EVALUACIÓN DE LA INFLUENCIA DEL TRATAMIENTO PROFILÁCTICO ANTICONVULSIONANTE A LA EXPOSICIÓN SANGUÍNEA CON BUSULFAN EN PACIENTES ADULTOS CON NEOPLASIAS HEMATOLÓGICAS QUE RECIBEN (BU IV) MAS CICLOFOSFAMIDA (CI) COMO RÉGIMEN DE ACONDICIONAMIENTO PREVIO AL TRASPLANTE DE CÉLULAS MADRES (TCM) ALOGÉNICO.

Datos básicos

Código:
F60002IN201GO
Protocolo:
F60002IN201GO
EUDRACT:
NO ENCUENTRO
NCT:
Centro:
Dotación:
Año de incio:
Año de finalización:
ENSAYO CLÍNICO

Documentos

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Participantes

Grupos

Financiadores - Promotores

PIERRE FABRE IBERICA S.A.

Resultados del Ensayo Clínico


A predictive algorithm using clinical and laboratory parameters may assist in ruling out and in diagnosing MDS

Oster, HS; (...); Mittelman, M

Article. 10.1182/bloodadvances.2020004055. 2021

  • Open Access.

A sex-informed approach to improve the personalised decision making process in myelodysplastic syndromes: a multicentre, observational cohort study

Maggioni, Giulia; (...); Della Porta, Matteo G.

Article. 10.1016/S2352-3026(22)00323-4. 2023

  • Open Access.

A Single-Run Next-Generation Sequencing (NGS) Assay for the Simultaneous Detection of Both Gene Mutations and Large Chromosomal Abnormalities in Patients with Myelodysplastic Syndromes (MDS) and Related Myeloid Neoplasms

Liquori, A; (...); Cervera, J

Article. 10.3390/cancers13081947. 2021

  • Open Access.

A STEP TOWARDS IDENTIFICATION AND CAUSAL INTERPRETATION OF THERAPY-RELATED MDS (T-MDS)

Kuendgen, A.; (...); Sanz, G.

Meeting Abstract. 10.1016/j.leukres.2023.107226. 2023


ACCELERATED FAILURE TIME MODELS AS A CLINICALLY PLAUSIBLE WAY TO DESCRIBE SURVIVAL IN MDS - AN ANALYSIS OF THE IWG-PM DATABASE

Pfeilstoecker, M.; (...); Greenberg, P.

Meeting Abstract. 10.1016/j.leukres.2023.107230. 2023


An agenda to advance research in myelodysplastic syndromes: a TOP 10 priority list from the first international workshop in MDS

Stahl, Maximilian; (...); Zeidan, Amer M.

Letter. 10.1182/bloodadvances.2022008747. 2023

  • Open Access.

Building a Healthcare Alliance for Resourceful Medicine Offensive Against Neoplasms in HematologY Added Value Framework for Hematologic Malignancies: A Comparative Analysis of Existing Tools.

Cerisoli, Francesco; (...); Hernandez Rivas, Jesus Maria

Article. 10.1016/j.jval.2022.04.1729. 2022

  • Open Access.

Cause of death and excess mortality in patients with lower-risk myelodysplastic syndromes (MDS): A report from the European MDS registry.

Madry, Krzysztof; (...); Smith, Alex

Article. 10.1111/bjh.18542. 2022


Classification, risk stratification and response assessment in myelodysplastic syndromes/neoplasms (MDS): A state-of-the-art report on behalf of the International Consortium for MDS (icMDS).

Stahl M; (...); Zeidan AM

Article. 10.1016/j.blre.2023.101128. 2023

  • Open Access.

Clinical and Biological Characterization of Low Risk MDS Patients According to Ring Sideroblasts (RS). Comparison between the 3 Subgroups in WHO2017 Classification. Study from the Spanish MDS Registry

Lopez Cadenas, Felix; (...); Diez-Campelo, Maria

Meeting Abstract. 10.1182/blood-2021-152678. 2021

  • Open Access.

