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 given their written consent to participate (or whose legal representative has done so on their behalf)
• People who agree to allow stored tumor tissue from their biopsy to be used for the study (exceptions may be possible with approval from the lead study doctor)
• People who are 18 years of age or older
• People who have been newly diagnosed with classical Hodgkin lymphoma (a specific type confirmed by a specialist tissue examination), and have not had the nodular lymphocyte predominant subtype
• People who have not previously received systemic treatment for classical Hodgkin lymphoma — although a short course of steroid tablets to relieve symptoms is allowed, as long as it is stopped by the first day of treatment
• People who meet at least one of the following characteristics that makes standard chemotherapy (anthracycline-based) unsuitable: aged 75 or older; having a moderate-to-severe reduction in general physical functioning; reduced heart pumping function; reduced kidney function; or reduced lung function (confirm with trial site for specific measurements)
• People whose cancer can be measured on a scan — specifically, at least one affected area outside of bone that is 1.5 cm or larger
• People whose blood cell counts, liver function, and kidney function fall within the ranges required by the study (the trial site will check these through blood tests)
• People whose blood clotting levels are within acceptable ranges, whether or not they are taking blood thinners
• People who test negative for active hepatitis B and hepatitis C infections, or who have a past infection with undetectable virus levels and agree to regular virus monitoring if required
• Women who are not pregnant and not breastfeeding, and who either cannot become pregnant or agree to use reliable contraception during treatment and for a specified period afterwards
• Men who agree to use contraception during treatment and for at least 6 months after the last dose, and who agree not to donate sperm during that time

For people moving on to a second phase of treatment (called salvage treatment), additional requirements apply:

• General physical functioning must still be at an acceptable level
• Side effects from earlier treatment must have settled back to baseline or a mild level
• Cancer must still be measurable on a scan
• Any nerve-related side effects (such as tingling or numbness) must be mild or absent
• Blood counts, liver function, and kidney function must still meet the required levels (confirm specific values with trial site)

Who may not be able to join:

• People currently taking part in another experimental treatment study
• People who have received a live vaccine (such as measles, mumps, chickenpox, or yellow fever) within 30 days before starting treatment
• People who already have moderate or severe nerve damage (such as numbness or tingling in the hands or feet) before starting the trial
• People who require dialysis for kidney failure
• People whose lymphoma has spread to the brain or the lining around the brain
• People who have previously had a severe allergic reaction (grade 3 or higher) to either of the main study drugs
• People with an active, uncontrolled infection that is not improving despite treatment
• People who have had another cancer diagnosis within the past 3 years — with some exceptions, such as certain skin cancers, cervical changes caught early, or cancers not expected to need treatment for at least 2 years (confirm with trial site)
• People who need ongoing high-dose steroid or other immune-suppressing medications, with some exceptions such as inhaled or skin-applied steroids, or low-dose steroids for a hormone condition
• People with a history of a rare and serious brain condition called progressive multifocal leukoencephalopathy (PML)
• People with active lung inflammation (pneumonitis) or scarring lung disease
• People who have previously had an organ transplant or a stem cell transplant from a donor
• People with a history of a rare immune condition called hemophagocytic lymphohistiocytosis (HLH)
• People with an active autoimmune disease — with some exceptions, including vitiligo, well-controlled thyroid disease, well-controlled type 1 diabetes, and psoriasis not requiring systemic treatment
• People with an active hepatitis B or hepatitis C infection (past infections with undetectable virus may be acceptable — confirm with trial site)
• People who are HIV positive
• People who have had a stroke, mini-stroke, unstable chest pain, heart attack, or serious heart symptoms within the 6 months before starting treatment
• People with any other health condition that the study doctor believes would make participation unsafe
• People who, in the study doctor's opinion, may not be able to follow the study procedures reliably

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