TMLI Plus Chemotherapy in High Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-50
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla

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

Treatment groups

58 Participants
are divided into 1 treatment group