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Study of First Line Treatment of Chronic Graft Versus Host Disease With the Association of Ciclosporine, Corticosteroids and Rituximab (Protocol R-GVHD)

NCT01135641 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2014-04-03

No results posted yet for this study

Summary

The main objective of the study is to improve the response rate (complete and partial remission) at 12 months after diagnosis of chronic Chronic Graft Versus Host Disease (GVHD) and treatment with the combination of ciclosporine, prednisone and Rituximab as first line treatment.

Conditions

Interventions

DRUG

Rituximab

Patients will receive in addition to ciclosporine A and corticosteroids (prednisone) 1 mg/kg/day, Rituximab at 375 mg/m²/infusion once a week for 4 consecutive weeks.

DRUG

Ciclosporine

DRUG

Corticosteroids

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Mohamad MOHTY, Profesor · Hôpital Saint-Antoine (Paris)

  • Noël MILPIED, Profesor · University Hospital, Bordeaux

  • Mauricette MICHALLET, Profesor · Hospices Civils de Lyon

  • Karin BILGER, Doctor · CHRU de Strasbourg

  • Oumédaly REMAN, Doctor · CHRU de Caen

  • Ibrahim YAKOUB-AGHA, Profesor · CHRU de Lille

  • Didier BLAISE, Profesor · Institut Paoli-Calmettes

  • Patrice CEBALLOS, Doctor · CHU de Montpellier

  • Patrice CHEVALLIER, Doctor · Nantes University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01135641 on ClinicalTrials.gov