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NCT00089141 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
TERMINATED
Registry last update
2013-05-03

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy

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outcome · POSTED

Definitive Absence of Efficacy Success

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outcome · POSTED

Open Label Systemic Treatment Because of Inadequate Response to Primary Therapy

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outcome · POSTED

Bronchiolitis Obliterans

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outcome · POSTED

Recurrent Malignancy

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outcome · POSTED

Non-relapse Mortality

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outcome · POSTED

Death or Recurrent Malignancy

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outcome · POSTED

Death

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outcome · POSTED

Withdrawal of Prednisone

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outcome · POSTED

End of Systemic Treatment

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
4 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive oral mycophenolate mofetil twice daily.
    intervention Names
    1. Drug: mycophenolate mofetil
    label
    Mycophenolate mofetil
    type
    ACTIVE_COMPARATOR
  2. description
    Patients receive oral placebo twice daily
    intervention Names
    1. Drug: placebo
    label
    Placebo
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Mycophenolate mofetil
    description
    Given orally
    name
    mycophenolate mofetil
    other Names
    1. CellCept
    type
    DRUG
  2. arm Group Labels
    1. Placebo
    description
    Given orally
    name
    placebo
    other Names
    1. Control
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
QUADRUPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
  4. OUTCOMES_ASSESSOR
primary Purpose
TREATMENT
Enrollment
count
151
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Withdrawal of all systemic immunosuppressive treatment after resolution of chronic GVHD, before death or onset of recurrent malignancy
    measure
    Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy
    time Frame
    2 years
secondary Outcomes
  1. description
    Administration of secondary systemic therapy for chronic GVHD, death during primary therapy, or onset of recurrent malignancy or bronchiolitis obliterans during primary therapy
    measure
    Definitive Absence of Efficacy Success
    time Frame
    2 years
  2. description
    Administration of any systemic therapy other than the immunosuppressive agents used for initial treatment, because of persistent or progressive chronic graft-versus-host disease
    measure
    Open Label Systemic Treatment Because of Inadequate Response to Primary Therapy
    time Frame
    2 years
  3. description
    Development of bronchiolitis obliterans during treatment
    measure
    Bronchiolitis Obliterans
    time Frame
    within 4 years
  4. description
    Development of recurrent malignancy after enrollment in the study
    measure
    Recurrent Malignancy
    time Frame
    within 4 years
  5. description
    Death without prior development of recurrent malignancy
    measure
    Non-relapse Mortality
    time Frame
    within 4 years
  6. description
    Death due to any cause or development of recurrent malignancy at any time after enrollment
    measure
    Death or Recurrent Malignancy
    time Frame
    within 4 years
  7. description
    Death from any cause after enrollment in the study
    measure
    Death
    time Frame
    within 4 years
  8. description
    Withdrawal of treatment with prednisone after improvement or resolution of chronic GVHD
    measure
    Withdrawal of Prednisone
    time Frame
    within 4 years
  9. description
    Withdrawal of all immunosuppressive treatment without recurrent malignancy
    measure
    End of Systemic Treatment
    time Frame
    within 4 years
Full study description
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 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.
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 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.
Source references
references
  1. citation
    Martin PJ, Storer BE, Rowley SD, Flowers ME, Lee SJ, Carpenter PA, Wingard JR, Shaughnessy PJ, DeVetten MP, Jagasia M, Fay JW, van Besien K, Gupta V, Kitko C, Johnston LJ, Maziarz RT, Arora M, Jacobson PA, Weisdorf D. Evaluation of mycophenolate mofetil for initial treatment of chronic graft-versus-host disease. Blood. 2009 May 21;113(21):5074-82. doi: 10.1182/blood-2009-02-202937. Epub 2009 Mar 6.
    pmid
    19270260
    type
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Source notices and limitations
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      source kind
      ctgov_condition_query
      source record id
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      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      890356db7dc15a91acd83613ca18fb2fad2592bd7836551ec367a038e7de14ff

    Preserved source evidence · Not medical advice