About this trial
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.
Eligibility criteria
Qualifiers
The participant has the ability and willingness to sign the informed consent document
Age ≥18 to ≤50 years.
Karnofsky's performance status should be ≥70%.
Patients with myelodysplastic syndrome/acute myeloid leukemia or acute myeloid leukemia with relapsed/refractory active disease, or in complete remission or morphologic leukemia-free state with evidence of measurable residual disease as assessed by multiparameter flow cytometry (≥ 0,1%) or next-generation sequencing
Disqualifiers
Patients who have received a previous autologous (within the last year) or allogeneic transplant (at any time) are excluded
Previous radiation therapy, which would preclude the use of total bone marrow and lymphoid irradiation
Plans during the trial to receive any other investigational (non-trial-related) agents
Uncontrolled disease, including ongoing or active infection
Trial design
Treatments tested in this trial
- Total bone marrow and lymphoid irradiation/cyclophosphamide/etoposide