47 Participants Needed

Lenalidomide + Nivolumab for Lymphoma

Recruiting at 49 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of drugs to treat a rare brain cancer. The treatment aims to starve the tumor, boost the immune system, and stop cancer cells from growing. It targets patients with primary CNS lymphoma who may not respond well to standard treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it does mention that certain drugs like sulfonamide drugs, trimethoprim, and others should be stopped at least 48 hours before methotrexate administration. It's best to discuss your specific medications with the trial team.

What is the safety profile of rituximab in humans?

Rituximab is generally well tolerated, but it can cause some side effects like high blood pressure, swelling, and rare heart issues. It may also increase the risk of infections, including serious ones like hepatitis B reactivation and a rare brain infection called PML.12345

What makes the drug Lenalidomide + Nivolumab unique for treating lymphoma?

The combination of Lenalidomide and Nivolumab for lymphoma is unique because Lenalidomide is an oral immunomodulatory drug that enhances the immune system's ability to fight cancer cells, and when combined with Nivolumab, an immune checkpoint inhibitor, it may offer a novel approach to overcoming resistance to traditional treatments like Rituximab, especially in patients with certain types of B-cell lymphomas.678910

What evidence supports the effectiveness of the drugs Lenalidomide and Nivolumab for treating lymphoma?

Rituximab, a drug often used in combination with other treatments for lymphoma, has shown significant improvements in outcomes for patients with non-Hodgkin's lymphoma, including better survival rates and response rates. This suggests that combining targeted therapies like Rituximab with other drugs could be effective in treating lymphoma.1112131415

Who Is on the Research Team?

AJ

Alvaro J Alencar

Principal Investigator

Alliance for Clinical Trials in Oncology

Are You a Good Fit for This Trial?

Adults diagnosed with primary CNS diffuse large B-cell lymphoma who haven't had prior chemotherapy, radiation, or organ/stem cell transplants. They must have a certain level of physical function and adequate blood counts. Pregnant or nursing women are excluded, as well as those with autoimmune diseases that could affect the trial's safety.

Inclusion Criteria

I have not had chemotherapy or radiation for lymphoma.
Absolute neutrophil count (ANC) >= 1,500/mm^3
I can perform daily activities with some assistance.
See 15 more

Exclusion Criteria

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 do not have untreated HIV or a low CD4+T-cell count.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Induction

Patients receive rituximab, methotrexate, lenalidomide, and nivolumab. Treatment repeats every 14 days for up to 6 cycles.

12 weeks
6 visits (in-person)

Maintenance

Patients receive lenalidomide and nivolumab. Treatment repeats every 28 days for up to 12 cycles.

48 weeks
12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

Up to 4 years
Every 3 months for 2 years, then every 6 months for up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Lenalidomide
  • Methotrexate
  • Nivolumab
  • Rituximab
Trial Overview The trial is testing if adding Lenalidomide to Nivolumab along with usual drugs Rituximab and Methotrexate can improve treatment for primary CNS lymphoma. It aims to find the best dose and see if these drugs can extend control over the cancer after initial success.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (rituximab, methotrexate, lenalidomide, nivolumab)Experimental Treatment11 Interventions

Methotrexate is already approved in United States, Canada, European Union for the following indications:

🇺🇸
Approved in United States as Trexall for:
🇨🇦
Approved in Canada as Mexate for:
🇪🇺
Approved in European Union as Methotrexate for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Rituximab has significantly improved outcomes for patients with Non-Hodgkin's lymphoma (NHL), particularly in aggressive forms like diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL).
The treatment is generally well-tolerated by patients and has been shown to be cost-effective, making it a valuable option in both initial and relapsed cases of B cell NHL.
Rituximab in the treatment of non-Hodgkin's lymphoma--a critical evaluation of randomized controlled trials.Griffin, MM., Morley, N.[2020]
Rituximab, when added to standard chemotherapy, significantly improved survival rates in patients with non-Hodgkin's lymphoma.
In patients with chronic B-cell lymphocytic leukemia, the addition of rituximab to fludarabine-based regimens enhanced both response rates and overall survival.
Review of the safety and feasibility of rapid infusion of rituximab.Atmar, J.[2022]
Rituximab, a chimeric anti-CD20 monoclonal antibody, has shown to induce responses in nearly 50% of patients with relapsed follicular/low-grade non-Hodgkin's lymphoma, with complete remissions occurring in 6% of cases, highlighting its efficacy in treating this type of cancer.
The drug is generally well tolerated, with common side effects being mild to moderate fevers and chills, and it is also effective against various other B-cell malignancies, suggesting its potential for broader applications in both cancer treatment and autoimmune disorders.
Rituximab: clinical development and future directions.Cheson, BD.[2019]

Citations

Rituximab in the treatment of non-Hodgkin's lymphoma--a critical evaluation of randomized controlled trials. [2020]
Review of the safety and feasibility of rapid infusion of rituximab. [2022]
Rituximab: clinical development and future directions. [2019]
Monoclonal antibody therapy in lymphoid malignancies. [2019]
Combination immunotherapy of relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma with rituximab and interferon-alpha-2a. [2022]
Evaluation of the safety of rituximab in combination with a tumor necrosis factor inhibitor and methotrexate in patients with active rheumatoid arthritis: results from a randomized controlled trial. [2015]
Phase II study of rituximab in combination with chop chemotherapy in patients with previously untreated, aggressive non-Hodgkin's lymphoma. [2022]
Long-term safety of rituximab in rheumatoid arthritis: 9.5-year follow-up of the global clinical trial programme with a focus on adverse events of interest in RA patients. [2021]
Anterior ST-elevation myocardial infarction induced by rituximab infusion: A case report and review of the literature. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Rituximab-associated infections. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
The evolving role of lenalidomide in non-Hodgkin lymphoma. [2019]
Immunomodulation therapy with lenalidomide in follicular, transformed and diffuse large B cell lymphoma: current data on safety and efficacy. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Lenalidomide in follicular lymphoma. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
Combination of Lenalidomide and Rituximab Overcomes Rituximab Resistance in Patients with Indolent B-cell and Mantle Cell Lymphomas. [2022]
Lenalidomide: A Review in Previously Treated Follicular Lymphoma. [2021]
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