RECRUITING

A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma

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

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 496 adult participants with NHL will be enrolled in 100 sites globally. In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28 day, 21 day, or 56 day cycles dependent on the arm in combination with the anti-neoplastic agents described below: 1: Oral lenalidomide in participants (PPTS) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in PPTS with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in PPTS with newly diagnosed treatment-naïve DLBCL, or completion of treatment in 3B; 4: Oral CC-99282 in PPTS with R/R DLBCL; 5: Oral CC-99282 in PPTS with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in PPTS with R/R mantle cell lymphoma (MCL). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Official Title

Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma

Quick Facts

Study Start:2022-06-14
Study Completion:2032-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05283720

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. * Diagnosis of:
  2. * DLBCL, not otherwise specified (NOS).
  3. * High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per WHO 2016 ("double-hit" or "triple-hit") Note: High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible.
  4. * Follicular lymphoma (FL) Grade 3B. OR
  5. * FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR
  6. * Mantle cell lymphoma (MCL) with histologically confirmed CD20+ disease at most recent representative tumor biopsy according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR).
  7. * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2, except for Arm 6A where ECOG performance status must be 0-1.
  8. * Must have 1 or more measurable disease sites:
  9. * A positron emission tomography (PET) /computed tomography (CT) scan demonstrating PET-positive lesion(s) AND
  10. * At least 1 measurable nodal lesion (long axis \> 1.5 cm) or \>= 1 measurable extra-nodal lesion (long axis \> 1.0 cm) on CT scan or magnetic resonance imaging (MRI).
  1. * Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20.
  2. * Toxicities from prior anticancer therapy that have not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia. Other eligibility criteria (e.g., laboratory, cardiac criteria) must also be met.

Contacts and Locations

Study Contact

ABBVIE CALL CENTER
CONTACT
844-663-3742
abbvieclinicaltrials@abbvie.com

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

The University of Arizona Cancer Center - North Campus /ID# 242219
Tucson, Arizona, 85719
United States
Yale University School of Medicine /ID# 242089
New Haven, Connecticut, 06510
United States
Christiana Care Health Service /ID# 242301
Newark, Delaware, 19713
United States
Tampa General Hospital /ID# 246748
Tampa, Florida, 33606
United States
Winship Cancer Institute of Emory University /ID# 242153
Atlanta, Georgia, 30322
United States
University of Maryland, Baltimore /ID# 242218
Baltimore, Maryland, 21201
United States
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144
Kansas City, Missouri, 64114-4859
United States
Northwell Health - Monter Cancer Center /ID# 245435
Lake Success, New York, 11042
United States
Icahn School of Medicine at Mount Sinai /ID# 242123
New York, New York, 10029
United States
Novant Health Presbyterian Medical Center /ID# 242148
Charlotte, North Carolina, 28204
United States
East Carolina University - Brody School of Medicine /ID# 242506
Greenville, North Carolina, 27834
United States
Novant Health Forsyth Medical Center /ID# 242198
Winston-Salem, North Carolina, 27103
United States
Thomas Jefferson University Hospital /ID# 242077
Philadelphia, Pennsylvania, 19107
United States
Fox Chase Cancer Center /ID# 242106
Philadelphia, Pennsylvania, 19111
United States
Thompson Cancer Survival Ctr /ID# 242150
Knoxville, Tennessee, 37916
United States
Joe Arrington Cancer Research /ID# 242226
Lubbock, Texas, 79410
United States
Swedish Cancer Institute /ID# 242269
Seattle, Washington, 98104-3588
United States
MultiCare Institute for Research & Innovation /ID# 242127
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Genmab

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

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 Date2022-06-14
Study Completion Date2032-11

Study Record Updates

Study Start Date2022-06-14
Study Completion Date2032-11

Terms related to this study

Keywords Provided by Researchers

  • Non-Hodgkin Lymphoma
  • Epcoritamab
  • Lenalidomide
  • Ibrutinib
  • Polatuzumab Vedotin
  • Rituximab
  • Cyclophosphamide
  • Doxorubicin Hydrochloride (HCl]
  • Prednisone (pola-R-CHP)
  • ABBV-GMAB-3013
  • Cancer
  • Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL), Venetoclax,
  • Venclexta
  • ABT-199
  • GDC-0199
  • CC-99282
  • EPCORE
  • Pirtobrutinib
  • Mantle Cell Lymhoma

Additional Relevant MeSH Terms

  • Non-Hodgkin Lymphoma