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:

• Children and young people aged 12 months to 21 years old at the time of joining the study.
• People whose cancer was confirmed by a tissue sample (biopsy) at first diagnosis or when the cancer came back — with exceptions for certain brain tumours where imaging or specific protein markers in the blood or spinal fluid are used instead.
• For Part A of the trial: People with solid tumours or lymphoma that have come back or stopped responding to treatment, including those with brain tumours or cancer that has spread to the brain.
• For Part B of the trial: People with a type of brainstem tumour called DIPG, or a related brain tumour called H3 K27-altered DMG, that has grown or come back after radiation treatment.
• For Part A: People whose cancer can be measured or tracked in some way on scans or tests.
• For Part B: People whose cancer can be measured on scans or tests.
• People whose cancer has no known curative treatment or treatment proven to extend life with a reasonable quality of life.
• People who are well enough to carry out some daily activities, based on standard performance scoring scales (a score of at least 50 out of 100 on the Karnofsky or Lansky scale, depending on age).
• People who have recovered from side effects of previous cancer treatments, and who have waited the required amount of time since their last treatment before joining (the waiting period varies depending on the type of treatment received — confirm specific timeframes with the trial site).
• People who have never previously received the study drug CBL0137.
• People with adequate blood cell counts — for those without cancer in the bone marrow, this means a neutrophil count of at least 1,000 per microlitre and a platelet count of at least 100,000 per microlitre without recent transfusions (confirm specific values with the trial site).
• People whose kidneys are working well enough, based on a blood or urine test (confirm acceptable levels with the trial site based on age and sex).
• People with solid tumours whose liver function blood tests are within acceptable ranges (confirm specific values with the trial site).
• People whose heart is pumping well enough, confirmed by a heart ultrasound or scan within 7 days before joining.
• People with a normal heart rhythm measurement (QTc less than 480 milliseconds) on a heart tracing test.
• People with a seizure disorder may be eligible if their seizures are well controlled without the use of certain anti-seizure medications (called enzyme-inducing anticonvulsants), and if there has been no increase in seizure frequency in the 7 days before joining.
• People whose nerve-related side effects from previous treatments are mild (grade 2 or lower), except for reduced tendon reflexes, which are allowed at any level.
• People who agree to have a central venous catheter (a small tube placed into a large vein) fitted before receiving the study drug, as this is required for administration.

Who may not be able to join:

• People who are pregnant or breastfeeding.
• Girls who have started their periods and are not willing to undergo a pregnancy test before joining.
• People of reproductive age who are not willing to use two effective forms of birth control (including a barrier method such as a condom) for the entire duration of the study.
• People currently taking steroid medications (corticosteroids) whose dose has not been stable or decreasing for at least 7 days before joining, or who have used steroids to manage immune-related side effects from prior treatment within the past 14 days.
• People currently taking part in another clinical trial involving an experimental drug.
• People currently receiving other cancer treatments (with a specific exception for leukaemia patients taking a drug called hydroxyurea, which may continue until 24 hours before starting this trial — confirm with trial site).
• People taking medications to prevent organ rejection after a bone marrow transplant, such as cyclosporine or tacrolimus.
• People taking certain medications that strongly affect how the body processes drugs, including some antibiotics, antidepressants, and other medicines (confirm specific drugs with the trial site), or who smoke, as this can affect how the study drug works.
• People taking medications known to cause a serious irregular heart rhythm called Torsades de Pointes — these must also be stopped at least 7 days before starting the study drug.
• People with a known condition affecting the blood vessels in their arms or legs (peripheral vascular disease).
• People with a history of blood clotting disorders.
• People with an infection that is not under control.
• People who have had a solid organ transplant (such as a kidney or liver transplant) in the past.
• People who, in the trial doctor's opinion, may not be able to follow the safety monitoring requirements of the study.

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