Epcoritamab for Waldenstrom's Macroglobulinemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called epcoritamab for individuals with Waldenstrom's macroglobulinemia (WM), a blood cancer that thickens the blood and impairs normal body function. The researchers aim to determine if epcoritamab can benefit those who have used Bruton tyrosine kinase inhibitors (BTKi) for over a year but still require better outcomes. Ideal candidates are adults with WM who have been on a BTKi, such as zanubrutinib or ibrutinib, for at least 12 months. Participants will receive epcoritamab injections over several months while continuing their current treatment. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
You will continue taking your current BTKi medication during the trial. However, if you are on certain other medications like CYP3A strong inducers or inhibitors, you may need to stop them before joining the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that epcoritamab is likely to be safe for humans?
Previous studies have shown that epcoritamab has a manageable safety profile for patients with Waldenstrom's macroglobulinemia (WM). Research indicates that common side effects include neutropenia, a low level of certain white blood cells, in about 15.3% of patients, and thrombocytopenia, a low platelet count, in about 11.5% of patients. These side effects are typical with cancer treatments and can usually be managed with medical care.
Overall, early findings suggest that patients generally tolerate epcoritamab well. While some may experience side effects like diarrhea, the drug's safety is considered acceptable for those with relapsed or refractory WM, meaning their disease has returned or not responded to previous treatments. This data indicates that epcoritamab could be a safe option for those eligible to join the clinical trial.12345Why do researchers think this study treatment might be promising?
Epcoritamab is unique because it offers a novel approach to treating Waldenstrom's Macroglobulinemia. Unlike current treatments, which often include drugs like zanubrutinib or ibrutinib targeting specific proteins on cancer cells, epcoritamab is a bispecific antibody. This means it simultaneously binds to two different targets, enhancing the immune system's ability to recognize and destroy cancer cells. Researchers are excited about epcoritamab because its dual-targeting mechanism could potentially lead to more effective and lasting responses in patients with this condition.
What evidence suggests that epcoritamab might be an effective treatment for Waldenstrom's macroglobulinemia?
In this trial, researchers will administer Epcoritamab as consolidative therapy for adults who have been receiving zanubrutinib or ibrutinib. Studies have shown that Epcoritamab can help treat certain blood cancers. Specifically, one study found that 61% of patients with relapsed B-cell lymphoma responded well to the treatment. Another study demonstrated that 95% of patients responded positively after about 15 months. Epcoritamab aids the immune system in identifying and destroying cancer cells. Although information is limited for Waldenstrom's macroglobulinemia, these results suggest it could be a promising treatment option.678910
Who Is on the Research Team?
Laura S Samples, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Are You a Good Fit for This Trial?
This trial is for adults (18+) with Waldenstrom macroglobulinemia who have been on a BTK inhibitor treatment for at least one year. Participants should be able to undergo blood tests, scans, and possibly bone marrow biopsies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive epcoritamab injections in 28-day cycles for 12 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Follow-up visits continue every 6 months for 3 years or more
What Are the Treatments Tested in This Trial?
Interventions
- Epcoritamab
Trial Overview
The study is testing epcoritamab, an injectable drug given under the skin in cycles alongside ongoing BTKi therapy. The goal is to see if adding epcoritamab helps control WM better after initial BTKi treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Epcoritamab will be administered as consolidative therapy in adults who have been receiving zanubrutinib or ibrutinib.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor
Citations
Epcoritamab Offers Durable Results in Relapsed B-Cell ...
Epcoritamab demonstrates efficacy in CAR T-naïve B-cell lymphoma patients, with 61% overall response and 45% complete response rates.
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43. Efficacy was demonstrated in a single-arm phase 2 clinical trial in which 106 patients (14 treatment-naive and 92 with relapsed or ...
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Epcoritamab reduced the risk for death by 79%. Presented ...
Epcoritamab reduced the risk for death by 79%. be an effective treatment among patients with R/R large B-cell #lymphoma, bringing your immune ...
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This phase I/II clinical trial evaluates the effectiveness and safety of epcoritamab in patients with relapsed or refractory Waldenstrom's macroglobulinemia ...
Waldenstrom Macroglobulinemia - Drugs, Targets, Patents
Broadly speaking, according to Alciati, the safety profiles of Zepbound and Wegovy are similar, with both drugs sharing common side effects ...
600 | FEATURES, EFFICACY ANALYSIS OF 118 CASES ...
This study systematically analyzed the adverse events ( and diarrhea (4.5%). neutropenia (15.3%) and thrombocytopenia (11.5%) were predominant, followed by ...
Waldenström's Macroglobulinemia Familial and Secondary ...
Lymphoma(LPL)/ Waldenström's Macroglobulinemia (WM) Age at diagnosis > 70, < 70 Male or Female The risks are not different in all categories
Efficacy and safety of epcoritamab in relapsed or refractory ...
Epcoritamab, a CD3xCD20 bispecific antibody, resulted in deep, durable responses with a manageable safety profile in patients with relapsed/refractory large ...
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