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 relapsed or refractory CLL (chronic lymphocytic leukaemia), or SLL (small lymphocytic lymphoma, in the phase II part of the trial only), meaning the disease has come back or stopped responding to treatment after at least one previous course of treatment
• People whose disease currently meets established medical guidelines indicating that treatment is needed
• People aged 18 or older
• People with a general health and activity level rated as reasonably functional (on a standard medical scale of 0–2, where 0 means fully active and 2 means able to care for oneself but unable to work)
• People who previously received venetoclax treatment, provided it ended at least 24 months before joining and the disease did not get worse while taking it
• People with adequate bone marrow function — meaning blood counts (red blood cells, white blood cells, and platelets) are above certain minimum levels, unless low counts are directly caused by the leukaemia affecting the bone marrow (confirmed by biopsy)
• People with kidneys functioning well enough, as measured by standard blood tests
• People with adequate liver function, as shown by specific liver enzyme and bilirubin blood test results within acceptable ranges
• People with blood clotting measurements within acceptable ranges, unless already on anticoagulant (blood-thinning) medication
• People who test negative for hepatitis B and hepatitis C viruses, or who test positive for certain hepatitis markers but have a negative PCR (virus detection) test within 6 weeks before joining
• People who are able and willing to attend all required study visits and follow the study requirements
• People who are able to understand the trial and give their written informed consent

Who may not be able to join:

• People who have received CLL/SLL treatment within the 14 days before joining
• People who have previously been treated with a CD3 × CD20 bispecific antibody or CAR T-cell therapy
• People whose CLL has transformed into a more aggressive type of lymphoma (known as Richter's transformation)
• People who have previously had an allogeneic stem cell transplant (donor stem cells) or a solid organ transplant
• People with a confirmed history of a serious brain condition called progressive multifocal leukoencephalopathy (PML)
• People who currently have another cancer that requires systemic (whole-body) treatment, was not treated with the aim of a cure, or has shown signs of returning after curative treatment
• People with a known allergy to a class of medicines called xanthine oxidase inhibitors, or to a medicine called rasburicase
• People who have had a serious allergic reaction, including anaphylaxis, to any of the study drugs or their ingredients
• People with active or uncontrolled serious bleeding, or a bleeding disorder such as haemophilia or severe von Willebrand disease
• People with an active infection of any kind (fungal, bacterial, or viral) that is more than very mild in severity
• People with serious uncontrolled medical conditions such as uncontrolled infection, immune-related blood disorders, diabetes, high blood pressure, or thyroid problems
• People who are known to be HIV-positive
• People who need treatment with certain strong medications that affect how the liver processes drugs (strong CYP3A inhibitors or inducers), or who need blood-thinning medications such as warfarin, phenprocoumon, or other vitamin K antagonists
• People with serious heart conditions, including unstable or severe heart failure, uncontrolled heart rhythm problems, a heart attack, stroke, or brain bleed within the past 6 months, or certain abnormal ECG (heart tracing) results
• People with severe lung problems
• People with severe neurological (brain or nervous system) or psychiatric (mental health) conditions
• People with more than mild nerve damage or neuropathy
• People who have significant difficulty swallowing tablets or capsules, or who have a gut condition that would prevent oral medication from being properly absorbed
• People who have received a live vaccine within the 28 days before joining
• People who have used another experimental drug or treatment within the 28 days before joining
• People who have had major surgery within the 28 days before joining
• Women who are pregnant or breastfeeding
• People who are able to have children and are not surgically sterile or at least 2 years past menopause, unless they are willing to use a highly effective form of contraception during the study treatment and for 12 months after the last dose of one study drug (epcoritamab) and 30 days after the last dose of another (venetoclax)
• People who previously participated in the HOVON 139 CLL or HOVON 140 CLL trials and who are eligible for and willing to join the HOVON 159 CLL trial instead
• People currently participating in another clinical trial involving a medicinal product
• People whose personal, family, social, or geographic circumstances may make it difficult to follow the study requirements and attend follow-up appointments

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