Status:
TERMINATED
Mycophenolate Mofetil (MMF) for Treatment of Chronic Graft-versus-host Disease (GVHD)
Lead Sponsor:
Martin, Paul
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cancer
Eligibility:
All Genders
4+ years
Phase:
PHASE3
Brief 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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00089141
Start Date
May 1 2004
End Date
September 1 2008
Last Update
May 3 2013
Active Locations (16)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
2
Stanford Cancer Center
Stanford, California, United States, 94305-5824
3
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-100277
4
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470