Phase 1 Leukaemia Trial, Recruiting

Written by an AI model from the 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 1 to 21 years old at the time of joining the study.
• People who have a blood cancer (such as certain types of leukemia, lymphoma, or related conditions) that has come back or stopped responding to treatment.
• People whose cancer cells show a specific protein on their surface called CD123, confirmed by laboratory testing.
• For the monotherapy part of the study (Part 1): people whose cancer has come back a second time or more, or whose cancer did not respond to two or more rounds of chemotherapy, or who relapsed once after cancer that never fully responded to chemotherapy — or people with a condition called BPDCN that has come back once or did not respond to at least one round of chemotherapy.
• For the combination therapy part (Part 2): people whose cancer has come back at least once, or did not respond to two or more rounds of chemotherapy, or people with BPDCN that has come back once or did not respond to at least one round of chemotherapy.
• For leukemia: people who have more than 5% leukemia cells in their bone marrow (or between 1–5% in certain specific circumstances under Part 2 only — confirm with trial site).
• For lymphoma: people whose cancer has been confirmed by tissue testing, is measurable on scans or in bone marrow, and meets specific criteria about where the cancer is located in the body.
• People whose general health and ability to function meets a minimum level on a standard medical scale (confirm with trial site).
• People who have recovered from the side effects of previous cancer treatments before joining.
• People who have had a bone marrow or stem cell transplant may be eligible, provided it has been at least 100 days since the transplant and there is no active graft-versus-host disease (a complication where donor cells attack the body).
• People who have received certain prior treatments must have waited specific time periods before joining (confirm specific waiting periods with trial site).
• People who have previously received other CD123-targeting treatments (other than tagraxofusp) may still be eligible.
• People whose kidneys, liver, heart, and lungs are functioning at adequate levels based on standard medical tests.
• People with a platelet count of at least 20,000/mm³ at the start of treatment (transfusions to reach this level are allowed).
• Female patients who are able to become pregnant must have a negative pregnancy test within 2 weeks before joining.
• People who are able to use an effective form of contraception during the study and for 12 weeks after the last dose of treatment.
• People with Down syndrome may be eligible for Part 1 only.

Who may not be able to join:

• People who have cancer that has spread only to the central nervous system (brain and spinal cord) — this excludes them from both parts of the study.
• People who have cancer in the central nervous system — this excludes them from Part 1 (though Part 2 may still be possible in some cases — confirm with trial site).
• People who have been taking steroid medications for disease control and have not been on a stable or decreasing dose for at least 7 days before joining.
• People who are currently taking another experimental drug not approved by a national medicines regulator (such as the FDA, Health Canada, or the TGA).
• People who are currently receiving or are expected to receive other cancer treatments, radiation, or immunotherapy while on the study (with some specific exceptions — confirm with trial site).
• People who are taking medications to prevent graft-versus-host disease or organ rejection (such as cyclosporine or tacrolimus), unless at least 4 weeks have passed since the last dose.
• People who have had a positive blood infection test within 48 hours of joining.
• People who have had a fever with signs of infection within 48 hours of joining (fever caused by the cancer itself may be acceptable under specific conditions — confirm with trial site).
• People who have had a positive fungal infection test within 30 days of joining.
• People who have an active infection requiring treatment through a drip (IV), whether bacterial, fungal, viral, or parasitic.
• People who have previously been treated with tagraxofusp (the specific drug used in this trial).
• People who have a known allergy to any of the drugs used in this study.
• People who have another serious illness, mental health condition, or personal situation that could affect their safety or ability to follow the study requirements.
• People with certain inherited conditions that affect DNA repair, such as Fanconi anemia or Bloom syndrome.
• Female patients who are breastfeeding.
• People whose kidney, liver, heart, or lung function does not meet the minimum levels required by the study.

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