Status:
COMPLETED
Cyclosporine Dose Adjustment According to Calcineurin Activity After Allogeneic Hematopoietic Stem-cell Transplantation
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Agence de La Biomédecine
Conditions:
Hematopoietic Stem Cell Transplantation
Graft Versus Host Disease
Eligibility:
All Genders
12-85 years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to assess whether an adaptation of cyclosporine (CsA) dose according to a longitudinal calcineurin (CN) activity monitoring would prevent the onset of graft-versus-host di...
Detailed Description
Our previous studies established a correlation between increased calcineurin (CN) activity and the risk of developing severe acute GVHD in allogeneic stem cell transplant recipients receiving immunosu...
Eligibility Criteria
Inclusion
- Patients were between the age of 12 and 60 years
- Patients planned to receive an allogeneic HSCT following a myeloablative conditioning regimen
Exclusion
- Transplant from a syngeneic donor
- Evidence of refractory disease
- Nonmyeloablative conditioning
- Any participation to a study with a new investigational drug within the previous 3 months
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00948727
Start Date
January 1 2004
End Date
June 1 2008
Last Update
October 1 2009
Active Locations (1)
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1
Chu Henri Mondor
Créteil, France, 94000