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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Odronextamab
Biological/VaccineA CD20xCD3 bispecific monoclonal antibody, glass vials, via intravenous (into the vein) infusion per protocol.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: OdronextamabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete Response Rate (CRR)
CRR is defined as the proportion of patients who accomplish a complete response (CR) as best response (CR rate) following treatment with odronextamab as per the revised Lugano criteria.
Time frame
Assessed at baseline and every 3 cycles, treatment lasts for 6 cycles, each cycle is 21 days.Secondary outcomes
1
Overall Response Rate (ORR)
ORR is defined as the proportion of participants that experience complete response (CR) or partial response (PR) during treatment as per the revised Lugano criteria.
Time frame
Assessed at baseline and every 3 cycles, treatment lasts for 6 cycles, each cycle is 21 days.2
Median Progression Free Survival (PFS)
Progression-Free Survival (PFS) based on Kaplan-Meier method is defined as the time from treatment start to either disease progression or death due to any cause (whichever occurs first). Participants alive without disease progression are censored at date of last disease evaluation.
Time frame
Every 9 weeks in the first 18 weeks, then every 3 months for 2 years, then annually through year 5.3
Median Overall Survival (OS)
OS is Overall survival based on the Kaplan-Meier method is defined as the time from randomization to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant.
Time frame
Every 9 weeks in the first 18 weeks, then every 3 months for 2 years, then annually through year 15.4
Median time to next treatment (TTNT)
TTNT is defined as is defined as the time from treatment start until date of initiation of next line of treatment.
Time frame
Treatment lasts for 6 cycles, each cycle is 21 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Gottfried von Keudell, MD PhD
Lead sponsor
Beth Israel Deaconess Medical Center
Sponsor institution
Regeneron Pharmaceuticals
Collaborator
Source ClinicalTrials.gov