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Ofatumumab + Bendamustine for Mantle Cell Lymphoma
Study Summary
This trial is being done to study the effects of two drugs, Ofatumumab and Bendamustine, on Mantle Cell Lymphoma.
- Mantle Cell Lymphoma
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Could you elaborate on any prior investigations involving the combination of Ofatumumab and Bendamustine?
"Ofatumumab + Bendamustine was first examined in 2010 at the National Institutes of Health Clinical Centre, 9000 Rockville Pike. 71 completed trials have been administered since then and there are currently 23 clinical studies being conducted that are actively recruiting participants; many of these coming from Basking Ridge, New jersey."
What conditions is the Ofatumumab + Bendamustine drug regimen most commonly prescribed for?
"Ofatumumab + Bendamustine is usually prescribed for cases of multiple sclerosis. It can additionally help those who are resistant to fludarabine and alemtuzumab, cannot receive fludarabine-based therapy, or have active secondary progressive multiple sclerosis (spms)."
What potential risks does the combination of Ofatumumab and Bendamustine present to patients?
"Our team at Power has assigned Ofatumumab + Bendamustine a safety score of 2, as the drug is only in Phase 2 trials and thus lacks any efficacy data."
Is recruitment ongoing for this experiment?
"Unfortunately, this trial has already concluded its recruitment. Initially posted on September 1st 2011 and last edited October 3rd 2022, any interested parties have likely already joined the study. However, there are 1720 clinical trials for mantle cell lymphoma (MCL) and 23 Ofatumumab + Bendamustine studies that are still actively recruiting patients."
How many volunteers have signed up for this research experiment?
"This clinical trial is currently not enrolling, however it was initially posted on September 1st 2011 and most recently updated on October 3rd 2022. If you are seeking alternative studies, there exists 1720 experimental trials looking for candidates with mantle cell lymphoma (MCL) in addition to 23 research programs that require participants taking Ofatumumab + Bendamustine."
What is the expected outcome of this trial?
"The main goal of this two-year long trial is to determine the efficacy of a single drug, as determined by response rate. Secondary objectives include assessing Overall Survival using Kaplan-Meier estimation and logrank tests/Cox regression models; Progression Free Survival evaluated through the same process; and Response Duration calculated from confirmation of response (CR/PR) to progression with competing risks tools that consider death as an alternate outcome for progression in patients achieving CR or CR/PR."
How many locations are currently participating in this investigation?
"6 clinical sites have been identified for this trial. These include Memorial Sloan Kettering Cancer Center at Basking Ridge in Basking Ridge, Memorial Sloan Kettering West Harrison in Harrison and Memorial Sloan Kettering Cancer Center at Mercy Medical Center in Rockville Centre, among other medical centres."
Is this a fresh clinical trial?
"Research for the efficacy of Ofatumumab + Bendamustine began a decade ago, as GlaxoSmithKline sponsored its initial clinical trial in 2010. After this preliminary study, involving 32 patients, Phase 2 drug approval was granted and now 23 active trials are taking place across 290 cities spanning 45 countries."
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