Phase 2 Leukaemia 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 10 years or older
• For the Phase 1 part of the trial: People with a solid tumour that has come back or stopped responding to previous treatment, where testing has confirmed a specific genetic change called a FET fusion (involving genes called EWSR1, FUS, or TAF15), detected by one of several approved lab methods
• For the Phase 2 part of the trial: People with a bone cancer called Ewing sarcoma that has come back or stopped responding to previous treatment, where a specific genetic change called EWS-FLI1 has been confirmed by lab testing, and where tissue is available for further central testing
• People who are generally well enough to carry out daily activities (confirmed using standard medical scoring tools appropriate for age)
• People who have at least one area of disease that can be measured on a CT or MRI scan taken within 28 days before starting treatment (Phase 1 also allows for disease that hasn't been previously treated with radiation)
• People whose liver, kidney, bone marrow, muscle, and heart are functioning within acceptable ranges as defined by the trial (confirm specific values with trial site)
• People who are able and willing to give written consent to take part
• People who are able to use effective contraception from the time of screening until 7 months after the last dose (for females) or 4 months after the last dose (for males); females who could become pregnant must have a negative pregnancy test at screening
• People aged 18 and over who are willing to have a tumour biopsy at the start of the study; people with Ewing sarcoma or a tumour type called DSRCT must also be willing to have a biopsy after treatment (if biopsy is not safe, the lead researcher must approve enrolment and archived tissue must be available)
• People who have waited a required amount of time since their last treatment before joining — the waiting period depends on the type of treatment previously received (confirm specific timeframes with trial site)
• People who have recovered from the side effects of previous treatments to an acceptable level, with the exception of hair loss and reduced reflexes

Who may not be able to join:

• People who have previously been treated with the drugs trabectedin or lurbinectedin
• People who have cancer that has spread to the brain
• People with a known condition that causes problems with blood clotting or bleeding
• People who are pregnant or breastfeeding
• People currently receiving another experimental drug or any other cancer treatment
• People taking over-the-counter or herbal supplements that may cause significant liver harm, in the opinion of the treating doctor
• People who need to take certain medications that strongly affect how the body processes drugs (known as CYP3A4 inhibitors or inducers) within 14 days before the first dose (confirm specific medications with trial site)
• People with a significant unrelated illness or uncontrolled infection that, in the treating doctor's opinion, could affect their ability to safely take part in the trial
• People who, in the investigator's opinion, may not be able to follow the safety monitoring requirements of the study
• People with known active hepatitis A, B, or C infection
• People with a tumour type called Desmoplastic small round cell tumour (DSRCT) may not be able to join until certain early safety conditions have been met in the trial (confirm current status with trial site)

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