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:

• People who have been diagnosed with AML, MDS (including JMML), or certain bone marrow disorders (CMML, myelofibrosis, or MDS/MPN) that have come back or did not go away after a stem cell transplant, with measurable signs of disease still present.
• People whose disease is still present within 4 weeks before the planned cell treatment, and at least 2 weeks after finishing immune-suppressing medications, and at least 2 months after their stem cell transplant (with specific timing rules that the trial site can clarify).
• People whose original stem cell donor is still available, willing, and medically able to donate again through a non-mobilized collection process.
• People aged 12 years or older.
• People who are reasonably physically active and able to carry out daily activities, as measured by standard medical scales (ECOG score of 2 or below, or equivalent scores for younger patients).
• People whose blood cells are at least 20% from the original donor, tested within 4 weeks before the planned cell treatment.
• People whose bone marrow shows 80% or less disease involvement within 4 weeks before the planned cell treatment.
• People who have not been on steroid medications for a transplant-related immune complication called graft-versus-host disease (GVHD) for at least 4 weeks before the planned cell treatment, and who have been off certain immune-suppressing drugs (such as tacrolimus or sirolimus) for at least 4 weeks before treatment (small doses of steroids for unrelated reasons may be allowed — confirm with trial site).
• People who have not received any other treatments specifically targeting GVHD for at least 4 weeks before the planned cell treatment.
• People (or their legal guardians, for younger patients) who are able to understand and willing to sign a consent form agreeing to take part.
• People whose liver, kidneys, heart, and lungs are functioning adequately within 2 weeks of the planned cell treatment, based on specific blood test and imaging results (confirm exact thresholds with trial site).
• Women who could become pregnant must have a negative pregnancy test before joining.
• Women who could become pregnant, and men, must agree to use reliable contraception during the study and for a set period afterward; men must continue contraception for 4 months after the last dose of a medication called IL-2.

Who may not be able to join:

• People whose disease has spread to immune-protected areas of the body, such as the brain and spinal fluid, testes, or eyes.
• People who have received certain experimental treatments within 4 to 8 weeks before the planned cell treatment, or who are still experiencing side effects from recent treatments (specific timeframes apply depending on the treatment type — confirm with trial site).
• People who received a procedure called a Donor Lymphocyte Infusion (DLI) within 8 weeks before the planned cell treatment, or whose DLI led to a serious immune reaction (GVHD) requiring systemic treatment.
• People who have had a severe (grade 3 or 4) immune reaction called acute GVHD in the past, or who currently have active GVHD being treated with systemic medications.
• People who have received a solid organ transplant (such as a kidney or liver transplant).
• People who have had a known allergic reaction to medications similar to IL-2 or other drugs used in this trial.
• People with certain autoimmune conditions, including inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), rheumatoid arthritis, lupus, scleroderma, autoimmune blood vessel inflammation, or certain nerve conditions such as Guillain-Barré Syndrome or Myasthenia Gravis (people with Hashimoto's thyroiditis may still be eligible — confirm with trial site).
• People with serious uncontrolled illnesses, such as an active infection, severe heart problems, or significant mental health or social circumstances that would make it difficult to follow the trial schedule.
• People who become critically ill before or on the planned day of cell treatment, unless they recover and are reviewed by the trial's lead doctor (confirm with trial site).
• Women who are pregnant, because of unknown risks to the developing baby from the cell treatment and chemotherapy used in this trial.
• Women who are breastfeeding, as there is an unknown potential risk to nursing infants.
• People who are HIV-positive, due to risks related to drug interactions and serious infection.
• People with active, uncontrolled Hepatitis B, Hepatitis C, HIV, or HTLV-1 infection, due to high risk of serious liver-related complications.
• People with a history of another type of cancer, unless they have been in complete remission for at least 2 years, or have had certain limited cancers (such as non-spreading skin cancer or early prostate cancer not requiring chemotherapy) treated within the past 2 years (confirm specific circumstances with trial site).

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