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PHASE II STUDY OF TOTAL MARROW AND LYMPHOID IRRADIATION (TMLI) ADMINISTERED IN COMBINATION WITH A MYELOABLATIVE REGIMEN BASED ON CYCLOPHOSPHAMIDE AND ETOPOSIDE AS A CONDITIONING FOR ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION (AHSCT) IN PATIENTS WITH HIGH-RISK MYELODYSPLASTIC SYNDROME OR ACUTE MYELOID LEUKEMIA

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514484-25-00
Acronym
TMLI-MA
Enrollment
49
Registered
2024-11-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-Risk Myelodisplastic Syndrome or Acute Myeloid Leukemia

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

DRUGMYCOPHENOLATE MOFETIL
DRUGTACROLIMUS
DRUGETOPOSIDE
DRUGCYCLOPHOSPHAMIDE
DRUGSIROLIMUS

Sponsors

Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026