Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

  • STATUS
    Recruiting
  • End date
    Dec 15, 2028
  • participants needed
    512
  • sponsor
    Regeneron Pharmaceuticals
Updated on 2 August 2021
renal function
cancer
measurable disease
follicular lymphoma
diffuse large b-cell lymphoma
b-cell lymphoma
mantle cell lymphoma
refractory b-cell non-hodgkin lymphoma
alkylating agent
marginal zone lymphoma
large b-cell lymphoma
tositumomab
btk inhibitor

Summary

Primary objective is to assess the anti-tumor activity of single agent odronextamab as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review in each of the following B-cell non-Hodgkin lymphoma (B-NHL) subgroups:

  • In patients with follicular lymphoma (FL) grade 1-3a *1,2
  • In patients with diffuse large B-cell lymphoma (DLBCL) *1,2
  • In patients with mantle cell lymphoma (MCL) that has relapsed after or is refractory to a BTK inhibitor. This cohort will also include patients who have relapsed or have disease refractory to prior systemic therapy, or patients who have demonstrated intolerance to BTK inhibitor therapy, and who have progressed after other systemic therapy.
  • In patients with marginal zone lymphoma (MZL) *1
  • In patients with other B-NHL subtypes *1

Secondary objectives are:

  • To assess the anti-tumor activity of single agent odronextamab in each of 5 disease-specific cohorts, as measured by:
  • ORR according to the Lugano Classification and as assessed by local investigator evaluation
  • Complete response (CR) rate according to the Lugano Classification and as assessed local by local investigator evaluation and independent central review
  • Progression-free survival (PFS)*3
  • Overall survival (OS)
  • Duration of response (DOR)*3
  • Disease control rate (DCR)*3
  • To evaluate the safety and tolerability of odronextamab
  • To assess the pharmacokinetics (PK) of odronextamab
  • To assess the immunogenicity of odronextamab
  • To assess the effect of odronextamab on patient reported outcomes, including health-related quality of life (HRQL), as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym), and EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L)
  • 1 that has relapsed after or is refractory to at least 2 prior lines of systemic therapy
  • 2 including an anti-CD20 antibody and an alkylating agent
  • 3 according to Lugano Classification and as assessed by independent central review and local investigator evaluation

Details
Condition Follicular Lymphoma, Lymphoma, B-Cell Lymphoma, Non-Hodgkin's Lymphoma, Lymphoma, B-Cell
Treatment REGN1979, Odronextamab
Clinical Study IdentifierNCT03888105
SponsorRegeneron Pharmaceuticals
Last Modified on2 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the "other B-NHL" cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017)
Disease-specific cohorts that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
MCL after BTK inhibitor therapy cohort: New enrollment is paused until further notice
MZL cohort: New enrollment is paused until further notice
Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol. New enrollment stopped for patients with Burkitt lymphoma and Burkitt-like lymphoma
Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment
Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI))
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate bone marrow, hepatic, and renal function as defined in the protocol

Exclusion Criteria

Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI)
Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter
History of allogeneic stem cell transplantation
Prior treatment with any chimeric antigen receptor T-cell (CAR-T) therapy
Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug
History of neurodegenerative condition or CNS movement disorder. Patients with a history of seizure within 12 months prior to study enrollment are excluded
Another malignancy except B-NHL in the past 5 years, with the exception of non-melanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or other uncontrolled infection as defined in the protocol
Known hypersensitivity to both allopurinol and rasburicase
Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy
Note: Other protocol-defined Inclusion/Exclusion criteria apply
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