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

Phase 2

Completed

• Conditions: Hematopoietic Stem Cell Transplantation; Graft Versus Host Disease
• Interventions: Behavioral: Dose adaptation according to CN activity monitoring; Drug: Cyclosporine (CsA)

• Registration Number: NCT00948727
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 disease (GVHD).

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 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 Timeline

• Study Start: 2004-01
• Primary Completion: 2006-09
• Study Completion: 2008-06
• Status Verified: 2009-07
• Study First Submitted: 2009-07-28
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-29
• Last Update Submitted: 2009-09-30
• Last Update Posted: 2009-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Patients were between the age of 12 and 60 years
• Patients planned to receive an allogeneic HSCT following a myeloablative conditioning regimen

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose adjustment according CN activity	Dose adaptation according to CN activity monitoring	-
Dose adjustment according CN activity	Cyclosporine (CsA)	-

Primary Outcome Measures

Name	Time	Method
The primary end point is the acute grade II to IV GVHD-free survival 100 days after transplantation.	100 days after transplantation.

Secondary Outcome Measures

Name	Time	Method
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.	100 days after transplantation

Trial Locations

Locations (1)

Chu Henri Mondor; 🇫🇷 Créteil, France