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Conditioning Regimen Before Infusion of Allogeneic Hematopoietic Stem Cells

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00770523
First Posted: October 10, 2008
Last Update Posted: June 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cooperative Study Group A for Hematology
  Purpose
Unrelated Donor Hematopoietic Stem Cell Transplantation After Nonmyeloablative Conditioning for Younger Patients with Hematologic Malignancies.

Condition Phase
HEMATOLOGIC MALIGNANCIES Phase 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: 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 ]

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. ]

Enrollment: 52
Study Start Date: December 2003
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

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
  More Information

Responsible Party: Yae-Eun Jang, COSAH
ClinicalTrials.gov Identifier: NCT00770523     History of Changes
Other Study ID Numbers: C-004
First Submitted: October 5, 2008
First Posted: October 10, 2008
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