Phase 1 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 of any gender, race, or ethnic background
• People who are able to swallow and keep down oral (by mouth) medication
• People who have been diagnosed with CLL (chronic lymphocytic leukaemia) or SLL (small lymphocytic lymphoma) that has not yet been treated, confirmed by specific blood or tissue tests
• People whose blood has a detectable immune cell gene marker, identified through a specific laboratory test used to track very small amounts of disease
• People whose CLL/SLL meets at least one sign that treatment is needed, such as: worsening anaemia or low platelet counts; an enlarged spleen causing symptoms or growing significantly; significantly enlarged lymph nodes; rapidly increasing white blood cell counts; anaemia or low platelets caused by the immune system attacking itself and not responding well to standard treatment; or symptoms such as losing 10% or more of body weight unintentionally in 6 months, significant ongoing tiredness, unexplained fevers, or night sweats lasting more than a month
• People with SLL specifically who have at least one enlarged lymph node of a minimum size, visible on a CT or MRI scan
• People whose general physical functioning is rated at a level showing they are able to carry out basic daily activities (confirm with trial site)
• People whose treating doctor estimates they are expected to live longer than 12 months
• People whose blood test results for neutrophils (a type of white blood cell) and platelets are above certain minimum levels (confirm with trial site for exact values)
• People whose kidney function tests are within an acceptable range (confirm with trial site)
• People whose liver function tests — including AST, ALT, ALP, and bilirubin — are within acceptable ranges, or who have a documented condition called Gilbert's syndrome affecting bilirubin levels
• People who test negative for active hepatitis C and hepatitis B infections, with specific conditions for those who show signs of past exposure (confirm with trial site)
• People who have been vaccinated against hepatitis B and show immunity, or who have previously recovered from hepatitis B with no detectable virus
• People who are able to become pregnant who have had a negative pregnancy test within 7 days before starting treatment, and who agree to use approved contraception during the trial and for 6 months after the last dose of one of the study drugs (obinutuzumab)
• People who can father a child who agree to use approved contraception during the trial and for 6 months after the last dose of obinutuzumab, and who agree not to donate sperm during that period
• People who are breastfeeding or able to produce eggs who agree to stop breastfeeding and not donate eggs from the start of treatment and for 6 months after the last dose of obinutuzumab

Who may not be able to join:

• People who have been diagnosed with any other blood cancer, either previously or at the same time
• People who have previously received any treatment specifically targeting CLL (certain low-dose steroid use may be permitted — confirm with trial site)
• People who have a known allergy or serious reaction to certain types of antibody-based medicines, including the specific drugs used in this trial (tafasitamab or acalabrutinib)
• People who have received a live vaccine within 14 days before enrolling in the trial
• People who have had a previous solid tumour (non-blood cancer) within the past 2 years, with some exceptions for certain early-stage or skin cancers (confirm with trial site)
• People with a confirmed history of a serious brain condition caused by a viral infection called progressive multifocal leukoencephalopathy (PML)
• People with an active autoimmune disease requiring high-dose steroid treatment, except for certain immune-related blood conditions (confirm with trial site)
• People with an ongoing, active infection throughout the body caused by bacteria, fungi, or a virus (minor localised fungal skin or nail infections may be permitted)
• People who are HIV positive or have a history of active HIV infection
• People whose CLL has transformed into a more aggressive type of lymphoma (known as Richter's transformation)
• People with known bleeding disorders
• People currently taking certain blood-thinning medications (warfarin, marcumar, or phenprocoumon), unless those medications can be safely stopped and blood levels normalise within 7 days of starting the trial
• People who have recently taken certain medications known to strongly or moderately affect how the body processes drugs (confirm with trial site, as a waiting period or special approval may be required)
• People with significant or uncontrolled heart conditions, including severe heart failure, low heart pumping function, poorly controlled irregular heart rhythm, history of dangerous heart rhythm problems, a heart attack within the past 6 months, chest pain not well managed by medication, or significant blood vessel disease affecting the heart or brain within the past 6 months
• People with any other serious medical condition that, in the trial doctor's judgement, would make participation unsafe or unsuitable

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