High-Risk Myelodisplastic Syndrome or Acute Myeloid Leukemia
Conditions
Brief summary
Toxicity, which will be graded on both the Bearman Scale and the NCI CTCAE Scale v5.0, The evaluation of 2-year PFS. PFS will be defined as time from the start of treatment to the ate of death, disease relapse/progression, or date of last follow-up, and estimated using the Kaplan-Meier method
Detailed description
Overall survival (OS): patients are considered a failure for this endpoint if they die, regardless of the cause. The time to this event is the time from the start of protocol therapy to death, or the last follow-up, whichever comes first, Cumulative incidence (CI) of recurrence/progression: The event is relapse/progression either extramedullary (EM) or at bone marrow (BM) (date and place). The time to this event is measured from the start of therapy. Death without relapse/progression is considered a competing risk. Surviving patients with no history of relapse/progression are censored at the time of last follow-up, Complete remission (CR) rate at day 30 post-transplant: The event is whether or not the patient has a documented CR on day 30, Non-relapse mortality (NRM2. NRM is measured from the start of therapy until non-disease-related death, or the last follow-up, whichever comes first, Measurable residual disease (MRD): MRD monitoring assessed by multiparameter flow cytometry at 30, 90, 180, 360, 575 days, and 2 years post-transplant, Incidence of infection: Microbiologically documented infections will be reported by site of illness, date of onset, severity, and resolution, if applicable. This data will be captured through the case report form and will be collected from day 0 to 100 days after transplantation, Toxicities/Adverse Events: The Bearman Scale (non-hematologic) and CTCAE v. 5.0 (hematologic) will be employed. Dose/dose-volume toxicity characterization across organs will be assessed, Acute graft-versus-host disease (GVHD) grades 2-4 and 3-4:. The endpoint will be assessed from day 0 to 100 days post-transplant, Chronic graft-versus-host disease (GVHD): Chronic graft-versus-host disease is graded according to the NIH consensus staging. The first day of onset of chronic GVHD will be used to calculate cumulative incidence curves
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity, which will be graded on both the Bearman Scale and the NCI CTCAE Scale v5.0, The evaluation of 2-year PFS. PFS will be defined as time from the start of treatment to the ate of death, disease relapse/progression, or date of last follow-up, and estimated using the Kaplan-Meier method | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS): patients are considered a failure for this endpoint if they die, regardless of the cause. The time to this event is the time from the start of protocol therapy to death, or the last follow-up, whichever comes first, Cumulative incidence (CI) of recurrence/progression: The event is relapse/progression either extramedullary (EM) or at bone marrow (BM) (date and place). The time to this event is measured from the start of therapy. Death without relapse/progression is considered a competing risk. Surviving patients with no history of relapse/progression are censored at the time of last follow-up, Complete remission (CR) rate at day 30 post-transplant: The event is whether or not the patient has a documented CR on day 30, Non-relapse mortality (NRM2. NRM is measured from the start of therapy until non-disease-related death, or the last follow-up, whichever comes first, Measurable residual disease (MRD): MRD monitoring assessed by multiparameter flow cytometry at 30, 9 | — |
Countries
Spain