Myfortic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Graft vs Host Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Patients in this arm will receive Myfortic + Prednisone + Cyclosporine

Group Type ACTIVE_COMPARATOR

Myfortic

Intervention Type DRUG

1440mg twice daily

Standard Care/ Placebo

In this arm patients will receive Prednisone + Cyclosporine + Placebo or Prednisone + Cyclosporine

Group Type OTHER

Prednisone and Cyclosporine

Intervention Type DRUG

Prednisone and Cyclosporine given according to protocol. The drugs are tapered according to patient response

Interventions

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Myfortic

1440mg twice daily

Intervention Type DRUG

Prednisone and Cyclosporine

Prednisone and Cyclosporine given according to protocol. The drugs are tapered according to patient response

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No