Conditioning Regimen Before Infusion of Allogeneic Hematopoietic Stem Cells

This study is currently recruiting participants.

Verified by Cooperative Study Group A for Hematology, October 2008

First Received: October 5, 2008 Last Updated: October 9, 2008 History of Changes

Sponsored by:	Cooperative Study Group A for Hematology
Information provided by:	Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:	NCT00770523

Purpose

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

Condition	Phase
Hematologic Malignancies	Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Unrelated Donor Hematopoietic Stem Cell Transplantation After Nonmyeloablative Conditioning for Younger Patients With Hematologic Malignancies

Further study details as provided by Cooperative Study Group A for Hematology:

Primary Outcome Measures:

treatment-related mortality and engraftment [ Time Frame: all cause mortality ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

regimen-related toxicities, graft-versus-host-disease, relapse, and overall survival. [ Time Frame: Time point(s) at which outcome measure is assessed. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	52
Study Start Date:	December 2003
Estimated Study Completion Date:	December 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	15 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

acute leukemia chronic myelogenous leukemia myelodysplastic syndrome

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770523

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Yae-Eun Jang, Nurse 82-2-3010-7290 redpin75@paran.com
Principal Investigator: Hyoo-hyung Lee, Doctor

Sponsors and Collaborators

Cooperative Study Group A for Hematology

Investigators

Principal Investigator:

Kyoo-hyung Lee, doctor

COSAH

More Information

No publications provided

Responsible Party:	COSAH ( Yae-Eun Jang )
Study ID Numbers:	C-004
Study First Received:	October 5, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00770523 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Cooperative Study Group A for Hematology:

patients without comorbidity

Study placed in the following topic categories:

Hematologic Neoplasms
Hematologic Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Hematologic Neoplasms
Hematologic Diseases

ClinicalTrials.gov processed this record on May 06, 2009