Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma (NCT06442475) | Clinical Trial Compass
RecruitingPhase 2
Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma
United States20 participantsStarted 2024-08-29
Plain-language summary
This phase II trial tests the safety, side effects and effectiveness of mosunetuzumab in treating patients with slow growing (indolent) B-cell lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 18 years or older at time of signing informed consent
* Capable of understanding and providing written informed consent
* Histologically confirmed indolent B-cell non-Hodgkin lymphoma with no prior therapy for lymphoma. (Prior peptide-based therapeutic vaccines are allowed.) Eligible histologies include:
* Follicular lymphoma (grade 1-2 or 3A)
* Marginal zone lymphoma
* Ann Arbor stage II-IV disease
* No prior therapy for lymphoma
* Have low-tumor burden disease, defined by Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria:
* Nodal or extranodal tumor mass \< 7 cm
* Involvement of less than 3 nodal sites with a diameter \> 3 cm
* No systemic or B symptoms
* No splenomegaly \> 16 cm by imaging
* No local risk of vital organ compression
* No pleural or peritoneal serous effusions
* No leukemic phase (\> 5,0000/ uL circulating lymphocytes)
* No significant cytopenias defined as platelets \< 100,000/uL, hemoglobin \< 10 g/dL, or absolute neutrophil count (ANC) \< 1500/ uL
* Have measurable nodal disease, including at least 1 disease site measuring at least 1.5 cm in longest dimension on CT or fludeoxyglucose F-18 (FDG)-PET, or a FDG-avid extranodal measurable site measuring at least 1.0 cm in longest dimension. Measurable disease also includes spleen size more than 13 cm in vertical length
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Creatinine clearance ≥ 50 mL/min calculated by Cockcroft-Gault equa…