A Randomized Double Blinded Placebo-Controlled Phase III Trial Comparing Cyclosporine Plus Steroids With or Without Myfortic as Primary Treatment for Extensive Chronic Graft Versus Host Disease
18 Years
60 Years
Both
Graft vs Host Disease
Trial Information
A Randomized Double Blinded Placebo-Controlled Phase III Trial Comparing Cyclosporine Plus Steroids With or Without Myfortic as Primary Treatment for Extensive Chronic Graft Versus Host Disease
This clinical trial is a European, multi-center, randomized, double blinded
placebo-controlled trial comparing CsA+PDN+MPA versus the reference treatment of CsA+PDN
alone + placebo, in patients with extensive chronic GvHD. Randomization will be stratified
according to:
- Platelet number (low versus high risk)
- Source of transplantable cells (marrow versus PBSC versus cord blood)
Patients not in progression at 6 weeks post randomization (progression defined as primary
failure) will be evaluated for remission (complete or partial) at 3, 6, 9, & 12 months post
randomization
Inclusion Criteria:
- Age 18 - 60
- Any primary diagnosis requiring treatment by hematopoietic stem cell transplantation
- Recipient of a single allogeneic stem cell transplant (bone marrow or peripheral
blood stem cells, or cord blood) minimum 80 days ago
- Received a graft from a related or an unrelated donor
- Conditioning regimen: Myeloablative or non-myeloablative
- Patients suffering a first episode of extensive chronic GvHD, without recurrent
disease
- The diagnosis of chronic GvHD requires the following:
- Distinction from acute GvHD
- Presence of at least one diagnostic clinical sign of chronic GvHD or presence of
at least one distinctive sign confirmed by pertinent biopsy or other relevant
diagnostic tests
- Exclusion of other possible diagnoses
- Receiving a standard prophylaxis regimen for acute GvHD: CsA plus methotrexate, or
CSA+MMF for NMA, or a T-cell depleted transplant
- Patient gives written informed consent prior to randomization
Exclusion Criteria:
- Patient age less than 18 years or over 60 years.
- GvHD prophylaxis by tacrolimus plus methotrexate
- Delayed onset acute GvHD following NMA or DLI
- Second allogeneic stem cell transplant
- Not the first episode of chronic GvHD needing systemic immunosuppressive therapy.
- Limited chronic GvHD (Seattle criteria, see Appendix 1)
- Uncontrolled systemic infection which in the opinion of the investigator is
associated with an increased risk of the patient's death within 1 week of
randomization
- In the opinion of the investigator, if the patient has significant medical or
psychosocial problems or unstable disease status
- Pregnant or lactating females
- Known hypersensitivity to mycophenolic acid
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
To test whether the addition of Myfortic improves the efficacy of prednisone plus cyclosporine for treatment of newly diagnosed chronic GvHD, as defined by the proportion of patients with efficacy success at 1 year after enrollment.
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Gérard Socié
Investigator Role:
Study Chair
Investigator Affiliation:
Hôptial St Louis, Paris
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
EudraCT 2005-006178-86
NCT ID:
NCT00298324
Start Date:
September 2006
Completion Date:
November 2010
Related Keywords:
- Graft Vs Host Disease
- GvHD
- graft versus host disease
- extensive
- myfortic
- Graft vs Host Disease
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