1. Inicio
  2. Proyectos y Estudios
  3. “A Multi-phase, Dose-Escalation followed by an Open-label, Randomized, Crossover Study of Oral ASTX030 (Cedazuridine and Azacitidine Given in Combination) Versus Subcutaneous Azacitidine in Subjects with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)”.

“A Multi-phase, Dose-Escalation followed by an Open-label, Randomized, Crossover Study of Oral ASTX030 (Cedazuridine and Azacitidine Given in Combination) Versus Subcutaneous Azacitidine in Subjects with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)”.

Datos básicos

Protocolo:
ASTX030-01
EUDRACT:
2022-502898-42-00
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Año de incio:
2024
Año de finalización:
ENSAYO CLÍNICO

Documentos

  • No hay documentos

Participantes

Grupos

Financiadores - Promotores

ASTEX PHARMACEUTICALS INC

Resultados del Ensayo Clínico

[Translated article] Knowledge of biological therapy in patients with immune-mediated diseases. BIOINFO study.

Segui-Solanes, Carlos; (...); Borras-Blasco, Joaquin

Article. 10.1016/j.farma.2024.08.002. 2024

  • Open Access.

[Translated article] New challenges in advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2024.05.001. 2024

  • Open Access.

[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.

Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.12.007. 2025


AML typical mutations (CEBPA, FLT3, NPM1) identify a high-risk chronic myelomonocytic leukemia independent of CPSS molecular.

Castano-Diez, Sandra; (...); Diaz-Beya, Marina

Article. 10.1182/bloodadvances.2024013648. 2025


Benefits of physical activity self-monitoring in patients with haemophilia: a prospective study with one-year follow-up.

Pérez-Alenda S; (...); Núñez-Cortés R

Article. 10.1111/hae.14988. 2024

  • 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 and Molecular Characterization of Triple-Negative Essential Thrombocythemia: Data from the Prospective Spanish Registry of Essential Thrombocythemia

Gil-Manso, Rodrigo; (...); Alvarez-Larran, Alberto

Meeting Abstract. 10.1182/blood-2023-188875. 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


Cost-effectiveness and cost-utility analysis of haemate-P versus other von willebrand disease treatments in Spain.

Megias-Vericat, Juan E; (...); Yan, Songkai

Article. 10.1080/13696998.2025.2474886. 2025


Chronic Myelomonocytic Leukemia ( CMML) with AML Typical Mutations ( NPM1, FLT3 or CEBPA) Identify a High-Risk CMML Group Independent of Molecular-Cpss

Castano-Diez, Panelsandra; (...); Diaz-Beya, Marina

Meeting Abstract. 10.1182/blood-2023-173311. 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


Deletion of exons 45 to 55 in the DMD gene: from the therapeutic perspective to the in vitro model

Poyatos-Garcia, Javier; (...); Vilchez, Juan J

Article. 10.1186/s13395-024-00353-3. 2024

  • Open Access.

Development and testing of a mobile app for systematic collection of patient-reported outcomes (PROs) in patients with hemophilia.

Megias-Vericat, J E; (...); Poveda Andres, J L

Letter. 10.1016/j.thromres.2024.109122. 2024


Efficacy of Consolidation Therapy with Ponatinib 15mg on Treatment-Free Remission Rate in Patients with Chronic Myeloid Leukemia. Results of the Ponazero Trial

Perez-Lamas, Lucia; (...); Garcia Gutierrez, Valentin

Meeting Abstract. 10.1182/blood-2023-184989. 2023

  • Open Access.

Endothelial Biomarkers Are Superior to Classic Inflammatory Biomarkers in Community-Acquired Pneumonia.

González-Jiménez P; (...); Méndez R

Article. 10.3390/biomedicines12102413. 2024

  • 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


Expert consensus on the use of systemic glucocorticoids for managing eosinophil-related diseases

del Pozo, Victoria; (...); Rua-Figueroa, Inigo

Review. 10.3389/fimmu.2023.1310211. 2024

  • 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


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.

Identification of patient-reported outcomes measures (PROMs) and patient-reported experiences measures (PREMs) in Gaucher disease in Spain.

