Mycophenolate Mofetil (MMF) for Treatment of Chronic Graft-versus-host Disease (GVHD)

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Mycophenolate mofetil added to immunosuppressive treatment regimens may be effective in treating newly diagnosed chronic graft-versus-host disease caused by stem cell transplantation. It is not yet known whether immunosuppressive treatment regimens are more effective with or without mycophenolate mofetil in treating chronic graft-versus-host disease.

PURPOSE: This randomized phase III trial is studying whether the addition of mycophenolate mofetil improves the efficacy of immunosuppressive treatment regimens in patients with newly diagnosed chronic graft-versus-host disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Martin, Paul
• Collaborator: National Cancer Institute (NCI)
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

Criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed chronic-graft-versus host disease (GVHD)

• Systemic immunosuppressive treatment indicated AND no contraindication to treatment with mycophenolate mofetil

• Has undergone prior transplantation with any type of donor, hematopoietic stem cell graft, or conditioning regimen

• No clinical, laboratory, or image-based evidence known to be present at the time of enrollment and indicating a high probability of subsequent recurrent or progressive disease

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

Hepatic

• Not specified

Renal

• Not specified

Pulmonary

• No known bronchiolitis obliterans as a manifestation of chronic GVHD

Immunologic

• No fungal infection without radiographic evidence of improvement during continued antifungal therapy

• No cytomegalovirus (CMV) pneumonia without major radiographic evidence of improvement

• No other CMV infection without reduction of antigenemia or viral load during continued antiviral therapy

• No active disseminated varicella zoster viral infection

• No known hypersensitivity or allergy to MMF

Gastrointestinal

• Able to tolerate oral medication

• No lactose-intolerant children who are too young to swallow capsules

• No frank blood from the rectum

• No melena

• No known gastrointestinal ulceration

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Female patients must use 2 forms of contraception 4 weeks prior to, during, and for 6 weeks after completion of study treatment

• Not hospitalized at time of enrollment

• No rare, hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT)

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• Not specified

Endocrine therapy

• Prior treatment with prednisone or equivalent allowed provided the dose was ≤ 1.0 mg/kg/day at the time of enrollment

• Concurrent systemic glucocorticoids allowed

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Prior mycophenolate mofetil (MMF) for prevention or treatment of acute GVHD allowed provided MMF was discontinued at least 2 weeks before the diagnosis of chronic GVHD was made

• No prior systemic treatment for chronic GVHD

• No prior treatment for chronic GVHD

• Concurrent antacids allowed provided there is at least a 2-hour interval before and after administration of MMF

• No other concurrent systemic immunosuppressive treatment except cyclosporine, tacrolimus or sirolimus