Clinical and Genomic-Based Decision Support System to Define the Optimal Timing of Allogeneic Hematopoietic Stem-Cell Transplantation in Patients With Myelodysplastic Syndromes.

Tentori CA; (...); Della Porta MG

Article. 10.1200/JCO.23.02175. 2024

  • Open Access.

Clinical Implications of p53 Dysfunction in Patients with Myelodysplastic Syndromes

Riva, Elena; (...); Della Porta, Matteo G.

Meeting Abstract. 10.1182/blood-2022-166050. 2022

  • Open Access.

CLINICAL-BIOLOGICAL AND PROGNOSTIC CHARACTERISTICS OF LOW RISK SMD WITHOUT RING SIDEROBLASTS AND COMPARISON WITH ITS COUNTERPART WITH RING SIDEROBLASTS

Cadenas Felix, Lopez; (...); Ferreiras David, Valcarcel

Meeting Abstract. 2021

  • Open Access.

COMPARISON OF CYTOGENETIC ABERRATIONS IN 1590 PATIENTS WITH THERAPY-RELATED MDS (T-MDS) AND 4738 PATIENTS FROM THE REVISED INTERNATIONAL PROGNOSTIC SCORING SYSTEM DATABASE WITH PRIMARY-MDS (P-MDS)

Kuendgen, A.; (...); Sanz, G.

Meeting Abstract. 2021


COMPARISON OF THREE PANELS OF NGS APPLICATION IN ONCOHEMATOLOGY TO DISCARD SOMATIC AND/OR GERMINAL VARIANTS

Guzman-Gimenez, C.; (...); Such, E.

Meeting Abstract. 2021

  • Open Access.

Consensus proposal for revised International Working Group response criteria for higher risk myelodysplastic syndromes.

Zeidan, Amer M.; (...); Fenaux, Pierre

Article. 10.1182/blood.2022018604. 2023

  • Open Access.

Contemporary Approach to The Diagnosis and Classification of Myelodysplastic Neoplasms/Syndromes- Recommendations from The International Consortium for MDS (icMDS).

Aakash, Fnu; (...); Loghavi, Sanam

Article. 10.1016/j.modpat.2024.100615. 2024


CO-OCCURRENCE PROFILES OF GERMLINE AND ACQUIRED VARIANTS IN MYELODYSPLASTIC SYNDROMES IN YOUNG ADULTS WITHOUT PRIOR ORGAN DYSFUNCTION

Hua, Chen-Liang Tzu; (...); Andres, Jerez

Meeting Abstract. 2021

  • Open Access.

Cryopreservation of Allogeneic Hematopoietic Progenitor Cells in The Current SARS-Cov-2 Pandemic: Experience of A Single Centre

Moreno, D; (...); Carpio, N

Meeting Abstract. 2021


Current landscape of translational and clinical research in myelodysplastic syndromes/neoplasms (MDS): Proceedings from the 1st International Workshop on MDS (iwMDS) Of the International Consortium for MDS (icMDS).

Bewersdorf, Jan Philipp; (...); Zeidan, Amer M.

Article. 10.1016/j.blre.2023.101072. 2023

  • Open Access.

Data-driven, harmonised classification system for myelodysplastic syndromes: a consensus paper from the International Consortium for Myelodysplastic Syndromes.

Komrokji RS; (...); Della Porta MG

Article. 10.1016/S2352-3026(24)00251-5. 2024


Determinants of low health-related quality of life in patients with myelodysplastic syndromes: EUMDS Registry study.

Stojkov I; (...); Siebert U

Article. 10.1182/bloodadvances.2022008360. 2023

  • Open Access.

Disease Characteristics and International Prognostic Scoring Systems (IPSS, IPSS-R, IPSS-M) in Adult Patients with Higher-Risk Myelodysplastic Syndromes (MDS) Participating in Two Randomized, Double-Blind, Placebo-Controlled Studies with Intravenous Sabatolimab Added to Hypomethylating Agents (HMA) (STIMULUS-MDS1 and MDS2)

Santini, Valeria; (...); Zeidan, Amer M.

