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New treatment option for Follicular Lymphoma
Official title Epcoritamab and Rituximab for First-line Follicular Lymphoma
ClinicalTrials.gov ID: NCT05783609
What this study is testing
What is Epcoritamab?
Epcoritamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for follicular lymphoma.
Also referred to as DuoBody-CD3xCD20, GEN3013.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine how effective and safe the combination of rituximab and epcoritamab is in treating patients with Follicular Lymphoma (FL) and who have not received other treatments for their lymphoma. The names of the study drugs involved in this study are: Rituximab (a type of monoclonal antibody therapy) Epcoritamab (a T-cell bispecific antibody)
- Phase 2: a mid-size study of how well it works
- Time commitment: about 10 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed diagnosis of CD20+ FL (grade 1-3A) with review of the diagnostic pathology specimen at one of the participating...
- No prior systemic therapy for FL. Prior treatment with radiation therapy or short course steroids is allowed.
- Meets at least one criterion to begin treatment based on the modified GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria:
- Symptomatic adenopathy
- Organ function impairment due to disease involvement, including cytopenias due to marrow involvement (WBC \<1.5x109/L; absolute neutrophil count...
You likely can't join if
- Patients who require systemic immunosuppressive therapy for an ongoing medical condition will be excluded. For corticosteroids, patients receiving a...
- Patients with bulky cervical adenopathy that is compressing the upper airway or could result in significant airway compression during a tumor flare...
- Patients with stage I follicular lymphoma
- Patients who are candidates for radiation therapy with curative intent (in the opinion of the treating investigator)
- Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from...
- Active HBV (DNA PCR-positive) or hepatitis C (RNA PCR-positive infection). people with evidence of prior HBV but who are PCR-negative are permitted...
See the full eligibility criteria
Who can join
- Histologically confirmed diagnosis of CD20+ FL (grade 1-3A) with review of the diagnostic pathology specimen at one of the participating institutions. Patients with current or prior histologic transformation are...
- No prior systemic therapy for FL. Prior treatment with radiation therapy or short course steroids is allowed.
- Meets at least one criterion to begin treatment based on the modified GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria:
- Symptomatic adenopathy
- Organ function impairment due to disease involvement, including cytopenias due to marrow involvement (WBC \<1.5x109/L; absolute neutrophil count [ANC] \<1.0x109/L, Hgb \<10g/dL; or platelets \<100x109/L)
- Constitutional symptoms (defined as persistent fevers \>100.4 F, shaking chills, drenching night sweats, or loss of \>10% of body weight within a 6 month period)
- Any nodal or extranodal tumor mass \>7 cm in maximum diameter
- \>3 nodal sites of involvement \>3 cm
- Local compressive symptoms or imminent risk thereof
- Splenomegaly (craniocaudal diameter \> 16cm on CT imaging)
- Clinically significant pleural or peritoneal effusion
- Leukemic phase (\>5x109/L circulating malignant cells)
- Rapid generalized disease progression
- Renal infiltration
- Bone lesions
- Patients cannot be in need of urgent cytoreductive chemotherapy (in the opinion of the treating investigator).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. (Appendix A)
- Age ≥18 years.
- Adequate hematologic and organ function:
- Absolute neutrophil count \> 1.0x109/L unless due to marrow involvement by lymphoma in which case ANC must be \>0.5x109/L
- Platelets \> 75 x109/L, unless due to marrow involvement by lymphoma, in which case platelets must be \>50 x109/L
- Estimated CrCl (Cockcroft Gault) ≥ 45ml/min
- Total bilirubin \< 1.5 X ULN, unless Gilbert syndrome, in which case direct bilirubin must be \< 1.5 x ULN
- AST/ALT \< 2.5 X ULN, unless documented liver involvement by lymphoma, in which case AST/ALT must be \<5 x ULN
- Ability to understand and the willingness to sign a written informed consent document.
- Willingness to provide a pre-treatment tumor sample by core needle or excisional surgical biopsy. A fresh biopsy is strongly encouraged, but an archival sample is acceptable if the following provisions are met: 1)...
- Willingness to remain abstinent or to use two effective contraceptive methods that result in a failure rate of \<1% per year from screening until: (a) at least 3 months after pre-treatment with rituximab or 12 months...
- Tubal ligation, male sterilization, hormonal implants, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
- Alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of \<1% per year. Barrier methods must always be supplemented with the use of a...
What rules you out
- Patients who require systemic immunosuppressive therapy for an ongoing medical condition will be excluded. For corticosteroids, patients receiving a prednisone dose of \>10 mg daily (or equivalent) will not be eligible...
- Patients with bulky cervical adenopathy that is compressing the upper airway or could result in significant airway compression during a tumor flare event.
- Patients with stage I follicular lymphoma
- Patients who are candidates for radiation therapy with curative intent (in the opinion of the treating investigator)
- Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general...
- Active HBV (DNA PCR-positive) or hepatitis C (RNA PCR-positive infection). people with evidence of prior HBV but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy. people...
- Known history of seropositivity for human immunodeficiency virus (HIV). Note: HIV testing is required at screening only if required per local health authorities or institutional standards.
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at trial enrolment or significant infections within 2 weeks prior to the first dose of...
- Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least 2 years.
- Patients should not have received immunization with attenuated live vaccine within one week of study entry or during study period.
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study or limit adherence to study requirements.
- Patients with any one of the following currently on or in the previous 6 months will be excluded: myocardial infarction, congenital long QT syndrome, torsade de pointes, unstable angina, coronary/peripheral artery...
- Patients with New York Heart Association Class III or IV heart failure or known ejection fraction of \<45%.
- Inability to comply with protocol mandated hospitalizations and restrictions.
- Patients who are pregnant, breast-feeding, or intending to become pregnant during the study.
- Prior solid organ or allogeneic stem cell transplantation.
- History of known or suspected hemophagocytic lymphohistiocytosis (HLH).
- History of autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease...
- Patients with a remote history of, or well controlled, autoimmune disease who meet above criteria may be eligible to enroll after consultation with the Sponsor-Investigator.
- History of severe allergic or anaphylactic reactions to anti-CD20 mAb therapy or known allergy or intolerance to any component or excipient of epcoritamab.
- Vaccination with live vaccines within 28 days prior to the first dose of epcoritamab.
- Active CNS lymphoma
- Neuropathy \> grade 2. (CTCAE)
- Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab.
- Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to the first dose of epcoritamab.
- Chemotherapy and other non-investigational anti-neoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of epcoritamab.
- No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If a subject has signs/symptoms suggestive of SARS-CoV-2 infection or had recent known exposure to someone with SARS-CoV-2...
- No signs/symptoms suggestive of active SARS-CoV-2 infection
- Negative molecular (e.g., PCR) result or 2 negative antigen test results at least 24 hours apart
- Screening 12-lead ECG showing a baseline QTcF \>470 msec.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- New York, New York, United States
- Rochester, New York, United States
- Columbus, Ohio, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; New York, New York, United States; Rochester, New York, United States; Columbus, Ohio, United States; Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.