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 aim of this study is the evaluation of the antitumor activity of the conditioning regimen with TMLI, cyclophosphamide and etoposide followed by allogeneic hematopoietic stem cell transplantation by means of the progression-free survival at 2 years after a safety-lead phase. The determination of the complete remission rate at day 30 post-transplant, the estimation of overall survival, the cumulative incidence of recurrence/progression, and non-relapse mortality at 100 days, 1 year, and 2 years, the Minima Residual Disease monitoring at 30, 90, 180, 270 days and 1 year, 1 year and a half and 2 years post-transplant, and the assessment early and late toxicities/complications by organ and severity, as well as dose/dose-volume toxicity characterization across organs, including acute/chronic graft-versus-host disease, infection, and long-term complications are included as secondary objectives.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
58
Evaluate the antileukemic activity of an total bone marrow and lymphoid irradiation/cyclophosphamide/etoposide conditioning regimen for allogeneic hematopoietic stem cell transplantation
Hospital Universitario Virgen del Rocío
Seville, Spain
Progression-free survival
Time from the start of treatment to the date of death, disease relapse/progression, or date of last follow-up.
Time frame: From the start of therapy to 2 years after post-transplant
Overall survival
Quantification of time of patients who are still alive
Time frame: From the start of therapy to 2 years after post-transplant
Cumulative incidence of recurrence/progression
The event is relapse/progression either extramedullary or at bone marrow
Time frame: From the start of therapy to 2 years after post-transplant
Complete remission rate
The event is whether or not the patient has a documented complete remission
Time frame: From the day of infusion to the day 30 post-transplant
Non-relapse mortality
Number of deaths from causes other than relapse or progression
Time frame: From the start of therapy until 2 years after post-transplant
Measurable residual disease
Measurable residual disease monitoring assessed by multiparameter flow cytometry
Time frame: At 30, 90, 180 days and 1 year, 1.5 year and 2 years post-transplant
Incidence of infection
Describe the infections.
Time frame: 2 years after post-transplant
Adverse Events
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Describe the adverse event
Time frame: 2 years after post-transplant
Acute graft-versus-host disease grades 2-4 and 3-4
This point is classified according to the consensus MAGIC classification
Time frame: 100 days post-transplant
Chronic graft-versus-host disease
Describe the chronic graft-versus-host disease according to the National Institutes of Health Stroke Scale consensus staging.
Time frame: 2 years after post-transplant