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Ibrutinib for Relapsed or Refractory Follicular Lymphoma
Study Summary
This trial looks at how well ibrutinib works in treating patients with follicular lymphoma that has come back or does not respond to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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 2022 Phase 3 trial • 201 Patients • NCT03053440Trial Design
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Who is running the clinical trial?
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- I haven't had chemotherapy or systemic therapy in the last 4 weeks.I have not had a stroke or brain bleed in the last 6 months.I need blood thinners like warfarin.I cannot swallow pills.I do not have any severe illnesses that my doctors are still trying to get under control.I have had a stem cell transplant from a donor.My lymphoma is confirmed as follicular, grades 1, 2, or 3a.I have a tumor or lymph node that is at least 1.5 cm big.I have not had radiotherapy in the last 4 weeks.I haven't taken Nitrosoureas or Mitomycin C in the last 6 weeks.I have not had major surgery in the last 10 days or minor surgery in the last 7 days.I have been treated with ibrutinib or a similar medication before.My cancer has spread to my brain or spinal cord.I am not taking strong medication that affects liver enzymes.I am not HIV-positive or not on antiretroviral therapy.My lymphoma has changed from follicular to diffuse large B-cell type.I do not have an active cancer other than non-melanoma skin cancer.I can provide a fresh biopsy of my tumor, or it's safe for me to have one done.My follicular lymphoma has returned or didn't respond after at least one chemotherapy treatment.I am able to care for myself and perform daily activities.My bilirubin levels are within normal range, unless I have Gilbert's syndrome or liver disease.My kidneys are functioning well enough (creatinine clearance >= 30 mL/min).I am currently breastfeeding.I have an active hepatitis B or C infection.I am of childbearing age and do not plan to use birth control.I haven't taken high doses of steroids in the last 14 days.
- Group 1: Treatment (ibrutinib)
- 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
In how many different medical clinics is this research study being conducted today?
"There are many places where patients can enroll in this study, for example University of Wisconsin Hospital and Clinics in Madison, Wisconsin as well as University Health Network-Princess Margaret Hospital in Toronto, Ontario. In addition, there are 12 other locations spread out across North America."
Has Ibrutinib received market authorization from the FDA?
"Ibrutinib is still in Phase 2 testing, so there is not yet enough evidence to support its efficacy. However, it did receive a score of 2 for safety."
Are participants still being recruited for this clinical trial?
"This study, as indicated by clinicaltrials.gov, is not recruiting patients at this time. Although the trial was last updated on 7/27/2022, it originally posted on 4/2/2013. There are currently 2858 other trials that are actively enrolling participants."
How many people have registered for this experiment?
"Presently, this clinical trial is not looking for new participants. It was initially posted on April 2nd, 2013 and updated last on July 27th, 2022. There are currently 2700 lymphoma studies and 158 Ibrutinib trials actively recruiting patients if you are interested in alternative research opportunities."
What is the body of evidence for Ibrutinib's efficacy?
"Ibrutinib was first investigated in a clinical setting at National Institutes of Health Clinical Center in 2011. As of now, there have been a total of 662 completed trials studying the effects of Ibrutinib. Out of these, 158 are still active. A large portion of these ongoing studies are based in Madison, Wisconsin."
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