This study involves patients with acute lymphoblastic leukemia, which is a type of blood cancer that affects white blood cells. The study focuses on children, teenagers, and young adults up to 25 years of age who need a stem cell transplant, which is a procedure where diseased bone marrow is replaced with healthy stem cells from a donor. The study will use several different medications including ruxolitinib, which is taken by mouth as a tablet or liquid, blinatumomab, which is given through a vein, and various chemotherapy medicines such as treosulfan, busulfan, fludarabine, cyclophosphamide, etoposide, and thiotepa. Some patients will also receive medicines to help prevent complications after transplant, including anti-t lymphocyte immunoglobulin and methylprednisolone, which is a type of steroid medicine. Some patients in the study may receive a lower dose of radiation treatment called total body irradiation before their transplant.
The purpose of this study is to find better ways to perform stem cell transplants in young patients with acute lymphoblastic leukemia by reducing side effects and complications while still keeping the transplant effective at preventing the cancer from coming back. The study will test different approaches, including whether a lower dose of radiation works as well as a higher dose, whether adding ruxolitinib to steroids helps treat a complication called graft-versus-host disease, which happens when the donor cells attack the patient’s body, and whether giving blinatumomab after transplant helps prevent the cancer from returning in very young children. The study will also compare different types of donors and different ways to prepare patients for transplant.
Patients will be followed for several years after their transplant to see how well the treatments work. During the study, patients will receive their transplant preparation treatment over several days, followed by the stem cell transplant itself. Some patients may receive additional treatment after transplant depending on which part of the study they are in. For example, patients receiving ruxolitinib for graft-versus-host disease may take this medicine for up to 24 weeks, while very young children may receive up to four cycles of blinatumomab treatment after their transplant. Throughout the study, patients will have regular check-ups and tests to monitor their progress and watch for any side effects or complications.



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