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 between 18 and 60 years old.
• People diagnosed with a specific type of blood cancer called acute myeloid leukemia (AML), not including the subtype known as M3, whose cancer has gone into complete remission and who are about to receive follow-up (consolidation) chemotherapy.
• People whose general physical functioning is rated as reasonably good by their doctor (on a standard scale from 0 to 2, where 0 is fully active and 2 is limited but able to care for oneself).
• People expected to live for at least 3 months.
• People whose heart, lungs, liver, and kidneys are functioning well enough to meet specific medical measurements (confirm with trial site for exact values).
• People who have not received any cancer treatment in the 2 weeks before joining, and whose side effects from earlier treatments have mostly resolved.
• People who are male or female, and who either have had surgical sterilisation, are post-menopausal, or are willing to use an accepted form of contraception during treatment and for 6 months afterward.
• People (or their legal guardian) who have read and understood the study information and have signed a consent form agreeing to take part.

Who may not be able to join:

• People whose leukemia had spread to the central nervous system (brain and spinal cord) at the time of diagnosis.
• People whose AML developed as a result of another condition or previous cancer treatment (secondary AML).
• People who have low blood cell counts caused by something other than cancer treatment.
• People who have previously had radiation therapy to the breastbone (sternum) or pelvis.
• People who have an active, uncontrolled infection at the time of joining the trial.
• People who have active, uncontrolled bleeding at the time of joining.
• People with serious ongoing health conditions affecting survival, such as severe malnutrition or significant weight loss.
• People expected to survive 48 hours or less.
• People with an active hepatitis B or hepatitis C infection.
• People with a current or past HIV infection.
• People with a syphilis infection.
• People who have been continuously taking immune-suppressing medications, or who have received an organ transplant in the past 6 months.
• People who have taken part in another clinical drug trial within the past 6 weeks.
• People who have previously taken part in any clinical research involving stem cells or exosomes.
• People who would need to take certain cell-division-blocking medications at the same time as the study treatment.
• People with serious allergies, or a known or suspected allergy to the study drug or its ingredients.
• People who have a known medical reason why they cannot receive blood growth factors, blood transfusions, or anti-infection medications.
• People who are pregnant or breastfeeding.
• People living with a diagnosed mental illness.
• People with a history of drug abuse or addiction.
• People who have had a different type of cancer (other than a blood cancer) within the past 3 years.
• People who have not signed the required consent form.
• People who are unlikely to be able to complete the full course of the study.
• People whose situation, in the opinion of the investigating doctor, could put them at greater risk or affect the reliability of the study results.
• People who are considered ineligible for any other reason, at the discretion of the investigating doctor.

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