Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Single-arm, single-center phase II trial to evaluate the antileukemic activity and safety/tolerability of TMLI/cyclophosphamide and etoposide conditioning regimen followed by allogeneic hematopoietic stem cell transplantation in patients with high-risk myelodysplastic syndrome or acute myeloid leukemia.

The use of web based self-assessment questionnaires as a complementary tool for conducting preoperative assessment (POA) is gaining increasing acceptance. Preanestes@s2.0 is a web based application fully developed by the investigators team which potentially allows for remote non-telephonic POA. It has already been evaluated as a feasible tool in terms of patient acceptance and quality of the information recorded. In this prospective two-arm study, the investigators will evaluate the incidence of suboptimal POA when the participants are evaluated through Preanestes@s2.0 versus the traditional outpatient face to face visit. The investigators will consider as suboptimal any POA that potentially may generate an inadequate preparation of the patient which may affect the expected results. A total 1.127 participants will be evaluated through Preanestes@s2.0 (intervention arm) and compared to a cohort of 1.127 patients evaluated by traditional face-to-face interview (non-intervention arm). The comparison will be made by means of a propensity score matching study. Patients included in both arms of the study will be recruited throughout the same period of time.

The goal of this clinical trial is to learn if drugs (fludarabine and melphalan) combinated with a targeted irradiation (in bone marrow and in lymphoid tissue) works to treat blood cancers (high risk myelodysplastic syndrome or acute myeloid leukemia) in adults. It will also learn about the safety of this combination of drugs and irradiation. The main questions it aims to answer are:
* Does this combined therapy result in an improved survival and decreased relapse/progression rate after a bone marrow transplant?
* What toxicities or complications do participants have when taking this combined therapy?
Researchers will use this combined therapy to see if it works to treat high risk myelodysplastic syndrome or acute myeloid leukemia through the evaluation of the length of time (during the treatment and 2 years after the treatment) that a patient lives with the disease but it does not get worse (progression-free survival).
Participants will:
* Receive the combined therapy (study treatment) one week before the bone marrow transplant.
* Receive too post-transplant medication as per usual clinical practice.
Patients will have to attend medical visits (checkups and tests) for 2 years.