A prospective observational study for a validation of National Institutes of Health criteria for late-acute and chronic GVHD (KSGCT1201 / NIH-GVHD STUDY)
Not Applicable
- Conditions
- Allogeneic hematopoietic stem cell transplantation
- Registration Number
- JPRN-UMIN000007793
- Lead Sponsor
- Kanto Study Group for Cell Therapy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Not provided
Exclusion Criteria
Patients without written informed consent.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate weather global severity of NIH-GVHD associates with GVHD specific survival and the time to immunosuppressant withdrawal.
- Secondary Outcome Measures
Name Time Method Evaluate the association of classification and global severity of NIH-GVHD with following parameters; Overall survival Evaluate the association of classification and global severity of NIH-GVHD with following parameters; Overall survival Non-relapse mortality Relapse rate Incidence of secondary malignancy Cumulative incidence of NIH-GVHD Distribution of organ specific severity Risk factor for the onset of NIH-GVHD Treatment outcome of NIH-GVHD