Testing a new drug called odronextamab for treating follicular lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and effectiveness of odronextamab, an experimental drug, in patients with previously untreated follicular lymphoma. The study consists of two parts: the first part assesses the safety and tolerability of odronextamab alone, while the second part compares its effectiveness to the standard treatment of rituximab combined with chemotherapy. Participants will be monitored for side effects, drug levels in the blood, and the body's immune response to the drug. The goal is to determine if odronextamab can provide a better treatment option for this type of cancer.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Diagnosis of Cluster of Differentiation 20\^+ (CD20\^+) FL Grade 1-3a, stage II bulky or stage III / IV
2. Need for treatment as described in the protocol
3. Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
5. Adequate bone marrow function and hepatic function, as described in the protocol

Key Exclusion Criteria:

1. Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma
2. Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
3. Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
4. Treatment with any systemic anti-lymphoma therapy
5. Infections and allergy/hypersensitivity to study drug or excipient, as described in the protocol

NOTE: Other protocol defined inclusion/exclusion criteria apply

Where it's running

• University of Arizona Cancer Center
  Tucson, Arizona, United States Recruiting
• David Geffen School of Medicine at UCLA
  Los Angeles, California, United States Recruiting
• Investigative Clinical Research of Indiana
  Noblesville, Indiana, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• Karmanos Cancer Institute
  Detroit, Michigan, United States Recruiting
• Icahn School of Medicine at Mt Sinai
  New York, New York, United States Recruiting

+140 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Testing a new drug combination for relapsed or refractory follicular and marginal zone lymphoma

  This study is testing a new combination of drugs to see if it can help adults with relapsed or hard-to-treat follicular or marginal zone lymphoma feel better compared to standard treatment.

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• Odronextamab with chemo vs rituximab with chemo in untreated DLBCL

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  Recruiting at 182 sites Phase 3 Regeneron Pharmaceuticals · Scottsdale, Arizona and 194 other locations · NCT06091865

• Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.