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Rituximab + Lenalidomide + Ibrutinib for Follicular Lymphoma
Study Summary
This trial is testing the side effects and best dose of two drugs, lenalidomide and ibrutinib, when given with a third drug, rituximab, to treat patients with follicular lymphoma that has not been treated before.
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.Trial Design
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Who is running the clinical trial?
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- You have never had erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome.You cannot have had an allergic reaction to drugs that are similar to lenalidomide, ibrutinib, or other drugs used in this study.I have never taken the drugs being tested in this study.I haven't taken corticosteroids in the last two weeks, except for a low dose for a non-cancer condition.I have a tumor larger than 1 cm or my cancer can be measured by tests.My HIV viral load is under 10,000 copies/mL without HIV treatment.I have not taken strong drugs that affect liver enzymes recently.I have fluid around my lungs or heart.My non-Hodgkin lymphoma has affected my bone marrow.I have lymphangitis in my skin or lungs.I have fluid buildup in my abdomen.My creatinine levels are twice the upper limit or less, without needing extra help for a week.My heart rhythm is stable and controlled.I do not have heart failure.If you need a biopsy to diagnose your condition, a bone marrow biopsy alone is not enough. However, if it's done along with a biopsy of your lymph nodes, it's acceptable. Fine needle aspirates are not enough to make a diagnosis.I haven't had chemotherapy, radiotherapy, or major surgery in the last 4-6 weeks.I am not taking strong medications that affect liver enzymes.I have not had a brain bleed in the last 6 months.I am not pregnant or nursing and agree to follow strict birth control measures if of childbearing potential.I haven't taken warfarin in the last 28 days.My lymphoma has not spread to my brain or spinal cord.I haven't had a heart attack or blood clot in the last 6 months.I have not had cancer before, except for certain types allowed.My cancer was treated over 3 years ago, and my doctor believes it's unlikely to come back.My follicular lymphoma is classified with 0-5 FLIPI risk factors.My cervical cancer was treated and shows no signs of being present now.I have bone lesions.I do not have any serious heart conditions.I have a specific type of lymphoma that has not been treated and needs therapy.My cancer cells test positive for CD20.I have not had any treatment for non-Hodgkin lymphoma.I do not have active hepatitis B or C, or if HBV positive, I am monitored and treated.I have never had seizures that couldn't be controlled.I do not have an autoimmune disorder needing immunosuppressants.My heart condition does not severely limit my daily activities.I am 18 years old or older.My liver enzymes are within normal limits.I had skin cancer (not melanoma) or lentigo maligna melanoma, but it's now treated with no signs of the disease.My white blood cell count is healthy without needing medication or transfusions for the past week.My kidneys work well, with a creatinine clearance over 60 mL/min.I can take care of myself and am up and about more than half of the day.I have never had an AIDS-defining condition.My HIV is well-controlled with medication.I do not need blood transfusions for low platelet counts.
- Group 1: Treatment (lenalidomide, ibrutinib, and rituximab)
- 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
Are recruitment efforts ongoing for this experiment?
"According to the records posted on clinicaltrials.gov, this medical trial is not presently accepting applicants. The original posting was made June 21st 2013 and last updated August 11th 2022. However, there are 2440 other studies actively recruiting participants at the present moment in time."
What is the main purpose of this investigation?
"According to the trial sponsor, Celgene Corporation, the primary outcome over 28 days will be determining the maximally tolerated dose of lenalidomide and ibrutinib combined with rituximab through evaluating dose-limiting toxicities graded using NCI CTCAE version 4.0. Secondary outcomes include complete response rate estimated for each dosage level, overall survival estimated by Kaplan-Meier method at MTD., and overall response rate also assessed on a per dosage basis."
Which prior experiments have investigated the effects of pharmacological interventions?
"Currently, there are 721 live clinical trials researching Pharmacological Study with 149 at Phase 3. Of these many studies, the majority of research is occurring in Ascoli Piceno, Provincia yet over 28289 locations host trials for Pharmacological Study."
In what scenarios is a Pharmacological Study commonly employed?
"Pharmacological Study is typically prescribed to treat dlbcl and has been shown to be effective for managing a range of other conditions, including b-cell lymphomas, polyangium, and cases with two or more prior systemic chemotherapy regimens."
What is the estimated number of persons participating in this research endeavor?
"This medical trial is no longer open for enrollment. It was first listed on June 21st, 2013 and updated most recently on August 11th 2022. If you are in search of another study, clinicaltrials.gov lists 1719 trials actively recruiting participants with Ann Arbor Stage II Grade 1 Non-Contiguous Follicular lymphoma and 721 studies searching for volunteers interested in a Pharmacological Study."
How widely dispersed is the availability of this experiment?
"At present, 7 sites are taking on new patients for this trial. These include Chapel Hill, Buffalo and Boston as well as 4 other medical centres - it is essential to select a location in close proximity of your home to reduce travel needs if you choose to participate."
Has the Pharmacological Study attained authorization from the Federal Drug Administration?
"With limited data available evaluating both safety and efficacy, a score of 1 was assigned to this pharmacological study."
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