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 years or older, of any gender, who weigh less than 180 kg.
• People who have signed a consent form before any study activities begin (a legal guardian may sign if the patient is temporarily unable to do so due to their illness).
• People who have at least one measurable area of lymphoma in the central nervous system (brain or spinal cord area), visible on a scan.
• People who have been diagnosed with primary or secondary central nervous system lymphoma (lymphoma in the brain or spinal cord) that has come back or stopped responding to treatment, confirmed by lab or imaging tests at the time of first diagnosis.
• People whose lymphoma has returned (with new areas affected or after a period of full remission) or whose lymphoma did not respond to initial treatment, or got worse after only a partial response — there is no limit on the number of times the disease may have returned.
• People who have stored stem cells, with at least 2 million CD34+ cells per kilogram of body weight available.
• Women who could become pregnant must agree to use effective contraception throughout the study and for six months after the last dose.
• Women who cannot become pregnant must have documented evidence of this (such as a record of tubal ligation, hysterectomy, or being post-menopausal).
• Men whose partner could become pregnant must agree to use effective contraception throughout the study and for six months after treatment.
• People who are reasonably physically functional, as measured by a standard medical scale (ECOG score of 2 or below, meaning the person may have some symptoms but is able to care for themselves) (confirm with trial site).
• People whose tumour has been confirmed to carry a specific protein called CXCR4, detected by a specialised scan (a type of PET scan using a tracer called [68Ga]Ga-PentixaFor), done within two months before joining or during the screening period.
• People whose recent blood test results fall within the following ranges (confirm specific values with trial site): sufficient white blood cell counts, haemoglobin at or above 8 g/dL, adequate platelet levels, liver enzyme levels within acceptable limits, kidney function within acceptable limits, and bilirubin within acceptable limits.

Who may not be able to join:

• People with a known or suspected allergic reaction to the study treatment or related products.
• People who are unable to have a contrast-enhanced MRI scan (for example, due to a pacemaker, defibrillator, metal in the body, severe claustrophobia, or kidney problems) or who cannot receive the gadolinium dye used in MRI.
• People who have previously signed a consent form for this same study.
• Women who are pregnant, breastfeeding, planning to become pregnant, or who are of childbearing potential and not using adequate contraception — a pregnancy test will be done at the start of the study for women who could potentially become pregnant.
• Men of reproductive age, or whose partner could become pregnant, who are not using adequate contraception.
• People who have participated in another clinical trial within the past 30 days (or longer, depending on the previous study drug) before screening.
• People with certain other serious health conditions — such as active infection, unstable heart conditions, uncontrolled high blood pressure, or poorly controlled diabetes — that the study doctor believes could put them at risk or affect their ability to safely take part.
• People with an active serious infection, or who have had a serious infection in the six weeks before treatment; people with uncontrolled HIV, or active hepatitis B or C infection. (Note: people with HIV that is well controlled on medication may be considered eligible by the study doctor.)
• People with secondary central nervous system lymphoma that has also spread to other parts of the body outside the central nervous system.
• People who have been taking immunosuppressive medicines (such as steroids for autoimmune conditions or following an organ transplant) for more than 21 days continuously — those who have taken them for fewer than 21 days may still be considered.
• People who are unable to understand the nature or consequences of the study, or who are unwilling to cooperate, and who do not have a designated legal representative.
• People who have received radiation therapy to the brain within the 180 days before the study treatment infusion.

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