Estudio multicéntrico, aleatorizado y abierto de romiplostim más dexametasona frente a dexametasona en pacientes con trombocitopenia inmune primaria recién diagnosticada.

Datos básicos

Protocolo:: RODEX
EUDRACT:: 2021-006970-22
NCT:
Centro:: HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Año de incio:: 2022
Año de finalización:

ENSAYO CLÍNICO

Objetivos del proyecto

Objetivo Principal: Evaluar la superioridad de romiplostim más dexametasona frente a dexametasona sola después de 6 meses (=180 días) desde el cese del tratamiento en pacientes con trombocitopenia inmune primaria (PTI) reciente, en términos de respuesta sostenida sin ningún tratamiento para la PTI (6mSROT-50) y sin hemorragias de grado 2 o más de la OMS. Objetivos Secundarios: Evaluar la proporción de pacientes en ambos brazos que consiguen plaquetas superiores o iguales a 30x109/L (SROT-30) o 50 x109/L (SROT-50) en ausencia de cualquier tratamiento de PTI, incluido cualquier tratamiento de rescate, durante al menos 6 meses consecutivos (=180 días) (6m) o 12 meses consecutivos (12m) desde el cese del tratamiento y sin hemorragias de grado 2 o más de la OMS. Evaluar la proporción de pacientes en ambos brazos con respuesta completa (RC), respuesta (R), respuesta global(RG) y rango objetivo (TR). También con respuesta temprana (RE) y respuesta inicial (RI) Comparar el tiempo hasta la pérdida de respuesta (LoR) en los pacientes que alcanzaron la respuesta en ambos brazos. Comparar la proporción de pacientes que requirieron algún tratamiento de rescate a lo largo del estudio. Comparar la proporción de pacientes con acontecimientos adversos (EA), incluidos los acontecimientos adversos graves (EAG) y los parámetros de seguridad de laboratorio.

Documentos

No hay documentos

Participantes

Silvia García Palomares

Data Manager / Study Coordinator
José Luis Poveda Andrés

Investigador Colaborador
Maria Perez Fernandez

Técnico Apoyo Investigación
Samuel Romero Domínguez

Investigador Colaborador
Isidro Jarque Ramos

Investigador Principal
Eva Dominguez Malfeito

Data Manager / Study Coordinator
Elvira Mora Castera

Investigador Colaborador
Santiago Furio Rodriguez

Investigador Colaborador

Grupos

Hematología y Hemoterapia

Investigador Principal

Javier De La Rubia Comos
Unidad de Descubrimiento de Fármacos (UDF)

Investigador Principal

Leonor Puchades Carrasco
Grupo de Investigación de Farmacia

Investigador Principal

Javier García Pellicer

Financiadores - Promotores

FUNDACIÓN PÚBLICA ANDALUZA PARA LA GESTIÓN DE LA INVESTIGACIÓN EN SALUD DE SEVILLA

Resultados del Ensayo Clínico

Publicaciones en Revistas 85

[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

[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.

Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.09.006. 2024

A multicentre ambispective observational study into the incidence and clinical management of aplastic anaemia in Spain (IMAS study)

Vallejo C; (...); Codesido ML

Article. 10.1007/s00277-023-05602-x. 2024

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

Application of IPSET-thrombosis in 1366 Patients Prospectively Followed From the Spanish Registry of Essential Thrombocythemia.

Alvarez-Larran, Alberto; (...); Pereira, Arturo

Article. 10.1097/HS9.0000000000000936. 2023

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

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano JB; (...); Soto-Ortega I

Article. 10.1016/j.farma.2023.01.003. 2023

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada

Article. 10.1016/j.farma.2023.04.002. 2023

Chronic liver disease-associated severe thrombocytopenia in Spain: Results from a retrospective study using machine learning and natural language processing.

Calleja-Panero, Jose Luis; (...); Gonzalez Calvo, Jose

Article. 10.1016/j.gastrohep.2023.05.010. 2023

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

Design and Validation of a Custom Next-Generation Sequencing Panel in Pediatric Acute Lymphoblastic Leukemia.

Gil, Jose Vicente; (...); Barragan, Eva

Article. 10.3390/ijms24054440. 2023

Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.

Abad, Maria Reyes; (...); Gil, Alicia

Article. 10.33393/grhta.2024.3041. 2024

Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis

Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther

Article. 10.1002/jvc2.275. 2024

Editorial: Infectious diseases and hematology: diagnosis and management

Gonzalez-Lopez, Tomas Jose; (...); Di Micco, Pierpaolo

Editorial Material. 10.3389/fmed.2024.1385874. 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

ELTROMBOPAG ADDED TO STANDARD IST IS SUPERIOR TO IST ALONE AS FRONT-LINE TREATMENT FOR SEVERE APLASTIC ANEMIA: FINAL 2-YEAR ANALYSIS OF EBMT-SAAWP RACE STUDY

Risitano, Antonio Maria; (...); de Latour, Regis Peffault

Meeting Abstract. 2024

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

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

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

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

Final Analysis of the Phase 2 ELM-2 Study: Odronextamab in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)

Ayyappan, Sabarish; (...); Prince, H. Miles

Meeting Abstract. 10.1182/blood-2023-179818. 2023

Fostamatinib effectiveness and safety for immune thrombocytopenia in clinical practice.