Giraldo P; (...); Morales-Conejo M

Article. 10.1016/j.medcli.2024.06.006. 2024

  • 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


Impact of somatic gene mutations on the risk of thrombosis in myelofibrosis.

Pastor-Galan, Irene; (...); Hernandez-Boluda, Juan Carlos

Article. 10.1038/s41375-024-02389-2. 2024


Initial and Residual Cardiovascular Damage Remaining at Day 30 in Community-acquired Pneumonia

Ocana, R. Mendez; (...); Menendez, R.

Meeting Abstract. https://doi.org/10.1164/ajrccm-conference.2024.209.1_MeetingAbstracts.A6241. 2024

  • Open Access.

Integrating AIPSS-MF and molecular predictors: A comparative analysis of prognostic models for myelofibrosis

Mosquera-Orgueira, Adrian; (...); Hernandez-Boluda, Juan C.

Letter. 10.1002/hem3.60. 2024

  • 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.

Machine Learning Improves Risk Stratification in Myelodysplastic Neoplasms: An Analysis of the Spanish Group of Myelodysplastic Syndromes.

Mosquera Orgueira, Adrian; (...); Valcarcel, David

Article. 10.1097/HS9.0000000000000961. 2023

  • 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.

Mental, emotional and social dimensions of quality of life and their relationship with physical and functional status in adults with haemophilia.

Rodríguez MA; (...); Chimeno-Hernández A

Article. 10.1016/j.thromres.2024.109181. 2024

  • 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


New challenges of advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2023.11.008. 2024

  • 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.

Outcomes of Chronic Myeloid Leukemia Patients after Therapeutic Failure to Asciminib, a Multicenter Observational Study

Perez-Lamas, Lucia; (...); Gutierrez, Valentin Garcia

Meeting Abstract. 10.1182/blood-2023-187412. 2023


Outcomes of chronic myeloid leukemia patients after therapeutic failure to conventional tyrosine kinase inhibitors and asciminib

Perez-Lamas, Lucia; (...); Garcia-Gutierrez, Valentin

Article. 10.1007/s00277-024-05906-6. 2024

  • 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


Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.

Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis

Article. 10.3390/ijms26041760. 2025

  • Open Access.

Predictive Value of First Amniotic Sac IL-6 and Maternal Blood CRP for Emergency Cerclage Success in Twin Pregnancies.

Diago-Munoz, Diana Maria; (...); Diago-Almela, Vicente Jose

Article. 10.3390/jpm15010037. 2025


Preliminary Safety and Efficacy of Luspatercept Initiated at Maximum Approved Dose in Patients with Transfusion Dependent Anemia Due to Very Low, Low and Intermediate Risk MDS with Ring Sideroblasts: First Results of the Lusplus Trial

Goetze, Katharina S. S.; (...); Platzbecker, Uwe

Meeting Abstract. 2024


Real life data: follow-up assessment on Spanish Gaucher disease patients treated with eliglustat. TRAZELGA project.

Serrano-Gonzalo, Irene; (...); Giraldo, Pilar

Article. 10.1186/s13023-023-02939-4. 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.

Total body irradiation versus thiotepa/busulfan-based conditioning regimens for myeloablative allogeneic stem cell transplantation in adults with acute lymphoblastic leukemia.

Mora E; (...); Sanz J

Article. 10.1038/s41409-024-02298-z. 2024


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.

Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.

Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis

Article. 10.1136/ejhpharm-2024-004184. 2024


Transfusion independence after lenalidomide discontinuation in patients with del(5q) myelodysplastic neoplasm: a HARMONY Alliance study.

Crisà E; (...); Santini V

Article. 10.1038/s41375-024-02360-1. 2024

  • 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.

Validation of the Artificial Intelligence Prognostic Scoring System for Myelodysplastic Syndromes in chronic myelomonocytic leukaemia: A novel approach for improved risk stratification.

Mosquera Orgueira, Adrian; (...); Valcarcel, David

Article. 10.1111/bjh.19341. 2024

  • Open Access.

Campos de Estudio

Compartir