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Ofatumumab Combination Therapy for Mantle Cell Lymphoma
Study Summary
This trial is studying how well ofatumumab in combination with other drugs works in treating patients with newly diagnosed mantle cell lymphoma.
- Mantle Cell Lymphoma
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 2021 Phase 3 trial • 319 Patients • NCT02004522Trial Design
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Who is running the clinical trial?
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- You have previously received radiation or chemotherapy for MCL (a type of cancer).You have had allergic reactions to similar medicines like ofatumumab or other drugs used in this study before.You have not received radiation therapy before for mantle cell lymphoma.You are not allergic to mouse-related products.Patients with different types of mantle cell cancer, regardless of its stage, can participate in the study.
- Group 1: Treatment (monoclonal antibody and combination chemotherapy)
- 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
What have been the findings regarding Ofatumumab's safety and efficacy?
"Ofatumumab has only been through a Phase 2 trial, so its safety rating is set at 2. This means there are some data pointing to it being safe, but none that prove efficacy yet."
Is this clinical trial currently accepting new participants?
"Regrettably, this clinical trial is not presently admitting new participants. It was initially posted on December 6th 2011 and last updated March 9th 2022. However, there are an abundance of other medical studies with open recruitment processes; 1720 trials require noncontiguous stage ii mantle cell lymphoma patients while a further 1,705 currently search for Ofatumumab qualified candidates."
Do I qualify to partake in this trial?
"For acceptance into this trial, eligible patients must have stage two mantle cell lymphoma and be between 18-70 years old. The team is aiming to recruit a total of 37 individuals for the study."
What precedent has been established with regards to research on Ofatumumab?
"Ofatumumab was first trialled in Spectrum Health Hospital - Butterworth Campus back in 1997, with 3648 completed studies to date. Presently there are 1705 active clinical trials across the United States of America, many being conducted in Buffalo, New york."
Is this experiment an unprecedented venture in its field?
"Currently, there are 1705 active studies of Ofatumumab taking place across 85 different nations and 3086 cities. The initial study for this drug began in 1997 under the sponsorship of Alfacell; it included 300 individuals and achieved Drug Approval Phase 3 status. Subsequently, a total of 3648 trials have been concluded since that time."
To what extent is enrollment being offered for this clinical trial?
"At this time, the trial is not actively recruiting. It was first posted on December 6th 2011 and last updated March 9th 2022; however, there are currently 1720 trials searching for participants with noncontiguous stage II mantle cell lymphoma and another 1705 trials that involve Ofatumumab presently looking for volunteers to enroll."
Does this research trial accept participants below the age of 40?
"According to the criteria for this medical study, the minimum age of enrolment is 18 and the upper limit is 70."
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