Cyclosporine Dose Adjustment According to Calcineurin Activity After Allogeneic Hematopoietic Stem-cell Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

September 30, 2006

Study Completion Date

June 30, 2008

Conditions
Hematopoietic Stem Cell TransplantationGraft Versus Host Disease
Interventions
BEHAVIORAL

Dose adaptation according to CN activity monitoring

The protocol of the CALCICLO trial consisted in a CsA dose adaptation during the first 100 days following transplantation. This dose adaptation was performed according to both residual CsA blood and CN activity levels only if the safety of vital functions - especially renal, liver, and neurological - was preserved as assessed by clinical evaluations and laboratory analyses such as creatinine clearance higher than 40 ml/min, serum bilirubin lower than 40 µM and absence of neurological signs. According to the protocol, CsA blood levels and CN activity were measured concomitantly at least once a week from day 0 to day 15, twice a week from day 16 to day 35 and then once a week until day 100.

DRUG

Cyclosporine (CsA)

Cyclosporine (CsA)

Trial Locations (1)

94000

Chu Henri Mondor, Créteil

All Listed Sponsors
collaborator

Agence de La Biomédecine

OTHER_GOV

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT00948727 - Cyclosporine Dose Adjustment According to Calcineurin Activity After Allogeneic Hematopoietic Stem-cell Transplantation | Biotech Hunter | Biotech Hunter