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

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 2

Conditions

Graft Versus Host Disease

Hematopoietic Stem Cell Transplantation

Treatments

Behavioral: Dose adaptation according to CN activity monitoring

Drug: Cyclosporine (CsA)

Study type

Interventional

Funder types

Other

Identifiers

NCT00948727

P021004

Details and patient eligibility

About

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).

Full 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.

Enrollment

39 patients

Sex

All

Ages

12 to 85 years old

Volunteers

No Healthy Volunteers

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