Meeting Abstract. 10.1182/blood-2022-160282. 2022

  • Open Access.

Does RAD21 Co-Mutation Have a Role in DNMT3A Mutated AML? Results of Harmony Alliance AML Database

Azibeiro Melchor, Raul; (...); Ossenkoppele, Gert J.

Meeting Abstract. 10.1182/blood-2021-150766. 2021

  • Open Access.

Dynamics of Mortality and Transformation Risk within Different Risk Groups of Patients with Myelodysplastic Syndromes Stratified According to the IPSS-R - Comparison of Treated and Untreated Patients and Consequences for the Description of Risk Categories

Pfeilstocker, Michael; (...); Greenberg, Peter L.

Meeting Abstract. 10.1182/blood-2022-158671. 2022

  • Open Access.

Enhancing Cytogenetic Diagnostics: Incorporating Optical Genome Mapping in the Laboratory Routine

Diaz-Gonzalez, Alvaro; (...); Such, Esperanza

Meeting Abstract. 10.1182/blood-2023-180691. 2023

  • Open Access.

Epidemiology of Hereditary Thrombotic Thrombocytopenic Purpura (TTP) in Spain: Preliminary Results of a Study of the Spanish TTP Registry (REPTT)

Segui, Ines Gomez; (...); Garma, Julio Del Rio

Meeting Abstract. 2024


Evaluation of Lenalidomide (LEN) Vs Placebo in Non-Transfusion Dependent Low Risk Del(5q) MDS Patients. Final Results of Sintra-REV Phase III International Multicenter Clinical Trial

Lopez Cadenas, Felix; (...); Diez-Campelo, Maria

Meeting Abstract. 10.1182/blood-2022-168718. 2022

  • Open Access.

Finding consistency in classifications of myeloid neoplasms: a perspective on behalf of the International Workshop for Myelodysplastic Syndromes.

Zeidan, Amer M.; (...); Santini, Valeria

Article. 10.1038/s41375-022-01724-9. 2022

  • Open Access.

Generation of Multimodal Longitudinal Synthetic Data By Artificial Intelligence to Improve Personalized Medicine in Hematology

D'Amico, Saverio; (...); Della Porta, Matteo Giovanni

Meeting Abstract. 10.1182/blood-2024-209541. 2024


GENOMIC CLASSIFICATION OF MYELODYSPLASTIC SYNDROMES

Bernard, E.; (...); Papaemmanuil, E.

Meeting Abstract. 10.1016/j.leukres.2023.107146. 2023


Guadecitabine vs TC in relapsed/refractory AML after intensive chemotherapy: randomized phase 3 ASTRAL-2 trial.

Roboz GJ; (...); Döhner H

Article. 10.1182/bloodadvances.2023012062. 2024

  • Open Access.

Harmony Alliance Provides a Machine Learning Researching Tool to Predict the Risk of Relapse after First Remission in AML Patients Treated without Allogeneic Haematopoietic Stem Cell Transplantation

Sobas, Marta; (...); Maria Hernandez-Rivas, Jesus

Meeting Abstract. 10.1182/blood-2021-149521. 2021

  • Open Access.

Immune reconstitution after single-unit umbilical cord blood transplantation using anti-thymoglobulin and myeloablative conditioning in adults with hematological malignancies.

Cordón L; (...); Sanz J

Article. 10.1007/s00277-024-05758-0. 2024


Immune Reconstitution Profiling Suggests Antiviral Protection After Transplantation with Omidubicel: a Phase 3 Substudy.

Szabolcs, Paul; (...); Horwitz, Mitchell E.

Article. 10.1016/j.jtct.2023.04.018. 2023

  • Open Access.

Impact of Gender on Molecular AML Subclasses - a Harmony Alliance Study

Matteuzzi, Tommaso; (...); Bullinger, Lars

Meeting Abstract. 10.1182/blood-2021-152215. 2021

  • Open Access.

