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 who have been diagnosed with Mantle Cell Lymphoma (MCL), confirmed by a tissue biopsy, according to the 2017 WHO classification
• People aged 18 to 84 years old
• People whose MCL has come back or stopped responding to one, two, three, or four previous rounds of treatment
• People who have either never received a chemotherapy drug called bendamustine, or whose last bendamustine-containing treatment ended at least one year ago
• People who have previously been treated with a type of targeted therapy called a BTK inhibitor (either alone or combined with other treatments), whether the disease came back afterward or the treatment had to be stopped due to side effects while the disease was still active
• People who have previously received treatments that target a protein called CD19 (including CAR-T cell therapy) — though in this case, testing of CD19 levels in tissue will be required
• People who have previously been treated with a drug called venetoclax
• People who may be eligible for a stem cell transplant
• People who have measurable disease (a lymph node or other affected area at least 1.5 cm in size, measurable in two directions) — or people whose lymphoma is only found in the bone marrow (with mandatory bone marrow biopsy required)
• People with a general health/activity level rated at 0, 1, or 2 on the ECOG scale (a standard measure of how much a person's illness limits daily activities), unless any limitations are caused by the MCL itself
• People whose blood test results at the screening stage meet specific levels for white blood cells, platelets, kidney function, and liver function (confirm with trial site for exact values)
• People who are willing and able to sign an informed consent form before any study-related procedures begin
• People who are able to attend study visits and follow the study requirements
• People with a life expectancy of at least 3 months
• Women who could become pregnant, and men with partners who could become pregnant, who agree to use effective contraception during the study and for a set period after the last dose of the study drug (10 months for women, 7 months for men)

Who may not be able to join:

• People who received bendamustine as part of a previous treatment and whose disease came back less than one year after finishing that treatment
• People with a known history of serious allergic reactions to human antibody-based medicines
• People who received a donor (allogeneic) stem cell transplant within the 6 months before starting the study
• People who received a donor stem cell transplant and still have active or uncontrolled graft-versus-host disease
• People who have previously been treated with any therapy that targets the CD19 protein (confirm with trial site, as this appears to conflict with an inclusion criterion — direct clarification from the trial site is recommended)
• People who have had more than four previous lines of treatment (note: an autologous stem cell transplant done as consolidation after a treatment line does not count as a separate line)
• People who have had another active cancer in the past three years, with some exceptions such as certain skin cancers, non-spreading prostate cancer, cervical cancer in situ, or certain early-stage breast conditions (the trial team assesses this individually)
• People who have had major surgery or received any cancer treatment — including chemotherapy, immunotherapy, radiation, or experimental therapies — within 14 days before starting the study drug
• People with significant heart disease rated at class 2 or above on the NYHA scale (a standard measure of heart-related activity limitations)
• People with serious uncontrolled conditions affecting the nervous system, mental health, hormones, metabolism, immune system, or liver that would affect their ability to participate or to give informed consent
• People with uncontrolled or active infections (including viral infections such as COVID-19, bacterial, or fungal infections)
• People with active hepatitis B or C requiring treatment (some people with past hepatitis B exposure or certain inactive forms may still be eligible — confirm with trial site)
• People who test positive for HIV
• People whose lymphoma has spread to the brain or the lining around the brain and spinal cord at the time of screening
• People with a heart rhythm condition called long QT syndrome (either inherited or showing a specific abnormal reading on an ECG at screening), unless it is related to a pacemaker or a specific type of heart conduction issue
• People who, in the treating doctor's judgement, have any other medical condition that would make participation unsafe or inappropriate
• People who are pregnant or breastfeeding

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