A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06230224
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • B-Cell Non-Hodgkin Lymphoma (B-NHL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Odronextamab — DRUG
    Administered by intravenous (IV) infusion
  • Ifosfamide — DRUG
    Administered by IV infusion, as part of the ICE ± R salvage therapy
  • Carboplatin — DRUG
    Administered by IV infusion, as part of the ICE ± R salvage therapy
  • Etoposide — DRUG
    Administered by IV infusion, as part of the ICE ± R salvage therapy
  • Rituximab — DRUG
    Administered by IV infusion, as part of the ICE ± R, or DHAP ± R, or GDP ± R salvage therapy.
  • Dexamethasone — DRUG
    Administered by IV, or orally (PO) as part of the DHAP ± R, or GDP ± R salvage therapy.
  • Cisplatin — DRUG
    Administered by IV infusion, as part of the DHAP ± R or GDP +/-R salvage therapy.
  • Cytarabine — DRUG
    Administered by IV infusion, as part of the DHAP ± R salvage therapy.
  • Gemcitabine — DRUG
    Administered by IV infusion, as part of the GDP ± R salvage therapy.

Study Details

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients with previously treated aggressive B-cell non-Hodgkin lymphoma whose cancer has stopped responding to treatment (also known as 'refractory') or has returned (also known as 'relapsed'). The aim of the study is to see how safe, tolerable and effective the study drug is when given alone. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug versus Standard of Care (SOC) * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * Comparing the impact from the study drug versus SOC on quality-of-life and ability to complete routine daily activities

Key Dates

Start date
Feb 15, 2024
Status verified
May 2026
Primary completion
May 29, 2028
Completion
May 29, 2029

Study Design

Enrollment
216 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Odronextamab
    Participants will receive odronextamab monotherapy.
  • Active Comparator: Standard Of Care
    Participants will receive salvage therapy (ifosfamide, carboplatin, etoposide ± rituximab \[ICE ± R\], or dexamethasone, cisplatin, cytarabine ± rituximab \[DHAP ± R\], or gemcitabine, dexamethasone, cisplatin ± rituximab \[GDP ± R\]) and continue with autologous stem cell transplant (ASCT) following a complete response (CR)/partial response (PR).

Primary Outcome Measure

Event-free survival (EFS) as assessed by independent central review (ICR) [ Time Frame: Assessed up to 3 years ]

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