease, relapse, and overall survival.

Study Type

Observational

Enrollment (Actual)

52

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

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

15 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

acute leukemia chronic myelogenous leukemia myelodysplastic syndrome

Description

Inclusion Criteria:

-Patients should have an unrelated donor who is matched for HLA-A and -B by serology and for -DRB1 by molecular typing.

Exclusion Criteria:

  • Patients should not have major illness or organ failure
  • Patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
  • Patients must not be pregnant or lactating.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
treatment-related mortality and engraftment
Time Frame: all cause mortality
all cause mortality

Secondary Outcome Measures

Outcome Measure
Time Frame
regimen-related toxicities, graft-versus-host-disease, relapse, and overall survival.
Time Frame: Time point(s) at which outcome measure is assessed.
Time point(s) at which outcome measure is assessed.

Collaborators and Investigators

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

Sponsor

Cooperative Study Group A for Hematology

Investigators

  • Principal Investigator: Kyoo-hyung Lee, doctor, COSAH

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

December 1, 2003

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

October 5, 2008

First Submitted That Met QC Criteria

October 9, 2008

First Posted (Estimate)

October 10, 2008

Study Record Updates

Last Update Posted (Estimate)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-004

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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