Skip to main content
OpenTrials
Completed

NCT Number: NCT00948727

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hematopoietic Stem Cell Transplantation Graft Versus Host Disease Graft vs Host Disease Immune System Diseases

Age range

12 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chu Henri Mondor

Créteil, 94000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dose adaptation according to CN activity monitoring

Behavioral

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.

Cyclosporine (CsA)

Drug

Cyclosporine (CsA)

Primary outcomes

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

    Time frame: 100 days after transplantation.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Agence de La Biomédecine

Registry information

Official study 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

Acronym: CALCICLO

Important dates

Study start
2004
Primary completion
2006
Study completion
2008
First posted
Jul 29, 2009
Registry last updated
Oct 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.