Phase 2 Lymphoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older
• People with a general health and activity level rated as reasonably functional (scored 0 to 2 on a standard oncology scale called ECOG)
• People with blood counts and organ function (such as liver and kidneys) within acceptable levels
• Women who could become pregnant must have a negative pregnancy blood test and agree to use highly effective birth control; men must agree to use effective birth control during the trial
• People who are willing and able to give written consent to participate voluntarily

Cohort 1 — Previously Untreated, High-Risk Follicular Lymphoma:

• People diagnosed with a specific type of slow-growing lymphoma called follicular lymphoma (Grade 1–3a), confirmed by tissue biopsy, that tests positive for a protein called CD20, with no sign that the cancer has changed into a more aggressive form
• The lymphoma has spread to multiple areas of the body (Stage III or IV)
• No prior systemic (whole-body) treatment for follicular lymphoma
• Meeting at least one standard medical guideline that indicates treatment is needed (called GELF criteria)
• Classified as high-risk based on a standard scoring system (FLIPI-1 or FLIPI-2 score of 3 to 5)

Cohort 2 — Previously Untreated, Low-Tumor-Burden Follicular Lymphoma:

• People diagnosed with follicular lymphoma (Grade 1–3a), CD20-positive, Stage III or IV, confirmed by biopsy, with no prior systemic treatment
• No significant symptoms such as night sweats, fever, or weight loss, and no severe itching
• The amount of lymphoma in the body is considered low, and standard medical guidelines do not currently indicate treatment is needed
• At least one area of lymphoma that is large enough to be measured on a scan (longest measurement greater than 1.5 cm)
• People who are experiencing symptoms from the disease or who prefer active treatment over a monitoring-only approach

Cohort 3 — Relapsed or Returned/Treatment-Resistant Follicular Lymphoma:

• People diagnosed with follicular lymphoma (Grade 1–3a), CD20-positive, Stage III or IV, confirmed by biopsy, with no sign the cancer has transformed into a more aggressive type
• The lymphoma has come back or stopped responding to treatment, after having received at least one prior treatment course that included an anti-CD20 antibody medication
• No prior treatment with a CD20/CD3 bispecific antibody or a type of drug called an EZH2 inhibitor
• At least one area of lymphoma that can be detected and measured or assessed at the time of relapse

Who may not be able to join:

• People whose lymphoma has spread to the brain or spinal cord, or who have a specific type called primary mediastinal lymphoma, or whose cancer has transformed into a more aggressive form
• People with serious uncontrolled conditions affecting the heart, blood vessels, brain, blood clotting, connective tissue, or active severe infections
• People who are pregnant or currently breastfeeding
• People with a known history of HIV, or an active hepatitis C infection confirmed by a specific blood test
• People who currently have another cancer, have a history of another cancer, or who have received cancer treatment (including major surgery) within the past 4 weeks
• People with a known allergic reaction to the medications being studied in this trial
• People who must take certain medications that strongly interact with a liver enzyme called CYP3A4 (either blocking or speeding it up), if those medications cannot be stopped or switched
• People with other medical conditions, mental health conditions, or abnormal test results that the trial doctor believes could make participation unsafe or affect the trial results (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.