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:

• Adults aged 18 or older.
• People whose cancer has been confirmed by tissue testing as Mantle Cell Lymphoma (MCL) or Marginal Zone Lymphoma (MZL), including certain subtypes such as MALT lymphoma, SMZL, and NMZL.
• People with gastric MALT lymphoma who have already tried H. Pylori eradication treatment and are either not eligible for, have declined, or have already tried radiation therapy to the stomach.
• People who have received at least two previous rounds of systemic cancer treatment, and for whom no FDA-approved treatments are available or who have declined those options.
• People who have previously had an autologous stem cell transplant, as long as that treatment finished at least 3 months before starting this trial.
• People who have previously had CAR-T cell therapy, as long as that treatment finished at least 1 month before starting this trial.
• People whose condition is considered to need systemic treatment.
• People who have at least one measurable area of disease visible on a CT scan (at least 1.5 cm in size, or assessable in the opinion of the doctor running the trial).
• People whose life expectancy is considered to be more than 3 months, in the opinion of the treating doctor.
• People whose blood counts meet minimum levels set by the trial (confirm with trial site for specific numbers), including adequate levels of neutrophils, platelets, and haemoglobin — with some flexibility if the bone marrow or spleen is affected by the disease.
• People whose liver function tests are within acceptable ranges set by the trial, with some flexibility if the liver is affected by the disease.
• People whose kidney function meets the minimum level required by the trial (confirm with trial site for specific details).
• Women who are post-menopausal, or who have had a negative pregnancy test — with specific criteria depending on age and medical history (confirm with trial site for details).
• Women who are able to become pregnant, and men whose partners are able to become pregnant, where a highly effective form of contraception is agreed to be used throughout the trial.
• People who are able to swallow tablets by mouth.
• People who have recovered from side effects of previous treatments to an acceptable level, or whose remaining side effects are stable and not considered clinically significant by the treating doctor.
• People (or their legal representatives) who are able to read, understand, and agree to participate by signing an informed consent form.

Who may not be able to join:

• People who have previously been treated with an FGFR inhibitor medication.
• People with a significant condition affecting how the gut absorbs medications, which could interfere with the study drug being properly absorbed.
• People who are currently receiving other anti-cancer treatments (with limited exceptions for certain prostate or breast cancer treatments — confirm with trial site).
• People who have received certain prior cancer treatments too recently before joining the trial — including chemotherapy within 4 weeks, a monoclonal antibody within 3 weeks, or a BTK inhibitor within 2 weeks.
• People who have had radiotherapy within 4 weeks before the first dose (or 2 weeks for certain palliative radiation), or who have not fully recovered from radiation side effects.
• People who have had major surgery within 4 weeks before starting the trial, or who have not fully recovered from major surgery.
• People with another active cancer that, in the doctor's opinion, is expected to interfere with participation in the trial.
• People with known cancer involvement in the brain or spinal cord (central nervous system).
• People with serious heart conditions, including severe heart failure, unstable chest pain or a heart attack within the past 2–3 months, certain irregular heart rhythms, a specific abnormal heart rhythm reading on an ECG (QTcF above 470 ms), or a weakened heart pump (ejection fraction below 40% in the past 12 months) — with some specific exceptions that the trial site can confirm.
• People with any other condition that, in the doctor's judgment, makes participation unsafe or not feasible.
• People with a known HIV infection.
• People with active Hepatitis B or active Hepatitis C infection — though people with resolved Hepatitis B, or Hepatitis C where the virus is no longer detectable in the blood, may still be considered (confirm with trial site); people with SMZL and chronic Hepatitis C must have completed antiviral treatment to be considered.
• People with a history of abnormal calcium or mineral deposits in soft tissues or organs such as the kidneys, heart, lungs, or intestines (calcified lymph nodes or symptom-free calcification in arteries or cartilage are generally not excluded — confirm with trial site).
• People with a clinically significant eye condition affecting the cornea or retina, as confirmed by an eye examination.
• People who have taken certain medications that strongly affect how the body processes the study drug (specific CYP3A4 inhibitors or inducers) within 14 days or 5 half-lives before starting, whichever is longer.
• People with a history of severe vitamin D deficiency that required very high-dose vitamin D supplements to correct (standard dietary vitamin D supplements are generally permitted — confirm with trial site).
• People with medical, psychiatric, or cognitive conditions that could affect their ability to understand the trial, give consent, or follow the trial procedures.
• People with a known severe allergic reaction to the study drug or any of its ingredients.
• People taking certain other prohibited medications without completing an appropriate washout period beforehand.

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