Actively Recruiting
Odronextamab in Low Tumor Volume Advanced FL
Led by Gottfried von Keudell, MD PhD · Updated on 2026-03-13
35
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
Sponsors
G
Gottfried von Keudell, MD PhD
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and effectiveness of treating previously untreated Follicular Lymphoma (FL) with odronextamab. The name of the study drug in this research study is: -Odronextamab (a type of monoclonal antibody)
CONDITIONS
Official Title
Odronextamab in Low Tumor Volume Advanced FL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-confirmed follicular lymphoma grade 1-3A that is CD20 positive
- Lymph node biopsy obtained within the previous 6 months
- Measurable disease with at least one lymph node 1.5 cm in long axis
- Age 18 years or older
- ECOG performance status less than or equal to 2
- Life expectancy greater than 2 years
- Adequate organ and marrow function with specific blood counts and liver, kidney, and heart function requirements
- Controlled hepatitis B or C infection with appropriate antiviral therapy if applicable
- Women of childbearing potential must agree to use highly effective contraception before, during, and for 6 months after treatment
- Men must agree to use medically acceptable birth control during the study and for 6 months after the last dose
- Ability to understand and sign informed consent
You will not qualify if you...
- Meeting any GELF criteria for high tumor volume or needing immediate therapy
- Tumor mass larger than 7 cm diameter or involvement of 3 or more nodal sites each larger than 3 cm
- Presence of systemic or B symptoms lasting more than 2 weeks
- Splenic enlargement below the umbilical line
- Compression syndromes affecting organs
- Presence of pleural or peritoneal effusion
- Leukemic phase with more than 5.0 x10^9/L circulating malignant cells
- Cytopenia with low granulocyte or platelet counts
- Active infections requiring treatment or uncontrolled viral infections including HIV, hepatitis B or C
- Another active cancer within the past 2 years except certain treated cancers
- Limited-stage follicular lymphoma treatable with curative intent using radiotherapy
- Duodenal follicular lymphoma or spontaneous regression before treatment
- Prior systemic therapy or radiation therapy except specific low dose radiotherapy completed at least 12 weeks earlier
- Uncontrolled cardiac or neurologic conditions
- Immunosuppressive therapy within 28 days before treatment
- Known or suspected CNS involvement
- History of neurodegenerative or CNS movement disorders, recent seizures
- Pregnant or unwilling to use contraception during and for 12 months after treatment
- Known alcohol or drug abuse or psychiatric illness limiting compliance
- Known allergies to allopurinol or rasburicase or hypersensitivity to similar compounds
- Recent exposure to live or live attenuated vaccines within 4 weeks
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
G
Gottfried Von Keudell, MD, PhD
CONTACT
D
Dea Hunsicker, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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