RECRUITING

Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma

Conditions

Follicular Lymphoma Mosunetuzumab Tazemetostat

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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

The goal of this study is to learn about the safety and effectiveness of the combination of tazemetostat pills in combination with mosunetuzumab injections for people with follicular lymphoma who haven't received treatment before. The investigators hypothesize that tazemetostat with mosunetuzumab has the potential to increase the efficacy of the product without compromising the safety. Tazemetostat is a drug that inhibits EZH2, an enzyme known to drive the development of B-cell lymphomas, and inhibiting it appears to have many effects that slow down lymphoma growth and enhance the immune system's ability to fight it. Tazemetostat is FDA-approved in previously treated follicular lymphoma and currently undergoing study in other lymphomas. Mosunetuzumab is a bispecific antibody therapy that is a therapeutic strategy that uses the immune system to fight lymphoma, called immunotherapy. Bispecific antibodies have two ends: one attaches to T cells in the immune system and the other attaches to lymphoma cells, helping guide our immune system to attack the cancer. Mosunetuzumab has been studied in follicular lymphoma that has previously been treated, with positive results. Mosunetuzumab is approved by the FDA to be given intravenously (directly into a vein) but is not yet approved by the FDA is not yet approved as an injection under the skin, which is how it is given in this study. They have not yet been studied in combination.

Official Title

A Phase II Trial of Tazemetostat Plus Mosunetuzumab in Untreated Follicular Lymphoma

Quick Facts

Study Start:2023-11-01

Study Completion:2033-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05994235

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
* Ability to comply with the study protocol * Willing to use highly effective contraception, if of childbearing potential * Diagnosed with follicular lymphoma (FL; Grades 1-3a) * Received no prior systemic lymphoma therapy (local radiotherapy is not considered systemic therapy)	* Inability to take oral medication OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, vomiting) that might impair the bioavailability of tazemetostat * Grade 3b FL * History of transformation of indolent disease to diffuse large B cell lymphoma * Any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or myeloproliferative neoplasm (MPN) * Any prior history of T cell lymphoblastic lymphoma (T-LBL)/ T cell lymphoblastic leukemia (T-ALL) * Active or history of central nervous system lymphoma or leptomeningeal infiltration * Prior standard or investigational systemic anti cancer therapy for lymphoma. Patients who have received prior XRT will not be excluded * History of solid organ transplantation * History of severe allergic or anaphylactic reaction to humanized, chimeric or murine monoclonal antibodies (MAbs) * Known or suspected chronic active Epstein-Barr virus (EBV) infection * Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) * Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis * Active Hepatitis B or Hepatitis C infection * HIV positive with CD4 count \<200 and not currently taking antiretroviral therapy * History of progressive multifocal leukoencephalopathy (PML) * Active autoimmune disease requiring treatment * History of autoimmune disease, including, but not limited to: myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis * Prior allogeneic stem cell transplant (SCT) * Significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm) * Major surgery other than for diagnosis within 28 days prior to Day 1 of Cycle 1 Day 1 or anticipation of a major surgical procedure during the course of the study * Active central nervous system disease or underlying neurologic disease such as stroke or intracranial hemorrhage within 3 months prior to enrollment, history of seizure disorder, or history of neurogenerative disease * History of pneumonitis or interstitial lung disease * Pregnant or breastfeeding or intending to become pregnant during the study

Inclusion Criteria

Exclusion Criteria

* Ability to comply with the study protocol
* Willing to use highly effective contraception, if of childbearing potential
* Diagnosed with follicular lymphoma (FL; Grades 1-3a)
* Received no prior systemic lymphoma therapy (local radiotherapy is not considered systemic therapy)

* Inability to take oral medication OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, vomiting) that might impair the bioavailability of tazemetostat
* Grade 3b FL
* History of transformation of indolent disease to diffuse large B cell lymphoma
* Any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or myeloproliferative neoplasm (MPN)
* Any prior history of T cell lymphoblastic lymphoma (T-LBL)/ T cell lymphoblastic leukemia (T-ALL)
* Active or history of central nervous system lymphoma or leptomeningeal infiltration
* Prior standard or investigational systemic anti cancer therapy for lymphoma. Patients who have received prior XRT will not be excluded
* History of solid organ transplantation
* History of severe allergic or anaphylactic reaction to humanized, chimeric or murine monoclonal antibodies (MAbs)
* Known or suspected chronic active Epstein-Barr virus (EBV) infection
* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
* Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
* Active Hepatitis B or Hepatitis C infection
* HIV positive with CD4 count \<200 and not currently taking antiretroviral therapy
* History of progressive multifocal leukoencephalopathy (PML)
* Active autoimmune disease requiring treatment
* History of autoimmune disease, including, but not limited to: myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
* Prior allogeneic stem cell transplant (SCT)
* Significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
* Major surgery other than for diagnosis within 28 days prior to Day 1 of Cycle 1 Day 1 or anticipation of a major surgical procedure during the course of the study
* Active central nervous system disease or underlying neurologic disease such as stroke or intracranial hemorrhage within 3 months prior to enrollment, history of seizure disorder, or history of neurogenerative disease
* History of pneumonitis or interstitial lung disease
* Pregnant or breastfeeding or intending to become pregnant during the study

Contacts and Locations

Study Contact

Tejasvi Kaur Sahni

CONTACT

646-962-9337

tks4001@med.cornell.edu

Brittany Hobbie

CONTACT

brh4008@med.cornell.edu

Principal Investigator

Samuel Yamshon, M.D.

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine/NewYork-Presbyterian Hospital

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

Samuel Yamshon, M.D., PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

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 Date2023-11-01

Study Completion Date2033-10

Study Record Updates

Study Start Date2023-11-01

Study Completion Date2033-10

Terms related to this study

Keywords Provided by Researchers

Mosunetuzumab
Follicular Lymphoma
Tazemetostat

Additional Relevant MeSH Terms

Follicular Lymphoma