Phase 2 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:

• You are 18 years old or older
• You received a stem cell transplant from a donor for acute myeloid leukemia (AML) or a bone marrow disorder called MDS, and your donor's tissue type closely matched yours (at least 8 out of 8 markers)
• Your AML or MDS has come back after your transplant, and tests show a measurable amount of disease — this can be confirmed by a bone marrow biopsy, blood cell analysis, chromosome testing, or a specific gene test (confirm with trial site for which test applies to you)
• You are well enough to carry out basic daily activities (your doctor can confirm this with a simple performance scale)
• Donor immune cells (called lymphocytes) are available for you, either already collected or your donor is willing to have them collected
• If you received treatment for your relapse after the transplant, it was only one course of treatment, and enough time has passed since your last dose (the required waiting period depends on the type of treatment you received — confirm with trial site)
• You are willing and able to follow all study requirements for the full duration of the trial
• You have signed a consent form agreeing to take part
• If you are a woman under 55 and have not had a hysterectomy, removal of your ovaries, or confirmed menopause, you are willing to use two forms of birth control (including one highly effective method) throughout the study
• If you are a man, you and your female partner are willing to use effective birth control throughout the study

Who may not be able to join:

• Your body did not successfully accept the transplanted stem cells in the first place (primary engraftment failure)
• You currently have severe acute graft-versus-host disease (a serious reaction where the donor cells attack your body), rated as Grade 3 or 4
• You have previously had the most severe form (Grade 4) of acute graft-versus-host disease at any point
• You currently have moderate or severe long-term (chronic) graft-versus-host disease
• You have taken any medications that suppress your immune system in the past 2 weeks
• You are currently experiencing significant side effects (Grade 3 or higher) from a previous treatment
• You have a known allergy or sensitivity to the study drug (IFN-γ) or any of its ingredients, including products derived from E. coli bacteria
• You are pregnant or currently breastfeeding
• You have an uncontrolled heart rhythm problem, or you have had moderate-to-severe heart failure in the past 2 months (unless a specific type of rhythm issue is now under control — confirm with trial site)
• You have active heart disease related to reduced blood flow that is not controlled with medication within the past 2 months
• You have a lung condition that requires you to use oxygen continuously
• You have a seizure disorder that has not been well controlled with medication in the past 2 months
• Your liver test results are significantly above the normal range at the time of joining
• Your kidneys are not working well enough (below a certain level measured by a standard formula — confirm with trial site)
• Your body surface area (a measure based on your height and weight) is either too small or too large for the standard dosing used in this trial (confirm with trial site)

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