RECRUITING

Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma

Conditions

Ann Arbor Stage II Follicular Lymphoma Ann Arbor Stage II Marginal Zone Lymphoma Ann Arbor Stage III Follicular Lymphoma Ann Arbor Stage III Marginal Zone Lymphoma Ann Arbor Stage IV Follicular Lymphoma Ann Arbor Stage IV Marginal Zone Lymphoma Grade 1 Follicular Lymphoma Grade 2 Follicular Lymphoma Grade 3a Follicular Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Low Dose Mosunetuzumab for Indolent B-Cell Lymphoma

Quick Facts

Study Start:2024-08-29

Study Completion:2027-02-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06442475

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 equation * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), except in patients with Gilbert's syndrome who may have a total bilirubin up to ≤ 3 x ULN * Aspartate aminotransferase (AST) ≤ 3 x the ULN * Alanine aminotransferase (ALT) ≤ 3 x the ULN * Gamma glutamyl transferase (GGT) ≤ 3 x the ULN * Negative serum or urine pregnancy test within 7 days of initiating mosunetuzumab for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year * Fertile male and woman of childbearing potential must agree to use highly effective contraceptive methods from start of treatment to at least 3 months after the last dose of mosunetuzumab	* History of severe allergic reaction to monoclonal antibody therapy * History of a second primary malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. Malignancies treated curatively or at low-risk of progressing at the judgment of the principal investigator (PI) may be included * Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection at study enrollment * Infection with human immunodeficiency virus (unless viral load is undetectable and CD4 count ≥ 200) * Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HbBsAg\] serology): * Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated by institutional standards * Autoimmune disease requiring active therapy * History of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS) * Evidence of significant concurrent disease or medical condition that could interfere with the conduct of the study, or put the patient at significant risk including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm) * Ongoing systemic corticosteroid treatment, with the exception of corticosteroid use for other (non-tumor and non-immunosuppressive) indications up to a maximum of 10 mg/day of prednisone or equivalent * Prior use of any monoclonal antibody within 4 weeks before the first mosunetuzumab administration * Prior solid organ transplantation * Pregnant or breast-feeding women, or intending to become pregnant during the study or within 3 months of the last dose of mosunetuzumab

Inclusion Criteria

Exclusion 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 equation
* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), except in patients with Gilbert's syndrome who may have a total bilirubin up to ≤ 3 x ULN
* Aspartate aminotransferase (AST) ≤ 3 x the ULN
* Alanine aminotransferase (ALT) ≤ 3 x the ULN
* Gamma glutamyl transferase (GGT) ≤ 3 x the ULN
* Negative serum or urine pregnancy test within 7 days of initiating mosunetuzumab for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year
* Fertile male and woman of childbearing potential must agree to use highly effective contraceptive methods from start of treatment to at least 3 months after the last dose of mosunetuzumab

* History of severe allergic reaction to monoclonal antibody therapy
* History of a second primary malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. Malignancies treated curatively or at low-risk of progressing at the judgment of the principal investigator (PI) may be included
* Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection at study enrollment
* Infection with human immunodeficiency virus (unless viral load is undetectable and CD4 count ≥ 200)
* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HbBsAg\] serology):
* Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated by institutional standards
* Autoimmune disease requiring active therapy
* History of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
* Evidence of significant concurrent disease or medical condition that could interfere with the conduct of the study, or put the patient at significant risk including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
* Ongoing systemic corticosteroid treatment, with the exception of corticosteroid use for other (non-tumor and non-immunosuppressive) indications up to a maximum of 10 mg/day of prednisone or equivalent
* Prior use of any monoclonal antibody within 4 weeks before the first mosunetuzumab administration
* Prior solid organ transplantation
* Pregnant or breast-feeding women, or intending to become pregnant during the study or within 3 months of the last dose of mosunetuzumab

Contacts and Locations

Study Contact

Ajay Gopal

CONTACT

206-606-2037

agopal@uw.edu

Principal Investigator

Ajay Gopal

PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Study Locations (Sites)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: University of Washington

Ajay Gopal, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-29

Study Completion Date2027-02-12

Study Record Updates

Study Start Date2024-08-29

Study Completion Date2027-02-12

Terms related to this study

Additional Relevant MeSH Terms

Ann Arbor Stage II Follicular Lymphoma
Ann Arbor Stage II Marginal Zone Lymphoma
Ann Arbor Stage III Follicular Lymphoma
Ann Arbor Stage III Marginal Zone Lymphoma
Ann Arbor Stage IV Follicular Lymphoma
Ann Arbor Stage IV Marginal Zone Lymphoma
Grade 1 Follicular Lymphoma
Grade 2 Follicular Lymphoma
Grade 3a Follicular Lymphoma