Odronextamab in Low Tumor Volume Advanced FL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGottfried von Keudell, MD PhD
About this trial
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)
Eligibility criteria
Qualifiers
Biopsy-confirmed (fresh or archival tissue) follicular lymphoma grade 1-3A that is CD20+ (by immunophenotype or immunohistochemistry) at time of diagnosis. All degrees of CD20 positivity will be accepted.
Lymph node biopsy obtained in the previous 6 months
Subjects must have measurable disease at time of enrollment as defined by at least one lymph node with long axis ≥1.5 cm
Age ≥18 years
Disqualifiers
Participants must not meet any GELF Criteria for high tumor volume, or other circumstances for which immediate therapy would be indicated
Any nodal or extranodal tumor mass >7 cm diameter
Involvement of at least 3 nodal sites, each with diameter >3 cm
Presence of any systemic or B symptoms for greater than 2 weeks (fever, night sweats, or weight loss)
Trial design
Treatments tested in this trial
- Odronextamab
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Gottfried von Keudell, MD PhD
Lead sponsor
Beth Israel Deaconess Medical Center
Sponsor institution
Regeneron Pharmaceuticals
Collaborator
Source ClinicalTrials.gov