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New treatment option for Follicular Lymphoma
Official title Epco, Zanu, Ritux for R/R FL or MZL
ClinicalTrials.gov ID: NCT06563596
What this study is testing
What is Zanubrutinib?
Zanubrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for follicular lymphoma.
Also referred to as BDB-3111, Brukinsa.
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 epcoritamab, zanubrutinib, and rituximab is in treating participants with relapse or refractory Follicular Lymphoma (FL) or marginal zone lymphoma (MZL). The names of the study drugs involved in this research study are: Epcoritamab (a type of antibody) Zanubrutinib (a type of Bruton tyrosine kinase inhibitor) Rituximab (a type of monoclonal 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) or CD20+ MZL (any subtype) (at time of trial entry) with review of the diagnostic...
- Receipt of at least one prior line of therapy for FL or MZL (with prior treatment including a CD20 monoclonal antibody).
- Measurable disease, defined as ≥1 measurable nodal lesion (long axis \>1.5 cm or short axis \>1.0 cm), or ≥1 measurable extra-nodal lesion (long axis...
- Meets at least one criterion to begin treatment based on the modified GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria:
- Symptomatic adenopathy
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, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from...
- Presence of HCV antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable (NOTE: the limit of detection for HCV RNA...
- Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with positive hepatitis B serologies with undetectable...
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) requiring...
See the full eligibility criteria
Who can join
- Histologically confirmed diagnosis of CD20+ FL (grade 1-3A) or CD20+ MZL (any subtype) (at time of trial entry) with review of the diagnostic pathology specimen at one of the participating institutions. Patients with...
- Receipt of at least one prior line of therapy for FL or MZL (with prior treatment including a CD20 monoclonal antibody).
- Measurable disease, defined as ≥1 measurable nodal lesion (long axis \>1.5 cm or short axis \>1.0 cm), or ≥1 measurable extra-nodal lesion (long axis \>1.0 cm), or spleen \>13 cm on PET, CT, or magnetic resonance...
- 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 6 months)
- 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
- 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 (based on Cockcroft Gault or MDRD) ≥ 45ml/min or ≥ 45ml/min/1.73m2
- 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 it is collected within 90 days and without...
- Willingness to remain abstinent (1) or to use two effective contraceptive methods that result in a failure rate of \<1% per year from screening until: (a) at least 12 months after pre-treatment with rituximab, 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...
- True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. In contrast, periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and...
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, 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...
- Presence of HCV antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable (NOTE: the limit of detection for HCV RNA must have a sensitivity of \< 15 IU/mL). people who received treatment...
- Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with positive hepatitis B serologies with undetectable HBV DNA (NOTE: the limit of detection for HBV DNA must have a...
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) requiring antimicrobial therapy at trial enrolment or significant infections within 2 weeks...
- Subject has a 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 has had recent known exposure to someone with...
- 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
- Prior history of another malignancy (except for non-melanoma skin cancer, in situ cervical or breast cancer, or Gleason 6 prostate cancer managed with observation) unless disease free for at least 2 years OR unless the...
- Patients should not have received immunization with attenuated live vaccine within one week of study entry or during study period. Vaccination with live vaccines within 28 days of the first dose of study treatment is...
- 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 1) New York Heart Association Class III or IV heart failure or known ejection fraction of \<45%, 2) MI within 6 months prior to screening, 3) unstable angina within 3 months before screening, or 4) history...
- Inability to comply with protocol mandated 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 clinically significant autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis...
- 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.
- Inability to tolerate anti-CD20 mAb therapy or known allergy or intolerance to any component or excipient of epcoritamab.
- Known central nervous system involvement
- Neuropathy \> grade 1(based on CTCAE grading)
- Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab.
- Treatment with an investigational drug within 4 weeks prior to the first dose of study treatment.
- Chemotherapy and other non-investigational anti-neoplastic agents (except CD20 mAbs) within 4 weeks prior to the first dose of study treatment.
- Participants who require warfarin or other vitamin K antagonists for anticoagulation. Other anticoagulants including direct oral anticoagulants (i.e. apixaban, rivaroxaban) and low-molecular weight heparin are allowed.
- Participants who are known at the time of study entry to require concomitant treatment with any medications or substances that are strong CYP3A inducers. Because the lists of these agents are constantly changing, it is...
- Unable to swallow capsules or disease significantly affecting gastrointestinal function, such as malabsorption syndrome.
- History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusions or other medical interventions. Requires ongoing treatment...
- Prior exposure to a BTK inhibitor
- A limited number of patients with BsAb-refractory disease will be permitted to enroll in each cohort (see section 2.5.3). After this limit is reached, patients with BsAb-refractory disease will be excluded...
- Screening 12-lead ECG showing a baseline QTcF (Fridericia's correction) \> 480 msec.
- History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.
- Major surgery ≤ 4 weeks before the first dose of study treatment or planned during study.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- New York, New York, United States
- Columbus, Ohio, 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; Columbus, Ohio, 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.