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 to 75 who have not yet received treatment for a type of aggressive blood cancer called high-grade B cell lymphoma (HGBCL) or diffuse large B cell lymphoma (DLBCL), including cases where another lymphoma has transformed into DLBCL
• People whose cancer has a specific genetic change called a c-Myc rearrangement, confirmed by a specialised lab test called FISH — this includes single-hit, double-hit, or triple-hit lymphoma
• People whose cancer diagnosis has been reviewed and confirmed by specialist pathologists at the enrolling hospital or a central reviewing institution
• People with cancer at Stage II or higher, and an International Prognostic Index (IPI) score between 2 and 5 (a scoring system doctors use to assess disease risk)
• People who are able to follow the study schedule and procedures, as judged by the study doctor
• People who have at least one measurable area of cancer large enough to be tracked on scans (confirm with trial site for exact size requirements)
• People who have a stored or newly collected tumour tissue sample available before joining the study
• People with a general physical functioning score of 0, 1, or 2 on a standard medical scale (meaning able to carry out daily activities, with varying levels of limitation)
• People whose heart is pumping at a normal level, confirmed by a heart scan
• People with blood counts and kidney function meeting specific minimum levels, as tested before joining (confirm with trial site for exact values)
• People of childbearing potential who agree to use highly effective contraception or remain abstinent during treatment and for at least 3 months after the last dose of study medications, and who agree not to donate eggs during this period
• People who can produce sperm who agree to use a condom or remain abstinent during the study, and agree not to donate sperm

Who may not be able to join:

• People who are pregnant or breastfeeding/chestfeeding
• People who have previously received treatment for DLBCL, with some limited exceptions (such as certain prior treatments for follicular lymphoma more than 3 years ago, or limited pre-phase treatments such as short-course steroids, one cycle of certain chemotherapy regimens, single-agent rituximab, or radiation to up to 3 sites — confirm with trial site)
• People with a history of severe allergic or anaphylactic reactions to certain types of antibody-based medicines, or known sensitivity to mouse-derived products
• People who have a medical reason they cannot receive the full doses of the chemotherapy combination used in this trial (called EPOCH)
• People with a history of a serious brain condition called progressive multifocal leukoencephalopathy (PML)
• People with a known or suspected long-term active infection with Epstein-Barr virus (EBV)
• People with an active hepatitis B infection (with some exceptions for people with past exposure but no active virus — confirm with trial site)
• People with an active hepatitis C infection (people who test positive for past exposure but have no active virus detected may still be considered)
• People who are HIV positive
• People who have received a live vaccine within 4 weeks before starting the trial, or who are expected to need one during the trial
• People who have previously had a solid organ transplant (such as a kidney, liver, or heart transplant)
• People with a known or suspected history of a serious immune condition called hemophagocytic lymphohistiocytosis (HLH)
• People with a history of certain autoimmune diseases (where the immune system attacks the body), though some exceptions may apply — for example, people with stable thyroid-related autoimmune disease on steady medication, controlled Type 1 diabetes, or certain stable autoimmune blood conditions may still be considered after review by the lead study doctor
• People currently taking immune-suppressing medications (such as certain drugs used to prevent organ rejection or treat autoimmune conditions), with some limited exceptions such as inhaled steroids or low-dose steroids for specific medical reasons
• People whose lymphoma has spread to the brain or spinal cord (central nervous system)
• People with a current or past history of certain brain or nervous system conditions such as stroke, epilepsy, brain blood vessel inflammation, or degenerative brain disease — though some exceptions may apply for people with a stroke history or epilepsy history with no recent episodes (confirm with trial site)
• People who received radiation to the chest/heart area within the past 4 weeks, or other pre-phase chemotherapy or radiation within the past 3 weeks
• People with another cancer that has not been in complete remission without treatment for at least 2 years — though people with a history of certain skin cancers or early-stage cervical cancer may still be considered, and people on hormone therapy for early-stage breast cancer may also be considered
• People with serious uncontrolled other illnesses that could affect their safety or the study results, including significant kidney or lung disease
• People with significant lung disease, including chronic obstructive lung disease or a history of airway spasms
• People with significant heart problems, including severe heart failure, a heart attack in the past 6 months, unstable heart rhythm, or unstable chest pain
• People with an active infection at the time of enrolment, or who needed hospital treatment or intravenous antibiotics for an infection within 10 days before starting the trial
• People with a significant history of liver disease, including viral hepatitis, active alcohol misuse, or liver scarring (cirrhosis)
• People with liver enzyme levels or bilirubin (a liver marker) above certain thresholds on blood tests
• People with blood clotting test results above certain levels (unless already on blood-thinning treatment — confirm with trial site)
• People using herbal products intended to treat their lymphoma
• People using medicinal or recreational cannabis products while receiving the study treatment

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