Implications of TP53 allelic state for genome stability, clinical presentation and outcomes in myelodysplastic syndromes (vol 26, pg 1549, 2020)

Bernard, Elsa; (...); Elias, Harold K

Article. 10.1038/s41591-021-01367-w. 2021

  • Open Access.

Incidence and prognostic impact of U2AF1 mutations and other gene alterations in myelodysplastic neoplasms with isolated 20q deletion.

Castillo MI; (...); Díaz TM

Article. 10.1002/cam4.6300. 2023

  • Open Access.

Incidence, Clinical Associations, and Co-Mutation Patterns of UBA1 Mutations in MDS

Sirenko, Maria; (...); Papaemmanuil, Elli

Meeting Abstract. 10.1182/blood-2022-162397. 2022

  • Open Access.

LAG3 genotype of the donor and clinical outcome after allogeneic transplantation from HLA-identical sibling donors.

Cruz, David; (...); Gallardo, David

Article. 10.3389/fimmu.2023.1066393. 2023

  • Open Access.

Longitudinal outcomes of obeticholic acid therapy in ursodiol-nonresponsive primary biliary cholangitis: Stratifying the impact of add-on fibrates in real-world practice.

Gomez, E; (...); Fernandez-Rodriguez, C M

Article. 10.1111/apt.18004. 2024

  • Open Access.

Lymphoid and myeloid immune cell reconstitution after nicotinamide-expanded cord blood transplantation

de Koning, Coco; (...); Nierkens, Stefan

Article. 10.1038/s41409-021-01417-4. 2021

  • Open Access.

LYMPHOPENIA IS HIGHLY PREVALENT IN MDS AND PROVIDES ADDITIONAL PROGNOSTIC INFORMATION FOR IPSS-R VERY-LOW AND LOW-RISK PATIENTS. AN ANALYSIS FROM THE EU-MDS REGISTRY

Silzle, T.; (...); Smith, A.

Meeting Abstract. 2021


Lymphopenia is highly prevalent in MDS and provides prognostic information for IPSS-R (very)-low-risk patients. An analysis from the EU-MDS registry

Silzle, T.; (...); Smith, A.

Meeting Abstract. 2021


Machine Learning Allows the Identification of New Co-Mutational Patterns with Prognostic Implications in NPM1 Mutated AML - Results of the European Harmony Alliance

Hernandez Sanchez, Alberto; (...); Bullinger, Lars

Meeting Abstract. 10.1182/blood-2022-167138. 2022

  • Open Access.

Machine Learning Provides Individualized Prediction of Outcomes after First Complete Remission in Adult AML Patients - Results from the Harmony Platform

Hernandez Sanchez, Alberto; (...); Bullinger, Lars

Meeting Abstract. 10.1182/blood-2023-183029. 2023


Management of adult patients with CMML undergoing allo-HCT: recommendations from the EBMT PH&G Committee.

Onida F; (...); Pleyer L

Article. 10.1182/blood.2023023476. 2024

  • Open Access.

Management of MDS with Isolated Del(5q) Patients in the European MDS (EUMDS) Registry, a Unique Prospective Real-World Dataset

Bowen, David; (...); de Witte, Theo M.

Meeting Abstract. 10.1182/blood-2021-150322. 2021

  • Open Access.

Management of MDS with Isolated Del(5q) Patients in the European MDS (EUMDS) Registry: A Report on 197 Cases

Smoljanovic, Inga Mandac; (...); Bowen, David

Meeting Abstract. 10.1182/blood-2022-167716. 2022


Managing hematological cancer patients during the COVID-19 pandemic: an ESMO-EHA Interdisciplinary Expert Consensus.

Buske C; (...); Passamonti F

Article. 10.1016/j.esmoop.2022.100403. 2022

  • Open Access.

Molecular and clinical presentation of UBA1-mutated myelodysplastic syndromes.

Sirenko, Maria; (...); Papaemmanuil, Elli

Article. 10.1182/blood.2023023723. 2024


Molecular Taxonomy of Myelodysplastic Syndromes and Its Clinical Implications

Bernard, Elsa; (...); Papaemmanuil, Elli

Meeting Abstract. 10.1182/blood-2023-186863. 2023

  • Open Access.

