Myfortic - Treatment for Extensive cGvHD - Full Text View

Sponsors and Collaborators:	European Group for Blood and Marrow Transplantation Novartis
Information provided by:	European Group for Blood and Marrow Transplantation
ClinicalTrials.gov Identifier:	NCT00298324

Purpose

The purpose of this study is to determine whether the response to treatment for extensive chronic Graft versus Host Disease (cGvHD)is improved with the addition of myfortic alongside cyclosporine A and prednisone, compared to the reference treatment of cyclosporine A and prednisone alone.

Condition	Intervention	Phase
Graft vs Host Disease	Drug: Myfortic	Phase III

Drug Information available for: Cyclosporin Cyclosporine Mycophenolic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by European Group for Blood and Marrow Transplantation:

Primary Outcome Measures:

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. [ Time Frame: 1 year ]

Secondary Outcome Measures:

The hazard rates of efficacy success between the two arms. Loss of donor chimerism or recurrent malignancy before secondary systemic therapy and before discontinuation of all immunosuppressive meds will be treated as competing risks. [ Time Frame: 1 year ]
efficacy failure, and treatment failure defined as efficacy failure or premature discontinuation of study-drug administration due to toxicity [ Time Frame: 1 year ]
survival without recurrent malignancy [ Time Frame: 1 year ]
Overall survival [ Time Frame: 1 year ]
cumulative incidence of secondary systemic treatment for cGvHD before recurrent malignancy [ Time Frame: 1 year ]
the cumulative incidence of death without recurrent or malignancy [ Time Frame: 1 year ]

Estimated Enrollment:	200
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2008

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298324

Contacts

Contact: Gérard Socié	+33.1.42.49.98.24	gerard.socie@paris7.jussieu.fr
Contact: Roisín Cinnéide	+44 20 7380 9038	r.cinneide@ucl.ac.uk

Locations

France
Hopital St. Louis	Recruiting
Paris, France, 75475
Contact: Gérard Socié 0033 1 42 499824 gerard.socie@paris7.jussieu.fr>
Principal Investigator: Gérard Socié
Germany
University Regensburg	Not yet recruiting
Regensburg, Germany, 93042
Contact: Ernst Holler 0049-941-944-5542 ernst.holler@klinik.uni-regensburg.de
Principal Investigator: Ernst Holler
Italy
Ospedale San Martino	Not yet recruiting
Genova, Italy, 16132
Contact: Andrea Bacigalupo 0039-010-355-469 andrea.bacigalupo@hsanmartino.liguria.it
Principal Investigator: Andrea Bacigalupo
Netherlands
University Hospital	Not yet recruiting
Maastricht, Netherlands, 6202
Contact: Harry Schouten 0031-43-3-877025 h.schouten@intmed.unimaas.nl
Principal Investigator: Harry Schouten
Spain
Hospital Clínico Universitario	Not yet recruiting
Valencia, Spain, 46010
Contact: Carlos Solano carlos.solano@uv.esHospital Clínico Universitario
Principal Investigator: Carlos Solano
Sweden
Karolinska University Hospital	Not yet recruiting
Huddinge, Sweden, 141 86
Contact: Hans Hägglund 0046-8-585-800-00 Hans.Hagglund@ki.se
Principal Investigator: Hans Hägglund
Switzerland
University Hospital	Not yet recruiting
Basel, Switzerland, 4031
Contact: André Tichelli 0041 61 265 4254 tichelli@datacomm.ch
Principal Investigator: André Tichelli
Turkey
University Faculty of Medicine	Not yet recruiting
Ankara, Turkey, 06260
Contact: Mutlu Arat 0090 312 595 7098 arat@medicine.ankara.edu.tr
Principal Investigator: Mutlu Arat

Sponsors and Collaborators

European Group for Blood and Marrow Transplantation

Novartis

Investigators

Study Chair:

Gérard Socié

Hôptial St Louis, Paris

More Information

sponsor's website This link exits the ClinicalTrials.gov site

Study ID Numbers:	EudraCT 2005-006178-86, EBMT-LE-0601
Study First Received:	March 1, 2006
Last Updated:	May 9, 2007
ClinicalTrials.gov Identifier:	NCT00298324
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by European Group for Blood and Marrow Transplantation:

GvHD
graft versus host disease
extensive
myfortic

Study placed in the following topic categories:

Cyclosporine
Graft versus host disease
Mycophenolic Acid

Graft vs Host Disease
Cyclosporins
Homologous wasting disease

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009