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NCT Number: NCT03888105

A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies

This study is researching an investigational drug, odronextamab, in adult patients B-cell non-Hodgkin's lymphoma (B-NHL).

The main purpose of this study is to assess the effectiveness of odronextamab in destroying cancer cells and to learn more about the safety of odronextamab.

The study is looking at several other research questions, including:

* To see if odronextamab works to destroy cancer cells * Side effects that may be experienced by people taking odronextamab * How odronextamab works in the body * How much odronextamab is present in the blood

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Border Medical Oncology, East Albury, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment

  • FL grade 1-3a cohort: Patients with FL grade 1-3a 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: Patients with MCL who have relapsed or refractory disease to at least one prior line of systemic therapy and had prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor
  • 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.
  • 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, up to 12 months prior to first administration of study drug. The presence of acute or chronic graft-versus host disease (GVHD) will also be an exclusion
  • 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

Treatment and study plan

Odronextamab

Drug

Administered by intravenous (IV) infusion

Other names: REGN1979

Primary outcomes

  1. Objective Response Rate (ORR), as assessed by independent central review

    Time frame: Up to 52 weeks of study treatment

    FL grade 1-3a/MZL

  2. ORR, as assessed by independent central review

    Time frame: Up to 36 weeks of study treatment

    DLBCL/MCL/Other B-NHL

Secondary outcomes

  1. ORR, as assessed by the local investigator

    Time frame: Up to 52 weeks of study treatment

    FL/MZL

  2. ORR, as assessed by the local investigator

    Time frame: Up to 36 weeks of study treatment

    DLBCL/MCL/Other B-NHL

  3. Complete Response (CR) Rate, as assessed by the local investigator

    Time frame: Up to 52 weeks of study treatment

    FL grade 1-3a/MZL

  4. CR rate, as assessed by independent central review

    Time frame: Up to 52 weeks of study treatment

    FL grade 1-3a/MZL

  5. CR rate, as assessed by the local investigator

    Time frame: Up to 36 weeks of study treatment

    DLBCL/MCL/Other B-NHL

  6. CR rate, as assessed by independent central review

    Time frame: Up to 36 weeks of study treatment

    DLBCL/MCL/Other B-NHL

  7. Progression-Free Survival (PFS), as assessed by independent central review

    Time frame: Approximately 194 weeks following the first dose

  8. PFS, as assessed by the local investigator

    Time frame: Approximately 194 weeks following the first dose

  9. Overall Survival (OS)

    Time frame: Approximately 194 weeks following the first dose

  10. Duration Of Response (DOR), as assessed by independent central review

    Time frame: Approximately 194 weeks following the first dose

  11. DOR, as assessed by the local investigator

    Time frame: Approximately 194 weeks following the first dose

  12. Disease Control Rate (DCR), as assessed by independent central review

    Time frame: Up to 52 weeks of study treatment

    FL grade 1-3a/MZL

  13. DCR, as assessed by the local investigator

    Time frame: Up to 52 weeks of study treatment

    FL grade 1-3a/MZL

  14. DCR, as assessed by independent central review

    Time frame: Up to 36 weeks of study treatment

    DLBCL/MCL/Other B-NHL

  15. DCR, as assessed by the local investigator

    Time frame: Up to 36 weeks of study treatment

    DLBCL/MCL/Other B-NHL

  16. Incidence and severity of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Approximately 194 weeks following the first dose

  17. Concentration of odronextamab

    Time frame: 12 weeks following end of treatment

    End of infusion [EOI]; Concentration at a specified time t [Ct])

  18. Incidence of Anti-Drug Antibodies (ADA) to odronextamab over time

    Time frame: 12 weeks following end of treatment

  19. Titer of anti-drug antibodies to odronextamab over time

    Time frame: 12 weeks following end of treatment

  20. Incidence of Neutralizing antibodies (Nab) to odronextamab over time

    Time frame: 12 weeks following end of treatment

  21. Changes in scores of patient-reported outcomes as measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC-QLQ-C30)

    Time frame: Approximately 194 weeks following the first dose

    The EORTC QLQ-C30 is a self-reported, 30-item generic questionnaire developed to assess 15 domains: global health status scale, five functional scales (physical, role, emotional, cognitive, and social functioning) and nine symptom scales (fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties).

  22. Changes in scores of patient-reported outcomes as measured by Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym)

    Time frame: Approximately 194 weeks following the first dose

    Composed of the FACT-G plus the 15-item Lymphoma Subscale (LymS).

  23. Changes in scores of patient-reported outcomes as measured by EuroQol-5 Dimensions-3 Levels (EQ-5D-3L)

    Time frame: Approximately 194 weeks following the first dose

    The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Acronym: ELM-2

Important dates

Study start
2019
Primary completion
2026
Study completion
2028
First posted
Mar 25, 2019
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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