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Lenalidomide + Nivolumab for Lymphoma
Study Summary
This trial is to find out the best dose of lenalidomide when added to nivolumab and the usual drugs (rituximab and methotrexate) in patients with primary central nervous system (CNS) lymphoma. Lenalidomide may stop or slow primary CNS lymphoma by blocking the growth of new blood vessels necessary for tumor growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread.
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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- I have not had chemotherapy or radiation for lymphoma.You haven't had a serious allergic reaction to any type of antibody medication before.I have stopped taking certain medications like pain relievers and antibiotics 48 hours before methotrexate treatment.I can perform daily activities with some assistance.I do not have untreated HIV or a low CD4+T-cell count.I do not have an autoimmune disorder that affects my organs or requires steroids.I am not on long-term steroids or immunosuppressants, except for low-dose or topical ones.I do not have an active hepatitis B infection.You have not had any allergic reactions to similar drugs or substances used in the study.I have not had a stem cell transplant from a donor.I have no other cancers except possibly treated skin cancer or uterine CIS.I cannot tolerate common blood thinners.I do not have HIV and my brain lymphoma is related to the Epstein Barr virus.My diagnosis of CNS lymphoma was confirmed through a biopsy or fluid test.I have not had an organ transplant.I am using steroids for my condition but can reduce them if needed.I am 18 years old or older.I have never had non-Hodgkin lymphoma.I am not pregnant or nursing and have a negative pregnancy test.My lymphoma is only in my central nervous system.You cannot be currently receiving any other experimental drugs or treatments.I am not currently receiving treatment for another cancer.I have certain autoimmune conditions like vitiligo or type I diabetes but they are under control.I have been checked for serious gut conditions before joining the study.
- Group 1: Treatment (rituximab, methotrexate, lenalidomide, nivolumab)
- 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 is the current regulatory status of Lenalidomide?
"Lenalidomide scores 1 out of 3 on our safety scale as it is a Phase 1 trial, meaning there are few studies to support efficacy and limited evidence related to safety."
Are there currently opportunities to participate in this trial?
"Affirmative. According to information on clinicaltrials.gov, this trial is still admitting individuals for participation and was initially posted in January 2021 with the most recent update occurring in November 2022. A total of 32 patients are required from a pool of 32 medical centres involved in the study."
Has lenalidomide been subject to previous research studies?
"In 1993, lenalidomide's clinical trials first began at the National Institutes of Health Clinical Center located in Rockville Pike. Since then, a total of 1908 different studies have been completed with 1487 still running today; many are hosted by Weston, Wisconsin."
In what circumstance is Lenalidomide most commonly prescribed?
"Primarily, lenalidomide is administered to those with metastatic urothelial carcinoma of the ureter. Yet this therapeutic agent may also aid individuals suffering from malignant melanoma of skin, chronic lymphocytic leukemia, and metastatic hepatocellular carcinoma."
How widely distributed is this clinical test being performed?
"This experiment is being conducted at Marshfield Medical Center - Weston in Weston, Wisconsin, Huntsman Cancer Institute/University of Utah in Salt Lake City, Utah and at Marshfield Medical Center-Rice Lake in Rice Lake, Texas. Moreover, 32 additional sites are involved as well."
To what extent are participants enrolled in this clinical experiment?
"To fulfill the requirements of this trial, 32 eligible patients need to be enrolled. Those seeking participation can visit Marshfield Medical Center - Weston in Weston, Wisconsin and Huntsman Cancer Institute/University of Utah in Salt Lake City, Utah for further details."
What is the intent of this medical experiment?
"The primary purpose of this 6 month clinical trial is to determine the Maximum Tolerated Dose (MTD). Secondary objectives include estimating Overall Response Rate, Incidence of Adverse Events and Progression-Free Survival. For each outcome, descriptive statistics will be employed such as exact binomial 95% confidence intervals for response rate and Kaplan-Meier estimates for PFS."
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