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

NCT00948727 | Completed Phase 2

• 1 other identifier: P021004
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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).

Conditions

Hematopoietic Stem Cell Transplantation; Graft Versus Host Disease

Outcome Measures

Primary Outcomes (1)

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

  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.

  100 days after transplantation

Study Arms (1)

Dose adjustment according CN activity

EXPERIMENTAL

Behavioral: Dose adaptation according to CN activity monitoring; Drug: Cyclosporine (CsA)

Interventions

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.

Dose adjustment according CN activity

Cyclosporine (CsA) DRUG

Cyclosporine (CsA)

Dose adjustment according CN activity

Eligibility Criteria

• Age: 12 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Agence de La Biomédecine: collaborator

Study Sites (1)

Chu Henri Mondor

Créteil, 94000, France

Location

Related Publications (1)

• 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. doi: 10.1097/01.tp.0000114612.55925.22.

  PMID: 15077026 BACKGROUND

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Sylvia Sanquer, Pharm.D.

  AP-HP, Hôpital Necker-Enfants Malades

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: July 29, 2009
• Study Start: January 1, 2004
• Primary Completion: September 1, 2006
• Study Completion: June 1, 2008
• Last Updated: October 1, 2009

Record last verified: 2009-07

Locations

FR (1)