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

This study has been completed.
Sponsor:
Collaborator:
Agence de la Biomedecine
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00948727
First received: July 28, 2009
Last updated: September 30, 2009
Last verified: July 2009
History of Changes
  Purpose

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).


Condition Intervention Phase
Hematopoietic Stem Cell Transplantation
Graft Versus Host Disease
 Behavioral: Dose adaptation according to CN activity monitoring
Drug: Cyclosporine (CsA)
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • The primary end point is the acute grade II to IV GVHD-free survival 100 days after transplantation. [ Time Frame: 100 days after transplantation. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: January 2004
Study Completion Date: June 2008
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Dose adaptation according to CN activity monitoring
Drug: Cyclosporine (CsA)
Cyclosporine (CsA)
Other Name: Cyclosporine (CsA)

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.

  Eligibility

Ages Eligible for Study:   12 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948727

Locations
France
Chu Henri Mondor
Créteil, France, 94000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Agence de la Biomedecine
Investigators
Study Director: Sylvia Sanquer, Pharm.D. AP-HP, Hôpital Necker-Enfants Malades
  More Information

Publications:

Responsible Party: Thérèse NGOUE, Department Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00948727     History of Changes
Other Study ID Numbers: P021004
Study First Received: July 28, 2009
Last Updated: September 30, 2009
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013