Molecular Taxonomy of Myelodysplastic Syndromes and its Clinical Implications.

Bernard, Elsa; (...); Papaemmanuil, Elli

Article. 10.1182/blood.2023023727. 2024


Multicenter Long-Term Follow-Up of Allogeneic Hematopoietic Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials.

Lin, Chenyu; (...); Horwitz, Mitchell E.

Article. 10.1016/j.jtct.2023.01.031. 2023

  • Open Access.

Myelodysplastic syndromes with 20q deletion: incidence, prognostic value and impact on response to azacitidine of ASXL1 chromosomal deletion and genetic mutations

Martin, I; (...); Tormo, M

Article. 10.1111/bjh.17675. 2021


National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies

Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis

Meeting Abstract. 10.1182/blood-2022-169938. 2022

  • Open Access.

Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study.

Horwitz, ME; (...); Sanz, G

Article. 10.1182/blood.2021011719. 2021

  • Open Access.

Outcomes and effect of somatic mutations after erythropoiesis stimulating agents in patients with lower-risk myelodysplastic syndromes.

Caballero, Juan Carlos; (...); Diez Campelo, Maria

Article. 10.1177/20406207231218157. 2024

  • Open Access.

Panel Sequencing for Clinically Oriented Variant Screening and Copy Number Detection in Chronic Lymphocytic Leukemia Patients

Ibanez, Mariam; (...); Luna I

Article. 10.3390/diagnostics12040953. 2022

  • Open Access.

PAN-STAKEHOLDER CORE OUTCOME SET (COS) DEFINITION FOR HEMATOLOGICAL MALIGNANCIES IN THE FRAMEWORK OF THE EU PROJECT, HARMONY: THE HEALTHCARE ALLIANCE FOR RESOURCEFUL MEDICINE OFFENSIVE AGAINST NEOPLASMS IN HEMATOLOGY

Lang, K.; (...); Bullinger, L.

Meeting Abstract. 2023


Pan-Stakeholder Core Outcome Set (COS) Definition for Hematological Malignancies within the Framework of Harmony and Harmony PLUS Projects

Lang, Katharina M.; (...); Bullinger, Lars

Meeting Abstract. 10.1182/blood-2022-157549. 2022

  • Open Access.

Pan-Stakeholder Core Outcome Set (COS) Definition for Selected Hematological Malignancies - Results of the Harmony Alliance

Lang, Katharina M.; (...); Bullinger, Lars

Meeting Abstract. 10.1182/blood-2021-145002. 2021

  • Open Access.

PCR-Based Strategy for Introducing CRISPR/Cas9 Machinery into Hematopoietic Cell Lines.

González-Romero E; (...); Vázquez-Manrique RP

Article. 10.3390/cancers15174263. 2023

  • Open Access.

Phase I trials of the lysine-specific demethylase 1 inhibitor, GSK2879552, as mono- and combination-therapy in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndromes.

Roboz, Gail J.; (...); Wei, Andrew H.

Letter. 10.1080/10428194.2021.2012667. 2022

  • Open Access.

Randomized Phase 1-2 Study to Assess Safety and Efficacy of Low-Dose (LD) Oral Decitabine/ Cedazuridine (ASTX727) in Lower-Risk Myelodysplastic Syndromes (LR-MDS) Patients: Interim Safety Analysis

Garcia-Manero, Guillermo; (...); Yacoub, Abdulraheem

Meeting Abstract. 2023


RANDOMIZED PHASE 2 STUDY TO ASSESS SAFETY AND EFFICACY OF LOW-DOSE (LD) ORAL DECITABINE/CEDAZURIDINE (ASTX727) IN LOWER-RISK MYELODYSPLASTIC SYNDROMES (LR-MDS) PATIENTS: INTERIM SAFETY ANALYSIS

Garcia-Manero, G.; (...); Yacoub, A.

Meeting Abstract. 10.1016/j.leukres.2023.107270. 2023


Real-World Validation of Molecular International Prognostic Scoring System (IPSS-M) for Myelodysplastic Syndromes

Sauta, Elisabetta; (...); Della Porta, Matteo G.

