RECRUITING

Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy

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Conditions

Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedPrimary Mediastinal Large B-Cell LymphomaTransformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. It works by simultaneously attaching to a molecule called CD20 on cancerous B-cells and a molecule called CD3 on effector T-cells, which are a type of immune cell. When epcoritamab binds to CD20 and CD3, it brings the two cells together and activates the T-cells to kill the cancerous B-cells. Epcoritamab may increase a patient's chances of achieving complete remission after CD19-directed CAR-T therapy, compared to standard observation.

Official Title

Multicenter, Randomized Phase II Study of Epcoritamab for Patients With Aggressive B-Cell Lymphomas Achieving a Partial Response After CD19-Directed CAR-T Therapy

Quick Facts

Study Start:2024-01-31
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06238648

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women \>= 18 years of age
  2. * 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 the 5th edition of World Health Organization (WHO) classification of lymphoid neoplasms, with CD20 positivity as determined by assessment of tumor cells =\< 6 months prior to registration pre- CAR-T biopsy specimen by immunohistochemistry or flow cytometry
  3. * 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 day 30 +/- 7 days PET- CT assessment based on Lugano criteria (Deauville score of 4 or 5)
  4. * Documented measurable disease
  5. * 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)
  6. * Absolute neutrophil count (ANC) \>= 1,000/mm\^3, granulocyte colony stimulating factor (G-CSF) allowed (obtained =\< 14 days prior to registration)
  7. * Platelet count \>= 50,000/mm\^3 (obtained =\< 14 days prior to registration)
  8. * Hemoglobin \>= 7.0 g/dL if asymptomatic or hemoglobin \> 8 if symptomatic; transfusion support allowed, if necessary (obtained =\< 14 days prior to registration)
  9. * NOTE: symptoms include shortness of breath, fatigue, lightheadedness
  10. * 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 days prior to registration)
  11. * Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 3 x ULN (=\< 5 x ULN for patients with liver involvement) (obtained =\< 14 days prior to registration)
  12. * Calculated creatinine clearance must be \>= 45 mL/min using the Crockcroft- Gault formula (obtained =\< 14 days prior to registration)
  13. * 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 under "General Forms."
  14. * Negative serum pregnancy test done =\< 7 days prior to registration for a woman of childbearing potential (WOCBP) only
  15. * NOTE: A WOCBP is a sexually mature female who:
  16. * Has not undergone a hysterectomy or bilateral oophorectomy; or
  17. * 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)
  18. * Provide informed written consent =\< 28 days prior to registration
  19. * 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)
  20. * Willing to provide mandatory tissue specimens and blood specimens for correlative research purposes
  1. * 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
  2. * 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
  3. * 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
  4. * Pregnant persons
  5. * Nursing persons
  6. * Persons of childbearing potential who are unwilling to employ adequate contraception (men and women)
  7. * Any of the following prior therapies:
  8. * CD20xCD3 bispecific antibody at any point prior to registration
  9. * CD20-targeted monoclonal antibody (e.g., rituximab, obinutuzumab or biosimilars) =\< 4 weeks prior to registration
  10. * Ongoing cytokine release syndrome (CRS) or neurotoxicity post CAR-T
  11. * Prior grade 4 CRS or neurotoxicity after most recently administered CAR-T
  12. * Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening and based on clinical symptoms, MRI, or lumbar puncture
  13. * 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 assessment of safety and toxicity of the prescribed regimens
  14. * Uncontrolled intercurrent illness including, but not limited to:
  15. * Ongoing or active infection requiring systemic treatment (excluding prophylactic treatment) =\< 14 days prior to registration, including COVID- 19 infection.
  16. * NOTE: If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable and on suppressive therapy.
  17. * NOTE: If history of treated hepatitis C virus (HCV) infection, HCV viral load must be undetectable.
  18. * 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.
  19. * NOTE: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment
  20. * NOTE: Past COVID-19 infection may be a risk factor, but if resolved symptoms and the subject is vaccinated, they may be enrolled
  21. * Symptomatic congestive heart failure (New York Heart Association \[NYHA\] class 3 or 4)
  22. * Unstable angina pectoris
  23. * Unstable cardiac arrhythmia present =\< 14 days prior to registration
  24. * Psychiatric illness/social situations that would limit compliance with study requirement
  25. * 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 any autoimmune disease with CNS involvement
  26. * Receiving any other investigational agent which would be considered treatment for the primary neoplasm =\< 14 days prior to registration
  27. * Other active malignancy requiring therapy \< 2 years prior to registration (localized non-melanoma skin cancer is allowed)
  28. * 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 angina, congestive heart failure, New York Heart Association class III-IV) cardiac arrhythmia (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0 grade 2 or higher), or clinically significant electrocardiogram (ECG) abnormalities

Contacts and Locations

Principal Investigator

Grzegorz S Nowakowski
PRINCIPAL_INVESTIGATOR
Academic and Community Cancer Research United

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Siteman Cancer Center at Washington University
Saint Louis, Missouri, 63110
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Academic and Community Cancer Research United

  • Grzegorz S Nowakowski, PRINCIPAL_INVESTIGATOR, Academic and Community Cancer Research United

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-31
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2024-01-31
Study Completion Date2030-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Primary Mediastinal Large B-Cell Lymphoma
  • Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma