Lenalidomide + Epcoritamab for Follicular Lymphoma
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: City of Hope Medical Center
Must be taking: Aspirin, Blood thinners
Must not be taking: Live vaccines
Disqualifiers: CNS involvement, Active infection, Cardiovascular disease, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This phase II trial tests how well lenalidomide and epcoritamab works in treating patients with follicular lymphoma that has not been previously treated. Although follicular lymphoma is incurable, prognosis has improved for both early and advanced stage disease, largely attributed to therapeutic advances. Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing and by preventing the growth of new blood vessels that cancer cells need to grow. Epcoritamab is a bispecific monoclonal antibody that binds to two different antigens (the part of the target that the antibody attaches to), at the same time. This dual action allows bispecific antibodies to improve target specificity by binding two antigens on the same cell to recruit and activate immune cells to kill cancer cells. Lenalidomide and epcoritamab, when given together, may be more effective in treating patients with follicular lymphoma than if they were given alone.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants must not be on certain treatments like anticoagulants unless specific conditions are met. It's best to discuss your current medications with the trial team to get a clear answer.
What data supports the effectiveness of the drug combination Lenalidomide and Epcoritamab for treating follicular lymphoma?
Research shows that Lenalidomide, when combined with another drug called rituximab, significantly helps patients with follicular lymphoma by slowing down the progression of the disease. This suggests that Lenalidomide can be effective in treating follicular lymphoma, and combining it with Epcoritamab might offer similar benefits.
12345Is the combination of Lenalidomide and Epcoritamab safe for treating follicular lymphoma?
Lenalidomide, when used with rituximab, has shown an acceptable safety profile in treating follicular lymphoma, though it can cause some blood-related side effects like neutropenia (low white blood cell count), which are generally manageable. There is no specific safety data available for the combination of Lenalidomide and Epcoritamab in the provided research.
12367What makes the drug combination of Lenalidomide and Epcoritamab unique for treating follicular lymphoma?
The combination of Lenalidomide and Epcoritamab is unique because Lenalidomide is an oral immunomodulatory drug that enhances the immune system's ability to fight cancer, while Epcoritamab is a bispecific antibody that targets specific proteins on cancer cells, potentially offering a novel approach compared to traditional chemotherapy.
13589Eligibility Criteria
Adults over 18 with untreated Follicular Lymphoma (FL) grade 1-3a who need treatment. They must have measurable lymphadenopathy or extranodal involvement, acceptable organ function tests, and for women of childbearing potential, a negative pregnancy test and agreement to use effective birth control. Excluded are those with certain heart conditions, active infections like hepatitis B/C or HIV, other recent malignancies, pregnant/breastfeeding women, and anyone unlikely to follow the study procedures.Inclusion Criteria
My follicular lymphoma is confirmed and needs treatment according to GELF criteria.
My platelet count is at least 50,000 without bone marrow issues.
Your total bilirubin is no more than twice the maximum allowable concentration, except if you have Gilbert's disease.
+21 more
Exclusion Criteria
I have HIV but it's under control with medication.
I am not pregnant, breastfeeding, nor plan to become pregnant soon.
My prostate cancer is being monitored or treated with hormones.
+16 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive lenalidomide orally once daily on days 1-21 of each cycle and epcoritamab subcutaneously on days 1, 8, 15, and 21 of cycles 1-3 and on day 1 of each subsequent cycle. Treatment repeats every 28 days for up to 12 cycles.
12 months
4 visits per cycle (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up includes safety checks on days 7, 30, and 60, active response monitoring every 6 months for up to 2 years, and survival monitoring every 6 months.
2 years
Participant Groups
The trial is testing the effectiveness of combining Lenalidomide (which affects the immune system and blood vessel growth in cancer cells) with Epcoritamab (a dual-action antibody that targets cancer cells more specifically). This phase II trial includes additional diagnostic procedures like bone marrow biopsy and imaging tests such as CT scans, MRIs, PET scans to monitor disease progression.
1Treatment groups
Experimental Treatment
Group I: Treatment (lenalidomide and epcoritamab)Experimental Treatment8 Interventions
Patients receive lenalidomide PO QD on days 1-21 of each cycle and epcoritamab SC on days 1, 8, 15, and 21 of cycles 1-3 and on day 1 of each subsequent cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients may be re-treated with study treatment at any point during the follow-up period as long as they did not progress during treatment or stop due to unacceptable toxicity. Patients also undergo CT, PET/CT, or MRI as well as bone marrow biopsy throughout the trial. Patients undergo blood sample collection on trial and during follow-up.
Epcoritamab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Epkinly for:
- Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
- Diffuse large B-cell lymphoma after two or more lines of systemic therapy
🇪🇺 Approved in European Union as Tepkinly for:
- Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
- Relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
City of Hope Medical CenterDuarte, CA
City of Hope at Irvine LennarIrvine, CA
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Who Is Running the Clinical Trial?
City of Hope Medical CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Lenalidomide: A Review in Previously Treated Follicular Lymphoma. [2021]Lenalidomide (Revlimid®) is a targeted immunomodulatory drug with multiple mechanisms of action. In the USA and the EU, oral lenalidomide is indicated in combination with rituximab or a rituximab product for the treatment of patients with previously treated follicular lymphoma. In the pivotal, phase III AUGMENT trial, lenalidomide + rituximab significantly prolonged progression-free survival (PFS; primary endpoint) relative to placebo + rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma, with the PFS benefit appearing to be specific to patients with follicular lymphoma and extending to elderly patients with this subtype. Lenalidomide + rituximab also demonstrated activity in an interim analysis of the phase III MAGNIFY trial in patients with relapsed or refractory indolent non-Hodgkin lymphoma, including those with rituximab-refractory disease. Lenalidomide had an acceptable tolerability profile. Although grade 3 or 4 neutropenia occurred more frequently with lenalidomide + rituximab than with placebo + rituximab, this was generally well managed with dosage adjustments and growth factor support. In conclusion, lenalidomide in combination with rituximab represents an important new treatment option for previously treated follicular lymphoma, including patients whose disease has become refractory to rituximab.
