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Completed

NCT Number: NCT01135641

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

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.

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Key information

Conditions

Graft Versus Host Disease Graft vs Host Disease Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (≥18 years) who have received a first allogeneic stem cell transplantation for a hematological disease
  • Confirmed diagnosis of first episode of chronic GVHD requiring systemic immunosuppressive therapy. Chronic GVHD diagnosis is defined according to the NIH Working Group Consensus. Chronic GVHD diagnosis will be based on the evaluation of the severity of the different clinical manifestations including :
  • Ocular, oral and mucosal symptoms,
  • Performance status evaluation,
  • Pulmonary function evaluation,
  • Cutaneous evaluation measured by the percentage of extension of manifestations of liche-noid or sclerodermatous aspects, eventually confirmed with a biopsy whenever possible,
  • Evaluation of the musculoskeletal manifestations, especially the amplitude of the rele-vant articulations,
  • Evaluation of liver involvement (Total bilirubin, Transaminases, Phosphatase alcalines and Gamma GT).
  • Any source of hematopoietic stem cells is authorized.
  • Any category of conditioning regimen prior to allo-SCT is authorized.
  • Any type of stem cell donors is authorized.
  • Signed informed consent.
  • Any prior GVHD prophylaxis previously used is accepted.
  • Absence of contra-indications to the use of Rituximab.
  • Subjects affiliated with an appropriate social security system.
  • Women who are of childbearing potential must have a negative serum pregnancy test and agree to use a medically acceptable method of contraception throughout the study and for 3 months following the end of the study.

Exclusion criteria

  • Patient developing acute GVHD (whether early or "late onset" form)
  • A "limited" form of chronic GVHD not requiring systemic immunosuppressive therapy
  • Treatment with prednisone (or equivalent) at doses higher than 1 mg/kg/day at the time of enrollment.
  • GVHD occurring following donor lymphocytes infusion (DLI)
  • Not the first episode of chronic GVHD needing systemic immunosuppressive therapy
  • Neutropenia <500/µL
  • Second allogeneic stem cell transplant
  • Uncontrolled systemic infection which in the opinion of the investigator is associated with an increased risk of the patient's death within 1 month after the start of therapy
  • Severe neurological or psychiatric disorders
  • Denied informed consent
  • Pregnancy

Treatment and study plan

Rituximab

Drug

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.

Ciclosporine

Drug

Corticosteroids

Drug

Primary outcomes

  1. Response rate at 12 months

    Response rate (complete and partial remission) at 12 months after diagnosis of chronic GVHD and treatment with the combination of ciclosporine, prednisone and Rituximab as first line treatment.

Secondary outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability

    To spare patients from long-term use of corticosteroids (and of their long-term side effects)

  2. Treatment failure

    To document treatment failure-defined as initiation of another immunosuppressive agent

  3. Transplant-related mortality

    To decrease transplant-related mortality (TRM) of infectious and non-infectious origin

  4. Quality of life

    To improve quality of life parameters

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Phase II Study of First Line Treatment of Chronic Graft Versus Host Disease With the Association of Ciclosporine, Corticosteroids and Rituximab

Acronym: R-GVHD

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 3, 2010
Registry last updated
Apr 3, 2014

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.

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