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Compares treatment options for Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Official title Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy
ClinicalTrials.gov ID: NCT06238648
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 diffuse large b-cell lymphoma, not otherwise specified.
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 II trial compares epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy. Epcoritamab is a bispecific antibody.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
- Which group you join is decided by chance.
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
- Men and women \>= 18 years of age
- Documented histological confirmation of diffuse large b-cell lymphoma not otherwise specified [DLBCL NOS], primary mediastinal large b-cell lymphoma...
- Patients treated with the commercially available CD19-directed CAR-T products axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or...
- Documented measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2. (Form is available on the Academic and Community Cancer Research United...
You likely can't join if
- Patients post CAR-T who have bulky disease defined as a disease focus \>= 7.5cm in diameter at day 30 +/- 7 days PET-CT assessment
- Patients post CAR-T who have progressive disease, stable disease or complete response at day 30 +/- 7 days PET-CT assessment based on Lugano criteria
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effect on the developing fetus...
- Pregnant persons
- Nursing persons
- Persons of childbearing potential who are unwilling to employ adequate contraception (men and women)
See the full eligibility criteria
Who can join
- Men and women \>= 18 years of age
- Documented histological confirmation of diffuse large b-cell lymphoma not otherwise specified [DLBCL NOS], primary mediastinal large b-cell lymphoma (LBCL), or transformations of indolent B-cell lymphomas, according to...
- Patients treated with the commercially available CD19-directed CAR-T products axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel), and who have a partial response at...
- Documented measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2. (Form is available on the Academic and Community Cancer Research United [ACCRU] web site under Study Resources -\> Forms)
- Absolute neutrophil count (ANC) \>= 1,000/mm\^3, granulocyte colony stimulating factor (G-CSF) allowed (obtained =\< 14 days prior to registration)
- Platelet count \>= 50,000/mm\^3 (obtained =\< 14 days prior to registration)
- Hemoglobin \>= 7.0 g/dL if asymptomatic or hemoglobin \> 8 if symptomatic; transfusion support allowed, if necessary (obtained =\< 14 days prior to registration)
- NOTE: symptoms include shortness of breath, fatigue, lightheadedness
- Total bilirubin =\< 1.5 x upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin or lymphoma involvement of the liver and total bilirubin is =\< 5 x ULN (obtained =\< 14...
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 3 x ULN (=\< 5 x ULN for patients with liver involvement) (obtained =\< 14 days prior to registration)
- Calculated creatinine clearance must be \>= 45 mL/min using the Crockcroft- Gault formula (obtained =\< 14 days prior to registration)
- NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the "Lab Test Unit Conversion Worksheet" available on the ACCRU website...
- Negative serum pregnancy test done =\< 7 days prior to registration for a woman of childbearing potential (WOCBP) only
- NOTE: A WOCBP is a sexually mature female who:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- Provide informed written consent =\< 28 days prior to registration
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study, i.e., active treatment and clinical follow-up)
- Willing to provide mandatory tissue specimens and blood specimens for correlative research purposes
What rules you out
- Patients post CAR-T who have bulky disease defined as a disease focus \>= 7.5cm in diameter at day 30 +/- 7 days PET-CT assessment
- Patients post CAR-T who have progressive disease, stable disease or complete response at day 30 +/- 7 days PET-CT assessment based on Lugano criteria
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effect on the developing fetus and newborn are unknown
- Pregnant persons
- Nursing persons
- Persons of childbearing potential who are unwilling to employ adequate contraception (men and women)
- Any of the following prior therapies:
- CD20xCD3 bispecific antibody at any point prior to registration
- CD20-targeted monoclonal antibody (e.g., rituximab, obinutuzumab or biosimilars) =\< 4 weeks prior to registration
- Ongoing cytokine release syndrome (CRS) or neurotoxicity post CAR-T
- Prior grade 4 CRS or neurotoxicity after most recently administered CAR-T
- Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening and based on clinical symptoms, MRI, or lumbar puncture
- Co-morbid systemic illness or other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into the study or interfere significantly with the proper...
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection requiring systemic treatment (excluding prophylactic treatment) =\< 14 days prior to registration, including COVID- 19 infection.
- NOTE: If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable and on suppressive therapy.
- NOTE: If history of treated hepatitis C virus (HCV) infection, HCV viral load must be undetectable.
- NOTE: Patients known to be human immunodeficiency virus (HIV) positive, but stable on anti-retroviral therapy with an undetectable HIV viral load pre-CART, are eligible for this trial.
- NOTE: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment
- NOTE: Past COVID-19 infection may be a risk factor, but if resolved symptoms and the subject is vaccinated, they may be enrolled
- Symptomatic congestive heart failure (New York Heart Association [NYHA] class 3 or 4)
- Unstable angina pectoris
- Unstable cardiac arrhythmia present =\< 14 days prior to registration
- Psychiatric illness/social situations that would limit compliance with study requirement
- History or presence of CNS disorder such as seizure disorder (not including resolved childhood febrile seizures), cerebrovascular ischemia/hemorrhage (not including transient ischemic attacks), cerebellar disease, or...
- Receiving any other investigational agent which would be considered treatment for the primary neoplasm =\< 14 days prior to registration
- Other active malignancy requiring therapy \< 2 years prior to registration (localized non-melanoma skin cancer is allowed)
- Clinically significant cardiovascular disease, including: Myocardial infarction within 1 year prior to randomization, or unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable...
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Salt Lake City, Utah, 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 Rochester, Minnesota, United States; St Louis, Missouri, United States; Hackensack, New Jersey, United States; New York, New York, United States; Chapel Hill, North Carolina, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
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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.