TREND-FL: Tafasitamab and Rituximab to Enhance Outcomes in Patients With Newly Diagnosed Follicular Lymphoma
University of Washington
Summary
This phase II trial tests how well tafasitamab and rituximab works for the treatment of newly diagnosed follicular lymphoma. Tafasitamab is a monoclonal antibody. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving tadasitamab and rituximab may work well to treat patients with newly diagnosed follicular lymphoma.
Description
OUTLINE: CYCLES 1-3: Patients receive rituximab intravenously (IV) on day 1 and tafasitamab IV on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. CYCLES 4-6; Patients receive rituximab IV on day 1 and tafasitamab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo disease assessment. Patients with complete response undergo active surveillance. Patients with less than complete response go on to receive cycles 7-12. C…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years old * Patients must have histologic confirmation of follicular lymphoma (FL) (grade 1, 2, and 3A or classic follicular lymphoma) * Meeting any one of the following criteria for therapy initiation: * Involvement of ≥ 3 nodal sites, each with diameter of ≥ 3 cm. * Any nodal or extranodal tumor mass with a diameter of ≥ 7 cm. * B symptoms (fever ≥ 38 degrees Celsius of unclear etiology, night sweats, weight loss \> 10% within the prior 6 months) attributed to FL. * Risk of local compressive symptoms that may result in organ compromise. * Splenomega…
Interventions
- BiologicalRituximab
Given IV
- BiologicalTafasitamab
Given IV
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy
- ProcedureComputed Tomography
Undergo CT scan
- ProcedurePositron Emission Tomography
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington