ACTIVE_NOT_RECRUITING

A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Follicular 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

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL). This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone. The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * How the study drug affects quality of life and ability to complete routine daily activities.

Official Title

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)

Quick Facts

Study Start:2023-12-12
Study Completion:2031-11-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06091254

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. 1. Diagnosis of Cluster of Differentiation 20\^+ (CD20\^+) FL Grade 1-3a, stage II bulky or stage III / IV
  2. 2. Need for treatment as described in the protocol
  3. 3. Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
  4. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  5. 5. Adequate bone marrow function and hepatic function, as described in the protocol
  1. 1. Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma
  2. 2. Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
  3. 3. Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
  4. 4. Treatment with any systemic anti-lymphoma therapy
  5. 5. Infections and allergy/hypersensitivity to study drug or excipient, as described in the protocol

Contacts and Locations

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

University of Arizona Cancer Center
Tucson, Arizona, 85724
United States
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
United States
UC Irvine Health
Orange, California, 92868
United States
Investigative Clinical Research of Indiana
Noblesville, Indiana, 46062
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
United States
Icahn School of Medicine at Mt Sinai
New York, New York, 10029
United States
Stony Brook University Hospital
Stony Brook, New York, 11794
United States
Clinical Research Alliance Inc
Westbury, New York, 11590
United States
University of North Carolina
Chapel Hill, North Carolina, 27514
United States
Levine Cancer Institute
Charlotte, North Carolina, 28207
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Center for Oncology and Blood Disorders
Houston, Texas, 77030
United States
HOPE Cancer Center of East Texas
Tyler, Texas, 75701
United States
Huntsman Cancer Institute - Oncology Division
Salt Lake City, Utah, 84112
United States
University of Virginia
Charlottesville, Virginia, 22908
United States
Virginia Commonwealth University
Richmond, Virginia, 23219
United States
Prohealth Care Inc
Waukesha, Wisconsin, 53188
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

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 Date2023-12-12
Study Completion Date2031-11-06

Study Record Updates

Study Start Date2023-12-12
Study Completion Date2031-11-06

Terms related to this study

Keywords Provided by Researchers

  • Non-Hodgkin lymphomas (NHLs)
  • Indolent NHL
  • B-cells NHL (B-NHL)
  • Follicular lymphoma
  • Odronextamab

Additional Relevant MeSH Terms

  • Follicular Lymphoma (FL)