Study on Mosunetuzumab for People with Follicular Lymphoma
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT05389293
This clinical trial is exploring whether the drug mosunetuzumab is effective for treating people who have recently been diagnosed with follicular lymphoma and have not yet received any treatment.
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Program Overview
The aim of this study is to determine if mosunetuzumab can effectively treat follicular lymphoma in patients who have been newly diagnosed and have not started any treatment. The study initially enrolled 53 participants and plans to include an additional 23 participants.
Description
This study is investigating the use of mosunetuzumab in treating follicular lymphoma, a type of blood cancer. Researchers are looking to see if this drug can help people who have been recently diagnosed and have not yet received any treatment. The study will initially include 53 participants and may expand to include 23 more. Participants will need to meet certain health criteria and agree to provide tumor samples for analysis. The study will involve regular health checks and monitoring to ensure the safety and effectiveness of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a confirmed diagnosis of follicular lymphoma, grades 1, 2, or 3A, that has not been treated.
- Must have stage II bulky, III, or IV disease.
- Must need systemic therapy based on specific health criteria, such as large tumors or certain symptoms like fever, night sweats, or weight loss.
- Must have at least one measurable tumor by scan.
- Must agree to provide tumor samples before and after starting treatment.
- Must have adequate liver and bone marrow function based on blood tests.
- Must have normal kidney function or a creatinine clearance of at least 45 mL/min.
- Women of childbearing potential must agree to use effective contraception during and after treatment.
- Men must agree to use condoms or remain abstinent during and after treatment.
Exclusion Criteria
- Cannot comply with study procedures.
- Have grade 3B or transformed follicular lymphoma.
- Do not meet criteria for systemic therapy.
- Are unfit for chemoimmunotherapy due to age or other health issues.
- Have follicular lymphoma in isolated areas like the duodenum or skin.
- Have had prior anti-lymphoma therapy or organ transplants.
- Have current or past central nervous system lymphoma or significant CNS disease.
- Have significant heart or lung disease.
- Have active infections or certain viral infections like hepatitis or HIV.
- Have received a live vaccine recently.
- Are pregnant, breastfeeding, or planning to become pregnant during the study.
- Have had recent major surgery.
- Have a history of autoimmune disease or severe allergic reactions to similar treatments.
- Have a history of other cancers, except for certain skin or cervical cancers.
- Are taking certain immunosuppressive medications.
- Have a history of drug or alcohol abuse within the past year.
- Have any serious medical condition that could affect participation in the study.
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