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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014