Phase 1 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:

• You are 18 years old or older
• You are able to understand and agree to participate by signing a consent form
• You are able to attend scheduled visits and follow the study's requirements
• You have been diagnosed with cutaneous T-cell lymphoma (a type of skin cancer affecting immune cells), confirmed by biopsy, that has come back or stopped responding to treatment, and you have already tried at least one systemic (whole-body) treatment
• You have a form of cutaneous T-cell lymphoma that has transformed into a more aggressive type (large cell transformation)
• You have adult T-cell leukemia/lymphoma (ATLL) of any stage or subtype, have had at least one standard chemotherapy treatment, and still have measurable disease
• Your cancer came back after a stem cell transplant (using your own or a donor's cells)
• Any previous cancer treatments (including radiation, chemotherapy, or topical steroids) were stopped at least 1 week before joining the study, with some specific exceptions for long-term steroid use (confirm with trial site)
• You are generally well enough to carry out daily activities with little to no limitation (confirm with trial site for exact fitness level required)
• Your blood counts and organ function (including white blood cells, platelets, liver, and kidneys) meet specific healthy levels as measured by blood tests (confirm with trial site for exact values)
• You have been free of other cancers for at least 2 years, with some exceptions such as certain treated skin cancers, early-stage prostate cancer being monitored without treatment, or certain treated B-cell lymphomas in remission (confirm with trial site)
• If you are a woman who could become pregnant, you have a negative pregnancy test at enrollment and agree to use highly effective birth control during the study; men whose partners could become pregnant must also agree to use effective birth control
• You are expected to live for at least 90 days

Who may not be able to join:

• You have received an experimental treatment within 2 weeks before starting the trial
• Your lymphoma has spread to your brain or spinal cord (central nervous system)
• You have HIV with a low immune cell count (CD4 below 350)
• You have had a solid organ transplant (such as a kidney, liver, or heart transplant)
• You have an active hepatitis B or hepatitis C infection (those with certain hepatitis B markers may still be eligible under specific conditions — confirm with trial site)
• You have a history of or currently have a rare brain condition called progressive multifocal leukoencephalopathy (PML)
• You have moderate to severe graft-versus-host disease (a complication that can occur after a donor stem cell transplant)
• You have a serious illness, medical condition, or organ problem that the study doctor believes could put you at risk
• You have significant heart disease that limits your daily physical activity (confirm with trial site for exact definition)
• You have a history of severe allergic reactions to humanized monoclonal antibody medications (a specific type of biological drug)
• You have another cancer history that could interfere with the study, with some exceptions for certain treated skin cancers, early-stage monitored prostate cancer, or cervical carcinoma in situ
• You are known to be allergic to any of the drugs used in this study
• You have an active serious infection, or were hospitalized for an infection or received IV antibiotics within 4 weeks before starting the study
• You have a significant history of liver disease, including hepatitis or cirrhosis
• You received a live-virus vaccine within 28 days before starting the study, or would need one during the study
• You had major surgery within 6 weeks before starting the study (unless it was done just for diagnosis)
• You are currently taking medications that suppress your immune system
• You have previously received a drug called mogamulizumab and stopped it because it stopped working or caused serious side effects
• You are pregnant, breastfeeding, or planning to become pregnant during the study

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