Gonzalez-Lopez, Tomas Jose; (...); Garcia-Donas Gabaldon, Gloria

Article. 10.1182/blood.2024024250. 2024

Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.

Plaza J; (...); Moret-Tatay I

Article. 10.3390/ijms25073717. 2024

Geriatric assessment in hematology scale predicts treatment tolerability in older patients diagnosed with hematological malignancies: The RETROGAH study.

de la Rubia J; (...); Bonanad, Santiago

Article. 10.1016/j.jgo.2022.10.016. 2022

GERMLINE PREDISPOSITION TO MYELOID MALIGNANCIES IN A CONSECUTIVE COHORT OF 183 PATIENTS

Santiago, M.; (...); Cervera-Zamora, J.

Meeting Abstract. 10.1016/j.leukres.2023.107247. 2023

Health-Related Quality of Life and Symptoms in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Treated with Odronextamab Monotherapy in the Phase 2 ELM-2 Study

Iskierka-Jazdzewska, Elzbieta; (...); Ivanescu, Cristina

Meeting Abstract. 10.1182/blood-2023-180743. 2023

How can artificial intelligence optimize value-based contracting?

Poveda, Jose Luis; (...); Medrano, Ignacio H.

Letter. 10.1186/s40545-022-00475-3. 2022

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

IFISTRATEGY: Spanish National Survey of Invasive Fungal Infection in Hemato-Oncologic Patients.

Vallejo, Carlos; (...); Peman, Javier

Article. 10.3390/jof9060628. 2023

Immunoparesis recovery in newly diagnosed transplant ineligible multiple myeloma patients, an independent prognostic factor that complements minimal residual disease.

Lakhwani S; (...); Hernández MT

Article. 10.1007/s00277-024-06031-0. 2024

Immunoparesis Recovery in Transplant-Ineligible Newly Diagnosis Multiple Myeloma Patients: An Independent Prognosis Factor That Could Complement Prognostic Value of Minimal Residual Disease

Lakhwani, Sunil; (...); Hernandez, Miguel-Teodoro

Meeting Abstract. 10.1182/blood-2022-166826. 2022

Immunotherapy May be Preferable to Chemotherapy As Second-Line Treatment for POD24 Follicular Lymphoma (FL) Patients

Serna, Angel; (...); Abrisqueta, Pau

Meeting Abstract. 10.1182/blood-2024-207871. 2024

Impact of pre- and/or post-autologous stem cell transplantation exposure to brentuximab vedotin on survival outcomes in patients with high-risk Hodgkin lymphoma.

Martinez, Carmen; (...); Garcia-Sanz, Ramon

Article. 10.1007/s00277-022-05011-6. 2022

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

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

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

Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.

Pozo-Rosich P; (...); Irimia P

Article. 10.1186/s10194-024-01747-w. 2024

Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.

Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula

Article. 10.3390/antibiotics13080706. 2024

Lenalidomide and dexamethasone maintenance with or without ixazomib, tailored by residual disease status in myeloma.

Rosinol, Laura; (...); Blade, Joan

Article. 10.1182/blood.2022019531. 2023

Lenalidomide in combination with R-ESHAP in patients with relapsed or refractory diffuse large B-cell lymphoma: A phase 2 study from GELTAMO.

Martin Garcia-Sancho, A.; (...); Caballero, D.

Article. 10.1111/bjh.18989. 2023

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

Novel Agents May be Preferable to Standard Chemotherapy in Second-Line for Early Relapsing Follicular Lymphoma (FL) Patients

Serna, Angel; (...); Abrisqueta Costa, Pau

Meeting Abstract. 10.1182/blood-2023-186019. 2023

Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus

Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis

Article. 10.1097/MD.0000000000032208. 2022

Odronextamab in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL): Results from a Prespecified Analysis of the Pivotal Phase II Study ELM-2

Kim, Won-Seog; (...); Walewski, Jan

Meeting Abstract. 10.1182/blood-2022-158406. 2022

ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.

Poveda JL; (...); Badia X

Article. 10.1186/s13023-022-02610-4. 2023

Ofatumumab as part of reduced intensity conditioning in high risk B-cell lymphoma patients: final long-term analysis from a prospective multicenter Phase-II Trial

Cabrero M; (...); Caballero D

Article. 10.1038/s41409-023-02171-5. 2024

Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Review. 10.3390/biology12091159. 2023

OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT

Flores-Moreno, S.; (...); Gil, A.

