Conditioning Regimen Before Infusion of Allogeneic Hematopoietic Stem Cells

This study has been completed.
Sponsor:
Information provided by:
Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:
NCT00770523
First received: October 5, 2008
Last updated: June 8, 2011
Last verified: June 2011
  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

Resource links provided by NLM:


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 ]

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

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
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

No publications provided

Responsible Party: Yae-Eun Jang, COSAH
ClinicalTrials.gov Identifier: NCT00770523     History of Changes
Other Study ID Numbers: C-004
Study First Received: October 5, 2008
Last Updated: June 8, 2011
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014