Effectiveness of Rituximab in Pediatric OMS Patients. (NCT00244361) | Clinical Trial Compass
CompletedPhase 1/2
Effectiveness of Rituximab in Pediatric OMS Patients.
United States25 participantsStarted 2005-06
Plain-language summary
The purpose of this study is to reduce the symptoms of OMS by testing rituximab (Rituxan®), to remove B lymphocytes that make antibodies and trigger brain inflammation. Evidence suggests that autoimmune brain inflammation causes the symptoms of OMS. This study of blood and spinal fluid intends to find out what effect rituximab has on OMS and on the spinal fluid B-cells.
Rituximab targets and destroys B-cells, which make antibodies that can attack the brain and cause may OMS. It is infused through a vein over a period of several hours. Rituximab has been used widely and studied extensively since its approval in 1997 by the U.S. Food and Drug Administration (FDA) for non-Hodgkin's B-cell Lymphoma (NHL). Today, more than 300,000 patients have received rituximab, and it is part of more than 200 completed, ongoing, or planned clinical trials. Rituximab is not FDA-approved for OMS.
Who can participate
Age range6 Months – 19 Years
SexALL
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Inclusion Criteria:
* written consent from parents
* have symptomatic OMS
* have CSF B-cell expansion (\>1% B-cells)
* adequate renal function as indicated by normal BUN \[10-25 mg/dL\] and creatinine \[0.4-1.2 mg/dL\]
* adequate liver function, as indicated by up to 2x normal AST \[0-35 U/L\] and ALT \[0-35 U/L\].
* men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatment
Exclusion Criteria:
* treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (which ever is longer)
* receipt of a live vaccine within 4 weeks prior to enrollment
* previous treatment with Rituximab
* prior antibody therapy (does not include IVIg) within past 6 months
* history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* history of HIV (patients considered high risk will be screened)
* history of hepatitis B and/or hepatitis C (patients considered high risk will be screened)
* history of recurrent significant infection or history of recurrent bacterial infections
* known active bacterial, viral fungal mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks p…
What they're measuring
1
Determine the effectiveness & selectivity of rituximab at depleting CSF B-cells in OMS with intrathecal B-cell expansion. This requires CSF & blood lympocyte immunophenotyping prior to the first infusion & intervals for 1 year after the final infusion.
Trial details
NCT IDNCT00244361
SponsorNational Pediatric Neuroinflammation Organization, Inc.