ClinicalTrials.Veeva

Menu
The trial is taking place at:
H

Hospital Costa del Sol | Internal Medicine

Veeva-enabled site

A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With B-cell Non-Hodgkin Lymphoma That Have Been Previously Treated (ELM-2)

Regeneron Pharmaceuticals logo

Regeneron Pharmaceuticals

Status and phase

Enrolling
Phase 2

Conditions

B-cell Non-Hodgkin Lymphoma (NHL)

Treatments

Drug: Odronextamab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03888105
R1979-ONC-1625
2017-002139-41 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

512 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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: Patients with MZL that have relapsed or is refractory to at least 2 prior lines of systemic therapy.
  • 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

Key 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; cytomegalovirus (CMV) infection as noted by detectable levels on a blood polymerase chain reaction (PCR) assay as defined in the protocol or other uncontrolled infections
  • 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

512 participants in 5 patient groups

FL
Experimental group
Description:
Follicular lymphoma grade 1-3a cohort
Treatment:
Drug: Odronextamab
DLBCL
Experimental group
Description:
Diffuse large B-cell lymphoma cohort
Treatment:
Drug: Odronextamab
MCL
Experimental group
Description:
Mantle Cell Lymphoma cohort
Treatment:
Drug: Odronextamab
MZL
Experimental group
Description:
Marginal Zone Lymphoma cohort
Treatment:
Drug: Odronextamab
Other B-NHL
Experimental group
Description:
Other B-cell non-Hodgkin lymphoma cohort (excluding FL Grade 1-3a, DLBCL, MCL, MZL, Waldenström macroglobulinemia [WM]); Patients with a current diagnosis of mixed histology of B-NHL with an aggressive component (such as concurrent FL and DLBCL) will be allowed
Treatment:
Drug: Odronextamab

Trial contacts and locations

138

Loading...

Central trial contact

Clinical Trials Administrator

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems