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 must be 18 years old or older.
• You must be well enough to carry out most normal daily activities (confirm with trial site for specific fitness score requirement).
• You have been diagnosed with acute myeloid leukemia (AML) that has come back or has not responded to treatment, based on specific 2022 guidelines.
• Your kidneys must be working well enough, based on a blood test measuring kidney filtering ability.
• Your liver chemical levels in your blood must be within acceptable ranges (with some exceptions for certain liver conditions or disease-related causes — confirm with trial site).
• Your heart must be pumping blood effectively (above a certain threshold) and you must not have uncontrolled heart rhythm problems or severe heart failure symptoms.
• Your blood oxygen level must be at least 92% while breathing normal room air, without needing extra oxygen.
• Certain blood cell counts must meet minimum levels before a cell collection procedure; some of these can be supported with transfusions beforehand.
• Your doctor must expect you to live at least 12 weeks from the time you enroll.
• If you are a woman who could become pregnant, you must have a negative pregnancy test before joining.
• If you have previously had a bone marrow/stem cell transplant from a donor, it must have been completed at least 3 months before, you must have been off immune-suppressing medications for at least 2 weeks, and you must not have active transplant rejection symptoms (GVHD) requiring treatment.
• If you could become pregnant, you must agree to use effective birth control during the study and for 12 months after, and immediately tell your doctor if you become pregnant.
• You must already be considered a potential candidate for a future donor stem cell transplant, with possible donors already identified through a consultation at Roswell Park Comprehensive Cancer Center.
• You must understand that this is a research study and sign a written consent form before any study procedures begin.

Who may not be able to join:

• You are taking steroid medications (such as prednisone) at higher than a low daily dose around the time of cell collection or within 4 weeks of the treatment infusion (unless it is for transplant rejection symptoms).
• You have a specific type of leukemia called acute promyelocytic leukemia (APL).
• Your leukemia has spread to your brain or spinal fluid and is currently active (having had this in the past but now in full remission is generally acceptable).
• You have participated in another experimental treatment study within about 2 weeks before the cell collection procedure.
• You need certain stronger chemotherapy treatments (beyond a specified limited list of medications) to control your leukemia within about 2 weeks before treatment begins (confirm with trial site for the exact list of allowed medications).
• You have a serious infection, uncontrolled lung disease, or significant mental health or social concerns that are currently ongoing.
• You have HIV, or currently active hepatitis B or C infection.
• You have had another cancer within the past 2 years, with some exceptions such as certain treated skin cancers, surgically cured cervical cancer, or low-risk prostate cancer being monitored without treatment.
• You have moderate to severe transplant rejection symptoms (GVHD) that currently require treatment.
• You have previously received a transplant of a solid organ (such as a kidney or liver).
• You have an autoimmune disease that currently requires immune-suppressing medication.
• You are pregnant or currently breastfeeding.
• You are unwilling or unable to follow the study requirements.
• The trial doctor believes for any reason that you would not be a suitable candidate for this study.

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