A phase II trial of lenalidomide plus rituximab in previously untreated follicular non-Hodgkin's lymphoma (NHL): CALGB 50803 (Alliance). [2023]This multicenter, phase II trial tested the tolerability and efficacy of lenalidomide plus rituximab in patients with previously untreated follicular lymphoma (FL).
The evolving role of lenalidomide in non-Hodgkin lymphoma. [2019]Recent advances in the treatment of patients with non-Hodgkin lymphoma have driven a paradigm shift from standard chemotherapy to an ever-expanding choice of targeted agents and combinations. As an orally bioavailable immunomodulator with antineoplastic, immunologic, and antiproliferative activity in B-cell lymphoma, lenalidomide has emerged as one such option. Lenalidomide demonstrates clinically significant activity with a favorable safety profile as a single agent, as well as in combination therapy. Herein, we review accumulated clinical data on lenalidomide, with particular reference to patients with first-line and relapsed/refractory mantle cell lymphoma, indolent lymphoma, and diffuse large B-cell lymphoma.
A comprehensive review of lenalidomide in B-cell non-Hodgkin lymphoma. [2022]Lenalidomide, an immunomodulatory drug that the US Food and Drug Administration (FDA) approved for the treatment of multiple myeloma, 5q- myelodysplasia and mantle-cell lymphoma (MCL), has encouraging efficacy in other B-cell malignancies. Its unique mechanism of action is in part due to altering the tumor microenvironment and potentiating the activity of T and natural-killer (NK) cells. Impressive clinical activity and excellent tolerability allows broad applicability. Lenalidomide has been used in a wide range of B-cell malignancies for years, but in 2013, the FDA marked its approval as a single agent only in relapsed/refractory mantle-cell lymphoma. Perhaps most impressive is the efficacy of lenalidomide when combined with monoclonal antibodies. Impressive efficacy and toxicity profiles with the combination of lenalidomide and rituximab in B-cell lymphomas in both the upfront and relapsed/refractory setting may allow a shift in our current treatment paradigm in both indolent and aggressive non-Hodgkin lymphoma (NHL). This review will summarize the current data in the relapsed/refractory and front-line setting of NHL with single-agent lenalidomide as well as its use in combination with other agents.
Randomized Trial of Lenalidomide Alone Versus Lenalidomide Plus Rituximab in Patients With Recurrent Follicular Lymphoma: CALGB 50401 (Alliance). [2022]Lenalidomide and rituximab (LR) are active agents in follicular lymphoma (FL). Combination regimens have not been previously assessed in randomized studies.
Efficacy and safety of lenalidomide in diffuse large B-cell lymphoma: a meta-analysis of randomized controlled trials. [2023]As an immunomodulatory agent with antitumor activity, lenalidomide has been evaluated for its value in diffuse large B-cell lymphoma (DLBCL). We performed a meta-analysis to gain a better understanding of the efficacy and safety of lenalidomide in DLBCL. PubMed, Cochrane Library, and Embase were searched up to March 2022 for potential studies. The pooled hazard ratio (HR) and relative risk (RR) with 95% confidence interval (CI) were estimated by the fixed/random effects model. Overall, 6 randomized controlled trials including 1938 patients were included. The complete response rate (CRR) of the group containing lenalidomide was 47.7% (95%CI 28.5-67.2%), which was higher than the 37.8% (95%CI 16.7-61.5%) of the control group without lenalidomide (RR = 1.11, 95%CI 1.03-1.20, P = 0.008). The overall estimation of survival showed a benefit for progression-free survival (PFS) (HR = 0.77, 95%CI 0.66-0.90, P = 0.001) but not overall survival (OS) or event-free survival (EFS). The lenalidomide group had a significant incidence of grade ≥ 3 hematological adverse events (AEs) involving neutropenia (RR = 1.56, 95%CI 1.15-2.11, P = 0.004) and febrile neutropenia (RR = 1.81, 95%CI 1.31-2.49, P
Lenalidomide in follicular lymphoma. [2021]Lenalidomide is an immunomodulatory drug approved in the United States for use with rituximab in patients with relapsed/refractory follicular lymphoma. We reviewed data from trials addressing the safety and efficacy of lenalidomide alone and in combination with rituximab as a first-line therapy and as a treatment of patients with relapsed/refractory follicular lymphoma. Lenalidomide-rituximab has been demonstrated to be an effective chemotherapy-free therapy that improves upon single-agent rituximab and may become an alternative to chemoimmunotherapy.
An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. [2022]Lenalidomide is an immunomodulatory agent with antitumor activity in B-cell malignancies. This phase II trial aimed to demonstrate the safety and efficacy of lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), follicular grade 3 lymphoma (FL-III), or transformed lymphoma (TL).
Lenalidomide in diffuse large B-cell lymphoma. [2021]Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin's lymphoma (NHL) in adults. Even if the natural history of DLBCL has been improved with the advent of immunochemotherapy, the survival results obtained with current treatment options clearly indicate that new agents or novel approaches are needed. Lenalidomide (Revlimid, Celgene Corporation, Summit, NJ, USA), an analogue of thalidomide, is an immunomodulatory drug with pleiotropic mechanisms of action potentially adding to immunochemotherapy. We present here the biological rational for the use of lenalidomide in DLBCL in light of recent advances in the pathophysiology of the disease and the therapeutic results of the most recent trials published in literature or reported in meetings in relapsed/refractory situations as well as in first-line treatment.