A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma

Conditions

• Relapsed/Refractory Follicular Lymphoma
• Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Odronextamab — DRUG
  Administered per the protocol
• Lenalidomide — DRUG
  Administered per the protocol
• Rituximab — DRUG
  Administered per the protocol

Study Details

This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (called "relapsed"), or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's lymphoma (NHL). This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before. The aim of Part 2, of the study is to assess how well the combination of the study drug and lenalidomide works compared to the combination of rituximab (called "the comparator drug") and lenalidomide. The combination of comparator drug and lenalidomide is the current standard-of-care treatment for relapsed/refractory FL and/or MZL. 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 in combination with lenalidomide * 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

Key Dates

Start date

Dec 28, 2023

Status verified

May 2026

Primary completion

Jan 23, 2029

Completion

Jan 23, 2029

Study Design

Enrollment

470 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Odronextamab+Lenalidomide
  In part 1 (safety run-in), participants with R/R indolent lymphoma (FL and MZL), will receive odronextamab in combination with lenalidomide. In part 2, 1:1 randomized participants with R/R indolent lymphoma (FL/MZL), will receive odronextamab in combination with lenalidomide.
• Experimental: Rituximab+Lenalidomide
  In part 2 only, 1:1 randomized participants with R/R lymphoma (FL and ML), will receive rituximab in combination with lenalidomide (R2) followed by lenalidomide monotherapy.

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs) for odronextamab in combination with lenalidomide [ Time Frame: Up to 35 days ]

Central Contacts

• Clinical Trials Administrator
  844-734-6643
  [email protected]

Locations (8)

Find similar trials in Los Angeles, CA

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