OBJECTIVES: * Compare the efficacy of immunosuppressive treatment regimens with vs without mycophenolate mofetil in patients with newly diagnosed chronic graft-vs-host disease. * Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, double-blind, placebo-controlled, prospective, multicenter study. Patients are stratified according to organ involvement of chronic graft-versus-host disease (GVHD) (single organ vs multiple organs) and transplant center. Patients are randomized to 1 of 2 treatment arms. All patients receive usual therapy for chronic GVHD comprising oral prednisone twice daily and oral cyclosporine, oral tacrolimus or oral sirolimus twice daily until 2 weeks after the first evidence of improvement of symptoms of chronic GVHD. * Arm I: Patients receive oral mycophenolate mofetil twice daily. * Arm II: Patients receive oral placebo twice daily. In both arms administration of the study drug continues for 3 months after completion of prednisone and cyclosporine, tacrolimus or sirolimus in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 3 months. Patients are followed every 3 months for 3-5 years. PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 3 years.
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
are designated in this study
of being blinded to the placebo group