Study Details

Open

Untreated Follicular Lymphoma Study

The study is researching an experimental drug called odronextamab. The study is for patients with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma). In this study, we want to find out more about how safe and tolerable the study drug is. We will also compare how well the study drug orks compared to rituximab and chemotherapy (the current standard of care for NHL).

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

If you decide to take part, you will receive course of either the study drug (odronextamab) or the standard of care chemotherapy and rituximab once every 3 weeks for 6 weeks (18 weeks total). You will then receive maintenance treatment, consisting of odronextamab or rituximab for up to a year. You also will be asked to complete questionnaires and have some tests like a CT, PET scan, and an MRI. We also may take biopsies or your lymph nodes or bone marrow. Once the study treatment is over, you will return for follow up visits to UNC every 3 months until either the study is completed, you start another treatment, or decide to withdraw from the study.

Incentives

Study drug is provided by the sponsor. Optional travel Reimbursement and a 75$ stipend per treatment visit is available.

In-person visits:
15-50

Phone or online visits:
15-50

Total length of participation:
Between 18 weeks - one year or more

Looking for Specific Volunteers

Able to participate:

You have been diagnosed with untreated follicular lymphoma
You have adequate bone marrow and liver function
You are willing and able to attend the required clinic visits and complete study-related procedures
You have been cancer free for at least the past 3 years (some exceptions)
You have not had an organ transplant

Not eligible if:

You have CNS (central nervous system) lymphoma or leptomeningeal lymphoma
You have had any prior therapy to treat your lymphoma
You require continuous corticosteroid treatment, an cannot stop for at least 3 days before taking the study drug
Any active disease or medical condition that would put you at significantly increased risk in the study

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Natalie Grover
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Lymphoma)

IRB Number

23-1232