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 who have been diagnosed with adult T-cell leukemia/lymphoma (ATL) confirmed by lab testing, and who also test positive for HTLV-1 antibodies, with an aggressive form of the disease
• People between the ages of 20 and 85
• People whose ATL has come back or stopped responding to treatment, and who have previously been treated with a drug called mogamulizumab
• People whose ATL has come back or stopped responding to treatment, and where the trial doctors have determined mogamulizumab is not a suitable option, with at least one prior chemotherapy treatment received
• People whose ATL has come back or stopped responding after a bone marrow/stem cell transplant from a donor
• People whose disease is detectable in the blood
• People with a general health and activity level rated 0–2 on a standard medical scale (meaning able to carry out daily activities, possibly with some limitations) (confirm with trial site)
• People whose liver function test results are within an acceptable range as determined by the trial (confirm with trial site)
• People with a life expectancy of more than 3 months

Who may not be able to join:

• People who weigh less than 35 kg
• People with low red blood cell levels (haemoglobin below 10 g/dL)
• People with an enlarged spleen
• People who have received chemotherapy or targeted cancer treatment within the past 28 days
• People who have received radiation therapy within the past 28 days
• People who have taken part in another clinical trial or used an unapproved medical device within the past 28 days
• People who have had an autologous stem cell transplant (using their own cells) within the past 84 days
• People who have had an allogeneic stem cell transplant (using a donor's cells) within the past 100 days
• People who have taken a medication containing 5-ALA (a specific compound used in some medical treatments) within the past 7 days, other than the study drug itself
• People who have eaten foods containing 5-ALA or St. John's Wort within the past 7 days
• People who have another current or previous separate cancer diagnosis
• People with serious health complications that are not well controlled
• People with a condition called porphyria (a rare disorder affecting the blood)
• People with heart rhythm problems or moderate-to-severe heart failure that are not well controlled
• People with uncontrolled heart, kidney, or liver failure, high blood pressure, or diabetes
• People with a psychological condition such as a mental illness, dementia, or depression
• People with certain active or unresolved hepatitis B or hepatitis C infections
• People with HIV
• People whose ATL has spread to the brain or spinal cord
• People with a specific abnormality in heart electrical activity detected on testing (QTcF above 470ms) (confirm with trial site)
• People with an active infection that is not well controlled
• People who are pregnant or breastfeeding
• People currently enrolled in another clinical trial
• People who participated in the Phase I part of this trial (for the Phase II portion only)
• Other conditions the trial doctors consider make participation unsuitable (confirm with trial site)

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