Study on Tafasitamab and Rituximab for Treating Newly Diagnosed Follicular Lymphoma

Sponsor: University of Washington

Sponsor score: 40

ClinicalTrials ID:NCT07731789

Provider View

This clinical trial is exploring how well the combination of two drugs, tafasitamab and rituximab, works in treating patients who have been newly diagnosed with follicular lymphoma, a type of blood cancer.

Patient Parameters

Program Overview

This study is testing a treatment for newly diagnosed follicular lymphoma using two drugs: tafasitamab and rituximab. Both drugs are monoclonal antibodies, which are proteins designed to target specific molecules in the body. Rituximab targets a protein called CD20 found on certain white blood cells and cancer cells, helping the immune system to destroy them. The study aims to see if using these drugs together can effectively treat follicular lymphoma.

Description

The study is structured in cycles, with each cycle lasting 28 days.

CYCLES 1-3: Patients receive rituximab through an IV on day 1 and tafasitamab through an IV on days 1, 8, 15, and 22 of each cycle. This continues unless the disease worsens or side effects become too severe.

CYCLES 4-6: Patients continue with rituximab on day 1 and tafasitamab on days 1 and 15 of each cycle, again repeating every 28 days unless there are issues.

After these cycles, doctors will assess the disease. If the cancer is completely gone, patients will be monitored closely. If not, patients will continue with more cycles.

CYCLES 7-12: Patients receive tafasitamab on days 1 and 15 of each cycle, repeating every 28 days unless there are problems.

Throughout the study, patients will have various tests, including PET and CT scans, bone marrow biopsies, and blood tests to monitor their condition.

After finishing the treatment, patients will have follow-up visits for up to 5 years to check on their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of follicular lymphoma (grades 1, 2, or 3A).
  • Must meet at least one of the following conditions to start treatment:
    • Involvement of 3 or more lymph nodes, each 3 cm or larger.
    • Any tumor 7 cm or larger.
    • Symptoms like unexplained fever, night sweats, or significant weight loss due to lymphoma.
    • Risk of symptoms affecting organs.
    • Enlarged spleen or specific spleen lesions.
    • Low blood cell counts or high lymphocyte counts.
    • Fluid buildup in the chest or abdomen due to lymphoma.
  • Must have measurable disease, such as a lymph node 1.5 cm or larger or a spleen longer than 13 cm.
  • Must be in good general health with an ECOG score of 0 to 2.
  • Must have adequate blood counts and organ function.
  • Must agree to use effective birth control during and after the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Have a different type of follicular lymphoma (grade 3B or transformed).
  • Are taking other experimental treatments.
  • Have lymphoma in the brain or spinal cord.
  • Have another cancer that could interfere with the study.
  • Have an active, uncontrolled infection.
  • Have serious health issues like recent heart attack, heart failure, or stroke.
  • Have used a monoclonal antibody in the last 4 weeks.
  • Are pregnant or breastfeeding.
  • Have active hepatitis B or C, unless under control.
  • Have HIV unless the viral load is undetectable and CD4 count is high enough.
  • Have certain rare genetic conditions affecting sugar absorption.
  • Have had major surgery recently, unless fully recovered.
  • Have had recent cancer treatment or live vaccines.
  • Have allergies to similar drugs used in the study.

Locations

FACILITYZIPCITYSTATE
Fred Hutch/University of Washington Cancer Consortium98109SeattleWashington

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