Study on Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma
Sponsor: Washington University School of Medicine
ClinicalTrials ID:NCT05410418
This clinical trial is exploring a new treatment combination of mosunetuzumab and polatuzumab vedotin to see how well it works in patients with untreated follicular lymphoma. Mosunetuzumab helps the immune system target and kill cancer cells, while polatuzumab vedotin delivers a drug directly to cancer cells.
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Program Overview
The purpose of this study is to test a new treatment for follicular lymphoma, a type of blood cancer. The treatment combines two drugs: mosunetuzumab, which helps the immune system's T cells find and destroy cancer cells, and polatuzumab vedotin, which delivers a cancer-killing drug directly to the cancer cells. This study aims to see how effective this combination is in patients who have not yet received treatment for their follicular lymphoma.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with follicular lymphoma grades 1-3A, stages II-IV.
- Must meet at least one of the following conditions:
- Tumor mass larger than 7 cm.
- At least 3 lymph nodes larger than 3 cm each.
- Experiencing systemic or B symptoms (like fever, weight loss, night sweats).
- Enlarged spleen extending below the belly button.
- Compression symptoms affecting organs.
- Fluid buildup in chest or abdomen.
- Low blood cell counts due to lymphoma.
- Must be 18 years or older.
- Good general health with an ECOG performance status of 0 to 2.
- Adequate blood and organ function, unless affected by lymphoma.
- Women and men must agree to use effective birth control during the study and for a period after the last dose of the study drugs.
- Must be able to understand and sign a consent form.
Exclusion Criteria
- Previous aggressive B cell lymphoma like diffuse large B cell lymphoma.
- History of severe immune reactions to previous treatments.
- History of certain immune system disorders.
- Current or past brain lymphoma.
- Previous treatment for follicular lymphoma.
- Recent radiation therapy or treatment with certain antibodies.
- Recent serious brain or nervous system conditions.
- Use of strong immune-suppressing medications recently.
- History of organ or stem cell transplants.
- Previous CAR T cell therapy.
- Severe allergic reactions to similar drugs.
- Active infections or recent major infections.
- Active hepatitis B or C infections.
- HIV positive status.
- Recent live vaccine administration.
- Other cancers that could interfere with the study.
- Active autoimmune diseases requiring treatment.
- Significant heart or lung diseases.
- Recent major surgery.
- Pregnant or breastfeeding women, or those planning to become pregnant during the study.
- Any other serious medical conditions that could affect participation.
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