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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00948727
First Posted: July 29, 2009
Last Update Posted: October 1, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agence de La Biomédecine
Information provided by:
Assistance Publique - Hôpitaux de Paris
July 28, 2009
July 29, 2009
October 1, 2009
January 2004
September 2006   (Final data collection date for primary outcome measure)
The primary end point is the acute grade II to IV GVHD-free survival 100 days after transplantation. [ Time Frame: 100 days after transplantation. ]
Same as current
Complete list of historical versions of study NCT00948727 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Cyclosporine Dose Adjustment According to Calcineurin Activity After Allogeneic Hematopoietic Stem-cell Transplantation
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
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).

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Hematopoietic Stem Cell Transplantation
  • Graft Versus Host Disease
  • 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)
Experimental: Dose adjustment according CN activity
Interventions:
  • Behavioral: Dose adaptation according to CN activity monitoring
  • Drug: Cyclosporine (CsA)
Sanquer S, Schwarzinger M, Maury S, Yakouben K, Rafi H, Pautas C, Kuentz M, Barouki R, Cordonnier C. Calcineurin activity as a functional index of immunosuppression after allogeneic stem-cell transplantation. Transplantation. 2004 Mar 27;77(6):854-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
June 2008
September 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 85 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00948727
P021004
No
Not Provided
Not Provided
Thérèse NGOUE, Department Clinical Research of developpement
Assistance Publique - Hôpitaux de Paris
Agence de La Biomédecine
Study Director: Sylvia Sanquer, Pharm.D. AP-HP, Hôpital Necker-Enfants Malades
Assistance Publique - Hôpitaux de Paris
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP