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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Epcoritamab
DrugT-cell bispecific antibody, via subcutaneous injection
Rituximab
DrugChimeric anti-CD20 monoclonal antibody, via IV infusion
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Epcoritamab + RituximabExperimental treatment 2 interventions
Group B: Epcoritamab + Rituximab ExpansionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
End of Treatment (EOT) Complete Metabolic Response (CMR) Rate
EOT CMR rate defined as the proportion of participants achieving CR per PET/CT Lugano 2014 criteria (protocol appendix B) at the EOT assessment: PET-CT, score 1, 2, or 3 with or without a residual mass on a 5-point scale (5PS) among all patients and separately in Cohorts A and B.
Time frame
(Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 daysSecondary outcomes
1
Best Partial Metabolic Response (PMR) Rate
Best PMR rate defined as the proportion of participants achieving PR per Lugano 2014 criteria (protocol appendix B) ever on treatment: PET-CT Score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size or on CT, ≥ 50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; no increase in non-measured lesions; spleen if enlarged must have regressed by \>50% in length beyond normal.
Time frame
(Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days2
Best Objective Metabolic Response (OMR) Rate
Best OMR rate defined as the proportion of participants achieving CR or partial response (PR) per Lugano 2014 criteria (protocol appendix B) ever on treatment.
Time frame
(Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days3
EOT Partial Metabolic Response (PMR) Rate
EOT PMR rate defined as the proportion of participants achieving PR per PET/CT Lugano 2014 criteria (protocol appendix B) at the EOT assessment: PET-CT Score 4 or 5 with reduced uptake compared with baseline and residual mass(es).
Time frame
(Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days4
EOT Objective Metabolic Response (OMR) Rate
EOT OMR rate defined as the proportion of participants achieving CR or partial response (PR) per PET/CT Lugano 2014 criteria (protocol appendix B) at the EOT assessment.
Time frame
(Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Reid Merryman, MD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Genmab
Collaborator
AbbVie
Collaborator
Source ClinicalTrials.gov