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 range
6 Months – 19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.