Trials Sponsors Conditions Drugs Pricing

Conditions

Myelodysplastic Syndromes Myeloid Leukemia, Acute

Keywords

High-Risk myelodysplastic syndromeAcute myeloid leukemiaTotal narrow and lymphoid irradiation

Outcome Measures

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

Secondary Outcomes (9)

Overall survival
From the start of therapy to 2 years after post-transplant
Cumulative incidence of recurrence/progression
From the start of therapy to 2 years after post-transplant
Complete remission rate
From the day of infusion to the day 30 post-transplant
Non-relapse mortality
From the start of therapy until 2 years after post-transplant
Measurable residual disease
At 30, 90, 180 days and 1 year, 1.5 year and 2 years post-transplant
+4 more secondary outcomes

Study Arms (1)

Single arm

EXPERIMENTAL

This trial is designed to evaluate the antileukemic activity of an Total bone marrow and lymphoid irradiation/cyclophosphamide/etoposide conditioning regimen for allogeneic hematopoietic stem cell transplantation, in patients with high-risk myelodysplastic syndromes and acute myeloid leukemia, as assessed by 2-year progression-free survival. The first 6-18 patients enrolled/treated in this study will be part of a safety sub-analysis, so patients will be assigned to the dose level that is currently open once they are verified to be eligible; up to three dose levels can be studied.

Drug: Total bone marrow and lymphoid irradiation/cyclophosphamide/etoposide

Interventions

Total bone marrow and lymphoid irradiation/cyclophosphamide/etoposideDrug

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

Single arm

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Total bone marrow and lymphoid irradiation/cyclophosphamide/etoposide
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

The participant has the ability and willingness to sign the informed consent document
Age ≥18 to ≤50 years.

Sponsors & Collaborators

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Otherlead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Jose-Antonio Perez-SimonCONTACT0034955013260 ext. 0034 josea.perez.simon.sspa@juntadeandalucia.es

MeSH Terms

Conditions

Myelodysplastic SyndromesLeukemia, Myeloid, Acute

Interventions

Lymphatic Irradiation

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

José Antonio Pérez Simón, MD-PhD
Fundación para la Gestión de la Investigación en Salud de Sevilla
PRINCIPAL INVESTIGATOR

Central Study Contacts

José Antonio Pérez Simón, MD-PhD

CONTACT

+34955013260 josea.perez.simon.sspa@juntadeandalucia.es

Clara M Rosso Fernández, MD-PhD

CONTACT

+34955013414

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 28, 2024

First Posted

September 19, 2024

Study Start

December 30, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (1)

Single arm

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (1)

Single arm

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations