Summary
People who have been diagnosed with a blood cancer that has a risk of relapse, (e.g. Acute Myeloid Leukemia, Myeloid Dysplastic Syndrome, Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia, Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma) may benefit from having a transplant of healthy stem cells into their bone marrow to encourage their body to produce healthy cells.
This treatment has a high risk of transplant rejection and so patients often need to take immuno-suppressing drugs for a time before and after the transplant to ensure the transplant is not rejected.
This study aims to assess 4 different immuno-suppressing treatment regimes (drugs and body irradiation/radiotherapy) to determine which treatment is best at suppressing the rejection response without compromising the overall health of the patient.
Who is it for?
You may be eligible for this study if you are aged 16 to 75 years of age, you have been diagnosed with a blood cancer that has a risk of relapse and your doctor has recommended that a stem cell transplant is indicated. You may also need to meet additional criteria (heart, lung and kidney health criteria) in order to be eligible for this study.
Study details
Participants in this study will take part in one of two separate sub-studies. The decision of which of the two sub-studies a participant will take part in is at the discretion of the study investigator. The two sub-studies are:
1. Reduced Intensity Conditioning (RIC) -Sub-study 1: contains two sequential treatment arms. The first treatment arms.will examine using will use standard of care radiation but at a higher dose with fludarabine. The second treatment arm will use of treosulfan instead of standard of care busulfan with fludarabine. Patients will have scans and blood tests before and after the transplant. Medical review will occur daily whilst in hospital and then once discharged as medically required (may start weekly then monthly)
2 Myeloablative Conditioning (MAC) - Sub-study 2: contains 2 treatment arms running concurrently. One will use of treosulfan instead of standard of care busulfan with fludarabine and the other will use standard of care radiation but at a higher dose. Patients will have scans and blood tests before and after the transplant. Medical review will occur daily whilst in hospital and then once discharged as medically required ( may start weekly then monthly)
It is hoped this research will demonstrate that one (or many) of the treatment regimes tested is safe for cancer patients and effective at keeping the transplant rejection response rate low. The best treatment regime may then be tested in a larger randomised trial that could benefit future patients with blood cancers.