Trial Information
Unrelated Donor Hematopoietic Stem Cell Transplantation After Nonmyeloablative Conditioning for Younger Patients With Hematologic Malignancies
Primary end points are treatment-related mortality and engraftment. Secondary end points are
regimen-related toxicities, graft-versus-host-disease, relapse, and overall survival.
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.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
treatment-related mortality and engraftment
Outcome Time Frame:
all cause mortality
Safety Issue:
No
Principal Investigator
Kyoo-hyung Lee, doctor
Investigator Role:
Principal Investigator
Investigator Affiliation:
COSAH
Authority:
Korea: Food and Drug Administration
Study ID:
C-004
NCT ID:
NCT00770523
Start Date:
December 2003
Completion Date:
December 2008
Related Keywords:
- Hematologic Malignancies
- patients without comorbidity
- Neoplasms
- Hematologic Neoplasms