Cyclosporine Dose Adjustment According to Calcineurin Activity After Allogeneic Hematopoietic Stem-cell Transplantation (CALCICLO)
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|ClinicalTrials.gov Identifier: NCT00948727|
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : October 1, 2009
|Condition or disease||Intervention/treatment||Phase|
|Hematopoietic Stem Cell Transplantation Graft Versus Host Disease||Behavioral: Dose adaptation according to CN activity monitoring Drug: Cyclosporine (CsA)||Phase 2|
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 immunosuppressive therapy with calcineurin inhibitors.
This proof-of-concept trial is aiming at evaluating CALCIneurin activity as a monitoring biomarker of efficacy of cyCLOsporine - (CALCICLO) - for the prophylaxis of acute GVHD. Our aim is to assess whether a longitudinal monitoring of CN activity would permit to adapt and optimize the dose of CsA that would prevent the onset of severe acute GVHD, yet still maintaining an acceptable tolerability profile.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reduction of Acute and Chronic Graft-versus-host Disease After Allogeneic Hematopoietic Stem-cell Transplantation by Adapting Cyclosporine Doses According to Calcineurin Activity : a Proof-of-concept Trial|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||June 2008|
|Experimental: Dose adjustment according CN activity||
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)
- The primary end point is the acute grade II to IV GVHD-free survival 100 days after transplantation. [ Time Frame: 100 days after transplantation. ]
- Safety was a secondary endpoint. It was assessed through clinical assessments including vital signs, creatinine clearance, the presence or not of neurological signs evocative of, or consistent with CsA toxicity, creatinine clearance and serum bilirubin. [ Time Frame: 100 days after transplantation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948727
|Chu Henri Mondor|
|Créteil, France, 94000|
|Study Director:||Sylvia Sanquer, Pharm.D.||AP-HP, Hôpital Necker-Enfants Malades|