A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma

Condition(s) studied

Investigational drug(s) / intervention(s)

Odronextamab: Administered by intravenous (IV) infusion

Rituximab: Administered by IV infusion, or subcutaneous (SC)

Cyclophosphamide: Administered by IV infusion

Doxorubicin: Administered by IV infusion

Vincristine: Administered by IV infusion

Prednisone/Prenisolone: Administered orally (PO)

Study summary

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with follicular lymphoma that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory") are eligible to take part only in Part 1A of the study.

This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2 (randomized - controlled).

The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy to be used in Part 2 of the study.

The aim of Part 2 of the study is to assess how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab and chemotherapy (the current standard-of-care for NHL). Standard-of-care means the usual medication expected and used when receiving treatment for a condition.

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

* What side effects may happen from taking the study drug
* 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)
* The impact from the study drug on quality-of-life and ability to complete routine daily activities

Eligibility

Primary outcome measure(s)

• Incidence of dose limiting toxicities (DLTs) for odronextamab in combination with chemotherapy — Up to 35 days
  Part 1, DLT period
• Incidence of treatment-emergent adverse events (TEAEs) of odronextamab in combination with chemotherapy — Up to 2 years
  Part 1, Treatment period
• Severity of TEAEs of odronextamab in combination with chemotherapy — Up to 2 years
  Part 1, Treatment period
• Complete Response rate at 30 months (CR30) assessed by independent central review (ICR) — Up to 30 months
  Part 2

Trial sites (145)

+ 105 more sites — see the full list on the official registry below.