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

Condition(s) studied

Investigational drug(s) / intervention(s)

Odronextamab: Administered by intravenous (IV) infusion

Ifosfamide: Administered by IV infusion, as part of the ICE ± R salvage therapy

Carboplatin: Administered by IV infusion, as part of the ICE ± R salvage therapy

Etoposide: Administered by IV infusion, as part of the ICE ± R salvage therapy

Rituximab: Administered by IV infusion, as part of the ICE ± R, or DHAP ± R, or GDP ± R salvage therapy.

Dexamethasone: Administered by IV, or orally (PO) as part of the DHAP ± R, or GDP ± R salvage therapy.

Cisplatin: Administered by IV infusion, as part of the DHAP ± R or GDP +/-R salvage therapy.

Cytarabine: Administered by IV infusion, as part of the DHAP ± R salvage therapy.

Gemcitabine: Administered by IV infusion, as part of the GDP ± R salvage therapy.

Study summary

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

Eligibility

Primary outcome measure(s)

• Event-free survival (EFS) as assessed by independent central review (ICR) — Assessed up to 3 years

Trial sites (81)

+ 41 more sites — see the full list on the official registry below.

On this site

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