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Maintenance Obinutuzumab for Central Nervous System Lymphoma
Study Summary
This trial looks at whether obinutuzumab can help keep central nervous system lymphoma from coming back after initial treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 229 Patients • NCT02264574Trial Design
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Who is running the clinical trial?
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- I have had cancer before that might interfere with this study.I have tested positive for hepatitis B or C but may still qualify based on further testing.I am not pregnant or breastfeeding.You have allergies or strong reactions to any of the study medications.You have had serious allergic reactions to a specific type of medication called monoclonal antibodies.I am HIV positive.I received a live vaccine at least 4 weeks before joining the study.I finished my first cancer treatment less than 75 days ago and it worked.My lymphoma in the brain was confirmed by tests on my spinal fluid or a biopsy.I haven't had a serious infection or needed IV antibiotics in the last 4 weeks.I've had initial treatment with high-dose methotrexate for my cancer.I have had a brain MRI showing treatment response within the last 30 days.My lymphoma in the CSF or eye is in complete remission without steroids for 2 weeks.I had skin or cervical cancer treated to cure, or any cancer in remission for 2+ years without treatment.My kidneys work well enough to clear creatinine over 30 mL/min.I have non-Hodgkin lymphoma that has spread outside my brain and spinal cord.I can care for myself and perform daily activities.I am using or agree to use birth control during and after my treatment with obinutuzumab.I have not had major surgery in the last 4 weeks.
- Group 1: Arm I (obinutuzumab)
- Group 2: Arm II (observation)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA green-lighted Obinutuzumab for usage?
"Our research team has determined that obinutuzumab is likely safe, granting it a score of 2 as there have only been preliminary trials suggesting its safety rather than efficacy."
How many individuals have been chosen to participate in this clinical investigation?
"The sponsor, Genentech Inc., requires 60 participants that meet the study's eligibility criteria to execute it. Consequently, they are running this trial from two different locations: Providence Portland Medical Center in Cleveland, Ohio and Cleveland Clinic Cancer Center/Fairview Hospital in Hershey, Pennsylvania."
Is this experiment the inaugural of its kind?
"At the present moment, 100 live clinical trials for Obinutuzumab are underway in 46 countries and 948 cities. The first test was conducted by Genentech Inc. in 2014 with 40 participants across two phases of drug approval; since then, 181 additional tests have been completed."
Are there any prior trials that have been conducted pertaining to Obinutuzumab?
"Currently, there are 100 trials studying Obinutuzumab and 18 of those studies have advanced to Phase 3. La Jolla is the epicentre for these investigations but in total, 4852 research sites around the world are running experiments with this drug."
In what geographical areas is this research currently taking place?
"At this moment in time, 11 medical centres are recruiting patients for the trial. These sites include Cleveland, Hershey and Winston-Salem along with 8 other places. To reduce travel expenses associated with being a part of the study, it is advised to pick the clinic closest to your residence."
Are there vacancies for participants in this research endeavor?
"Affirmative. Clinicaltrials.gov documents indicate that this clinical research is presently enrolling patients, as it first appeared on July 12th 2016 and was recently updated on June 9th 2022. There are 11 sites recruiting 60 participants in total for the trial."
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