Meeting Abstract. 10.1182/blood-2022-163634. 2022

  • Open Access.

Real-World Validation of Molecular International Prognostic Scoring System for Myelodysplastic Syndromes.

Sauta, Elisabetta; (...); Della Porta, Matteo Giovanni

Article. 10.1200/JCO.22.01784. 2023

  • Open Access.

Rearrangements involving 11q23.3/KMT2A in adult AML: mutational landscape and prognostic implications - a HARMONY study.

Hernandez-Sanchez, Alberto; (...); Bullinger, Lars

Article. 10.1038/s41375-024-02333-4. 2024

  • Open Access.

Rearrangements Involving 11q23/KMT2A: Mutational Landscape and Prognostic Implications - Results of the Harmony Alliance AML Database

Hernandez Sanchez, Alberto; (...); Bullinger, Lars

Meeting Abstract. 10.1182/blood-2022-167480. 2022

  • Open Access.

Response to azacitidine in patients with chronic myelomonocytic leukemia according to overlap myelodysplastic/myeloproliferative neoplasms criteria*

Triguero, A.; (...); Sanz, G.

Article. 10.1016/j.leukres.2022.106836. 2022


Results from a Global Randomized Phase 3 Study of Guadecitabine (G) Vs Treatment Choice (TC) in 302 Patients with Relapsed or Refractory (r/r) Acute Myeloid Leukemia after Intensive Chemotherapy (ASTRAL-2 Study)

Roboz, Gail J.; (...); Dohner, Hartmut

Meeting Abstract. 10.1182/blood-2021-147769. 2021

  • Open Access.

Sabatolimab (MBG453) Combination Treatment Regimens for Patients (Pts) with Higher-Risk Myelodysplastic Syndromes (HR-MDS): The MDS Studies in the Stimulus Immuno-Myeloid Clinical Trial Program

Zeidan, Amer M.; (...); Garcia-Manero, Guillermo

Meeting Abstract. 10.1182/blood-2021-145626. 2021

  • Open Access.

STIMULUS-MDS2 design and rationale: a phase III trial with the anti-TIM-3 sabatolimab (MBG453)+azacitidine in higher risk MDS and CMML-2.

Zeidan AM; (...); Santini V

Article. 10.2217/fon-2022-1237. 2023

  • Open Access.

The impact of GVHD on outcomes after adult single cord blood transplantation in European and Japanese populations.

Kanda, Junya; (...); Gluckman, Eliane

Article. 10.1038/s41409-021-01479-4. 2022

  • Open Access.

The Impact of GVHD on Outcomes After Adult Single Cord Blood Transplantation In European And Japanese Populations: The EUROCORD/ALWP EBMT And JSHCT/JDCHCT Collaborative Study

Kanda, J; (...); Gluckman, E

Meeting Abstract. 2021


Towarda more patient-centered drug development process in clinical trials for patients with myelodysplastic syndromes/neoplasms (MDS): Practical considerations from the International Consortium for MDS (icMDS).

Efficace, Fabio; (...); Zeidan, Amer M

Article. 10.1002/hem3.69. 2024

  • Open Access.

Transfusion Burden in Allogeneic Hematopoietic Stem Cell Transplantation over Time: Experience from a Single Institution.

Solves, Pilar; (...); Sanz, Jaime

Article. 10.3390/jcm12103467. 2023

  • Open Access.

Treatment Patterns and Overall Survival in Patients with Intermediate-Risk MDS: A Retrospective Analysis in the Spanish MDS Registry

Diez-Campelo, Maria; (...); Valcarcel, David

Meeting Abstract. 10.1182/blood-2021-146019. 2021

  • Open Access.

UBA1 Mutations Identify a Rare but Distinct Subtype of Myelodysplastic Syndromes

Sirenko, Maria; (...); Papaemmanuil, Elli

Meeting Abstract. 10.1182/blood-2023-182949. 2023

  • Open Access.

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