Epcoritamab and Rituximab for First-line Follicular Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorReid Merryman, MD
About this trial
The purpose of this study is to determine how effective and safe the combination of rituximab and epcoritamab is in treating patients with Follicular Lymphoma (FL) and who have not received other treatments for their lymphoma.
The names of the study drugs involved in this study are:
* Rituximab (a type of monoclonal antibody therapy) * Epcoritamab (a T-cell bispecific antibody)
Eligibility criteria
Qualifiers
Histologically confirmed diagnosis of CD20+ FL (grade 1-3A) with review of the diagnostic pathology specimen at one of the participating institutions. Patients with current or prior histologic transformation are excluded.
No prior systemic therapy for FL. Prior treatment with radiation therapy or short course steroids is allowed.
Symptomatic adenopathy
Organ function impairment due to disease involvement, including cytopenias due to marrow involvement (WBC <1.5x109/L; absolute neutrophil count [ANC] <1.0x109/L, Hgb <10g/dL; or platelets <100x109/L)
Disqualifiers
Patients who require systemic immunosuppressive therapy for an ongoing medical condition will be excluded. For corticosteroids, patients receiving a prednisone dose of >10 mg daily (or equivalent) will not be eligible. A short course of steroids (up to 14 days) for symptom palliation is allowed, in which case patients should be off steroids prior to treatment start.
Patients with bulky cervical adenopathy that is compressing the upper airway or could result in significant airway compression during a tumor flare event.
Patients with stage I follicular lymphoma
Patients who are candidates for radiation therapy with curative intent (in the opinion of the treating investigator)
Trial design
Treatments tested in this trial
- Epcoritamab
- Rituximab
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Reid Merryman, MD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Genmab
Collaborator
AbbVie
Collaborator
Source ClinicalTrials.gov