Study on Tazemetostat with Rituximab and Bendamustine for Initial Treatment of High Tumor Burden Follicular Lymphoma
Sponsor: Vaishalee Kenkre
ClinicalTrials ID:NCT05551936
This clinical trial is testing a new combination of drugs, including tazemetostat, rituximab, and bendamustine, to treat patients with high tumor burden follicular lymphoma. The study aims to determine the safety and effectiveness of this treatment approach.
Patient Parameters
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Program Overview
This study involves a treatment plan using tazemetostat, rituximab, and bendamustine for patients with high tumor burden follicular lymphoma. Patients will receive tazemetostat twice daily along with bendamustine and rituximab in a 28-day cycle for up to three cycles. Afterward, they will continue with tazemetostat and rituximab for another three cycles. The study is designed to evaluate the safety and effectiveness of this combination therapy.
Eligibility Criteria
Inclusion Criteria
- Must provide written consent and authorization for the release of personal health information.
- Must be 18 years or older.
- Must have a performance status score of 0-2, indicating full activity or some restriction in strenuous activities.
- Must have low-grade follicular lymphoma (grade 1-2 or 3A) without evidence of transformed lymphoma.
- Must have stage II, III, or IV lymphoma.
- Must meet criteria for high tumor burden follicular lymphoma or be high risk according to specific guidelines.
- Must have at least one tumor site that can be measured by scans.
- Must not have received prior therapy except for limited radiation, single-agent rituximab, or steroids for symptom control.
- Must have prior EZH2 testing or be willing to provide tissue for testing.
- Must have adequate organ function based on specific blood tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
- Men must agree to use effective contraception during and after the study.
- Must be able to understand and comply with study procedures.
Exclusion Criteria
- Active infection requiring treatment within 4 weeks of starting the study.
- Pregnant or breastfeeding women.
- Have another cancer within the last 3 years, except for certain non-threatening cancers.
- Have active cancer spread to the brain or spinal fluid.
- Have taken any investigational drug within 4 weeks before starting the study.
- Require chronic use of certain medications that affect drug metabolism.
- Have significant infections requiring treatment.
- Have uncontrolled HIV infection.
- Have hepatitis C infection unless specific tests are negative.
- Must be tested for hepatitis B and meet specific criteria to participate.
- Have significant heart disease or recent heart attack or chest pain.
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