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:

• Adults aged 18 to 67 years old.
• People who have either a high-risk acute leukemia or a bone marrow disorder (myelodysplasia) where survival chances are expected to be less than 40% over 2 years with a standard stem cell transplant, OR people with a blood cancer that needs a stem cell transplant but for whom no suitable matched donor has been found.
• People for whom a suitable donated umbilical cord blood unit is available that meets specific matching and cell count requirements from an approved cord blood bank.
• People in good enough general health, as measured by a standard fitness score of 70% or above, with the specific health score limit depending on age and whether this is a second transplant.
• People whose heart is pumping adequately (at least 40% function), tested within the past 60 days.
• People whose lungs are working well enough (at least 50% of expected function), tested within the past 60 days.
• People whose liver is functioning within acceptable limits, tested within the past 60 days.
• People whose kidneys are filtering at an adequate level, tested within the past 60 days.
• People for whom a backup donor graft has already been identified before treatment begins.
• People who have given signed written consent to participate.
• Women who could become pregnant must have a negative pregnancy test within 30 days of enrolment and again within 30 days of starting the treatment, and must be willing to use effective contraception throughout the study.

Who may not be able to join:

• People who have had a full-intensity stem cell transplant (either from a donor or their own cells) within the last 6 months.
• People with an active infection (bacterial, viral, or fungal) that is not under control and is not responding to treatment.
• People who have another separate cancer (other than the one being treated) where survival at 5 years is expected to be less than 75%.
• People who are HIV positive.
• People with active Hepatitis B or C with detectable virus in the blood, or with Hepatitis B or C of any viral level unless it has been clearly confirmed there is no liver scarring (cirrhosis) through specific testing.
• People with liver cirrhosis (scarring of the liver).
• People whose immune system has developed certain antibodies against the donor cord blood unit above a specific level (confirm with trial site for details on this threshold).
• People who have used an experimental drug (one not approved by Health Canada or the FDA) within 30 days before starting chemotherapy, unless the trial sponsor has given specific approval.
• People who have 30% or more blast cells (abnormal immature blood cells) in their bone marrow, or a significant number circulating in their blood.
• People with active involvement of the cancer in the central nervous system (brain or spinal cord), or a tumour deposit larger than 2 cm.

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