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

ConditionsMyelodysplastic SyndromesMyeloid Leukemia, Acute
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Total bone marrow and lymphoid irradiation/cyclophosphamide/etoposide

    Drug

    Evaluate the antileukemic activity of an total bone marrow and lymphoid irradiation/cyclophosphamide/etoposide conditioning regimen for allogeneic hematopoietic stem cell transplantation

Treatment groups

58 Participants
are divided into 1 treatment group
Group A: Single armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Overall survival

Quantification of time of patients who are still alive

Time frame
From the start of therapy to 2 years after post-transplant
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: