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New treatment option for Recurrent Diffuse Large B-Cell Lymphoma
Official title Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT06536049
What this study is testing
What is Epcoritamab?
Epcoritamab is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for recurrent diffuse large b-cell lymphoma.
Also referred to as Anti-CD20/CD3 Bispecific Antibody GEN3013, DuoBody-CD3xCD20.
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
- This phase Ib/II trial evaluates the safety, optimal dose, and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or responded to previous treatment (refractory). Epcoritamab, a bispecific antibody, binds to two different types of receptors (proteins present on the cell surface) at the same time.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 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
- One of the following CD20+ B-cell non-Hodgkin lymphoma subtypes (note, documentation of CD20 positivity by flow cytometry and/or immunohistochemistry...
- Diffuse large B-cell lymphoma (DLBCL), including DLBCL, not otherwise specified (NOS); T-cell/histiocyte-rich large B-cell lymphoma; and Epstein-Barr...
- High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangements (double-hit or triple-hit lymphoma) or HGBL, NOS
- Primary mediastinal B-cell lymphoma (PMBCL)
- Follicular lymphoma, grade 3b (also known as follicular large B-cell lymphoma in the 5th edition of World Health Organization [WHO] classification of...
You likely can't join if
- Prior therapy with a bispecific antibody targeting CD3 and CD20
- Prior lymphoma therapy should be completed greater than two weeks before the start of protocol therapy, except for corticosteroids used for...
- Patients who require immediate cytoreductive therapy for their lymphoma per the treating physician's assessment are ineligible
- Patients with a history of allogeneic stem cell transplantation are excluded unless the transplant was \> 180 days before the first scheduled dose of...
- Ongoing systemic treatment with a strong CYP3A inhibitor or inducer. Treatment with any strong CYP3A inhibitor or inducer needs to be stopped for 5...
- Major surgery within 4 weeks before the start of treatment other than surgery performed for lymphoma diagnosis
See the full eligibility criteria
Who can join
- One of the following CD20+ B-cell non-Hodgkin lymphoma subtypes (note, documentation of CD20 positivity by flow cytometry and/or immunohistochemistry is based on any representative pathology report)
- Diffuse large B-cell lymphoma (DLBCL), including DLBCL, not otherwise specified (NOS); T-cell/histiocyte-rich large B-cell lymphoma; and Epstein-Barr virus-positive DLBCL, NOS
- High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangements (double-hit or triple-hit lymphoma) or HGBL, NOS
- Primary mediastinal B-cell lymphoma (PMBCL)
- Follicular lymphoma, grade 3b (also known as follicular large B-cell lymphoma in the 5th edition of World Health Organization [WHO] classification of lymphoid neoplasms)
- Patients with previously diagnosed indolent lymphoma (follicular lymphoma or marginal zone lymphoma but not lymphoplasmacytic lymphoma or small lymphocytic lymphoma/chronic lymphocytic leukemia) who have transformed to...
- Patients must have relapsed or refractory aggressive B-cell lymphoma and received prior treatment with an anthracycline in combination with an anti-CD20 monoclonal antibody:
- ≥ 2 prior systemic lymphoma treatments OR
- ≥ 1 prior systemic lymphoma treatment in patients with high-risk disease defined as primary refractory or relapsed within 12 months of completing anthracycline-based frontline treatment who are ineligible for chimeric...
- Prior treatment with a BTK inhibitor is allowed if stopped due to lymphoma progression or treatment completion but not intolerance
- Prior treatment with autologous stem cell transplant (ASCT) is allowed if ≥ 100 days prior to enrollment
- Prior treatment with CAR T cells is allowed if ≥ 30 days prior to enrollment
- Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of ibrutinib or epcoritamab in patients \< 18 years of age, children are excluded from this study
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Measurable disease (defined as \> 1.5 cm in diameter) or at least one PET fludeoxyglucose F-18 (FDG) avid area of disease
- Absolute neutrophil count (ANC) ≥ 1,000/mcL
- Platelet count ≥ 75,000/mcL. Platelet count ≥ 50,000/mcL is allowed in case of bone marrow involvement and/or splenomegaly
- Hemoglobin ≥ 8 g/dL
- Transfusion and/or growth factor support within 7 days (or 14 days in case of long-acting growth factors such as pegylated granulocyte colony-stimulating factor [G-CSF]) of enrollment to meet these requirements is not...
- Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN) (unless due to Gilbert's disease or hemolysis in which case bilirubin must be \< 3 x ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) \< 3 x institutional ULN
- Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) \< 3 x institutional ULN
- Creatinine clearance \> 45 mL/min calculated by Cockcroft-Gault. Patients on dialysis are not eligible
- The effects of ibrutinib and epcoritamab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth...
- Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [β-hCG]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study
- Patients must have the ability to understand and the willingness to sign a written informed consent document and Health Insurance Portability and Accountability Act (HIPAA) consent document. Voluntary written consent...
What rules you out
- Prior therapy with a bispecific antibody targeting CD3 and CD20
- Prior lymphoma therapy should be completed greater than two weeks before the start of protocol therapy, except for corticosteroids used for palliation of symptoms
- Patients who require immediate cytoreductive therapy for their lymphoma per the treating physician's assessment are ineligible
- Patients with a history of allogeneic stem cell transplantation are excluded unless the transplant was \> 180 days before the first scheduled dose of ibrutinib AND the patient does not have evidence of active acute or...
- Ongoing systemic treatment with a strong CYP3A inhibitor or inducer. Treatment with any strong CYP3A inhibitor or inducer needs to be stopped for 5 half-lives prior to starting treatment on trial
- Major surgery within 4 weeks before the start of treatment other than surgery performed for lymphoma diagnosis
- Known active central nervous system (CNS) involvement by lymphoma. Patients who are enrolled and subsequently identified to have pathologic confirmation of CNS involvement by lymphoma may be continued on the study at...
- Active uncontrolled infection or infection requiring intravenous (IV) antibiotic therapy for \> 2 consecutive days within 2 weeks prior to the first dose of study drug
- Evidence of current uncontrolled or symptomatic cardiovascular conditions, including, uncontrolled cardiac arrhythmias, history of or symptomatic congestive heart failure (New York Heart Association [NYHA] class III or...
- Known liver cirrhosis with moderate to severe hepatic impairment (Child-Pugh class B or C)
- Clinically significant pulmonary disease or history of bronchospasm requiring intubation, or clinically significant active interstitial lung disease or pneumonitis
- History of cerebrovascular accident or transient ischemic attack within the 6 months before day 1, cycle 1 of treatment
- Any prior history of intracranial hemorrhage
- Clinically significant known bleeding diatheses or platelet dysfunction disorders.
- Receiving treatment with coumadin/warfarin
- Known gastrointestinal disease or gastrointestinal procedure that will significantly interfere with the oral absorption or tolerance of ibrutinib including the inability to swallow pills/capsules
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
- Prior solid organ transplant
- History of other malignancies that could affect compliance with the protocol or interpretation of results in the opinion of the investigator
- Participation in other treatment clinical trials, including those with other investigational agents not included in this trial, within 21 days of the first scheduled dose of ibrutinib (cycle 1 day -7)
- Known history of HIV, active hepatitis C infection (HCV ribonucleic acid [RNA] polymerase chain reaction [PCR]-positive) and/or active hepatitis B infections (HBV DNA PCR-positive). If hepatitis B core (HBc) antibody is...
- Pregnant or breastfeeding women are excluded from this study. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with ibrutinib or epcoritamab...
- Patients with ongoing clinically significant grade ≥ 2 toxicity from prior therapy
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, 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 5 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 Minneapolis, Minnesota, 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.