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Conditioning Regimen Before Infusion of Allogeneic Hematopoietic Stem Cells

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ClinicalTrials.gov Identifier: NCT00770523
Recruitment Status : Completed
First Posted : October 10, 2008
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:
Cooperative Study Group A for Hematology

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

Condition or disease
HEMATOLOGIC MALIGNANCIES

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
Actual Enrollment : 52 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Unrelated Donor Hematopoietic Stem Cell Transplantation After Nonmyeloablative Conditioning for Younger Patients With Hematologic Malignancies
Study Start Date : December 2003
Actual Primary Completion Date : March 2008
Actual Study Completion Date : December 2008



Primary Outcome Measures :
  1. treatment-related mortality and engraftment [ Time Frame: all cause mortality ]

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


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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770523


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Cooperative Study Group A for Hematology
Investigators
Principal Investigator: Kyoo-hyung Lee, doctor COSAH

Responsible Party: Yae-Eun Jang, COSAH
ClinicalTrials.gov Identifier: NCT00770523     History of Changes
Other Study ID Numbers: C-004
First Posted: October 10, 2008    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by Cooperative Study Group A for Hematology:
patients without comorbidity

Additional relevant MeSH terms:
Neoplasms