Meeting Abstract. 2024

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

Outcomes of Patients with Hodgkin Lymphoma Receiving Brentuximab Vedotin (BV) As Maintenance Therapy after ASCT According to Previous Exposure to BV. a Retrospective Analysis of the EBMT Lymphoma Working Party in Collaboration with Geltamo, FIL, Lysarc, and Turkish Lymphoma Group

Munoz, Maria Carmen Martinez; (...); Balari, Anna Sureda

Meeting Abstract. 10.1182/blood-2024-205007. 2024

Paradoxical Findings in Patients with Paroxysmal Nocturnal Hemoglobinuria Treated with C5 Inhibitors: Suboptimal Disease Control Perceived As Satisfactory

Gaya, Anna; (...); Vallejo, Carlos

Meeting Abstract. 10.1182/blood-2023-185939. 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

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

Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services

Company Albir MJ, Poveda Andrés JL, Edo Solsona MD

Article. 10.1016/j.farma.2023.06.0131130. 2024

Primary and secondary immune thrombocytopenia (ITP): Time for a rethink.

Gonzalez-Lopez, Tomas Jose; (...); Fernandez-Fuertes, Fernando

Article. 10.1016/j.blre.2023.101112. 2023

Prognostic Factors and Treatment Strategy in Patients with Hodgkin Lymphoma and HIV Infection Treated with ABVD and CART: A Retrospective Study from Spanish Group Geltamo

Huguet, Maria; (...); Navarro, Jose-Tomas

Meeting Abstract. 10.1182/blood-2023-189756. 2023

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

Real-life clinical practice in Spain in the setting of new drug availability for ITP treatment. A Delphi-based Spanish expert panel consensus.

Gonzalez-Lopez, Tomas Jose; (...); Jarque, Isidro

Article. 10.1080/09537104.2024.2336104. 2024

Recommendations for the Clinical Approach to Immune Thrombocytopenia: Spanish ITP Working Group (GEPTI).

Mingot-Castellano, Maria Eva; (...); Pascual-Izquierdo, Cristina

Article. 10.3390/jcm12206422. 2023

Recovery of Uninvolved Heavy/Light Chain Pair Immunoparesis during Maintenance Is an Independent Prognostic Factor for Multiple Myeloma and Could Complement Prognosis Value of Minimal Residual Disease

Lakhwani, Sunil; (...); Hernandez, Miguel-Teodoro

Meeting Abstract. 10.1182/blood-2022-167247. 2022

Recovery of uninvolved heavy/light chain pair immunoparesis in newly diagnosed transplant-eligible myeloma patients complements the prognostic value of minimal residual disease detection.

Lakhwani S; (...); Hernández MT

Article. 10.3324/haematol.2023.284154. 2024

Supervised Machine Learning Improves Risk Stratification in Newly Diagnosed Myelodysplastic Syndromes: An Analysis of the Spanish Group of Myelodysplastic Syndromes

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

Meeting Abstract. 10.1182/blood-2022-159429. 2022

Sustained Recovery of Uninvolved Heavy/Light Chain Pair Immunoparesis during Maintenance Discriminates Patients with Sustained Negative Minimal Residual Disease

Lakhwani, Sunil; (...); Teodoro Hernandez Garcia, Miguel

Meeting Abstract. 10.1182/blood-2023-179452. 2023

The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).

Badia, Xavier; (...); Valles, Joan-Antoni

Article. 10.1186/s13023-024-03324-5. 2024

Thrombogenesis Mechanisms of High Doses of Ponatinib in Patients with Chronic Myeloid Leukemia (CML) Compared to Tyrosine Kinase Inhibitors

Aguila, Sonia; (...); Ferrer Marin, Francisca

Meeting Abstract. 10.1182/blood-2022-163070. 2022

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

Toxicity of Asciminib in Real Clinical Practice: Analysis of Side Effects and Cross-Toxicity with Tyrosine Kinase Inhibitors.

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

Article. 10.3390/cancers15041045. 2023

Toxicity of Asciminib in Real Clinical Practice; Analysis of Side Effects and Cross-Intolerance with Tyrosine Kinase Inhibitors

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

Meeting Abstract. 10.1182/blood-2022-167453. 2022

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

TP53 Allelic State in Myelodysplastic Syndromes with 5q Deletion

Montoro Gomez, Maria Julia; (...); Valcarcel, David

Meeting Abstract. 10.1182/blood-2022-165257. 2022

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

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

VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA

Poveda, J. L.; (...); Lizan, L.

Meeting Abstract. 2023

Estudio multicéntrico, aleatorizado y abierto de romiplostim más dexametasona frente a dexametasona en pacientes con trombocitopenia inmune primaria recién diagnosticada.

Datos básicos

Objetivos del proyecto

Documentos

Participantes

Grupos

Financiadores - Promotores

Resultados del Ensayo Clínico

Campos de Estudio

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