Portal de investigación
Estudio multicéntrico, aleatorizado y abierto de romiplostim más dexametasona frente a dexametasona en pacientes con trombocitopenia inmune primaria recién diagnosticada.
Datos básicos
- Código:
- RODEX
- Protocolo:
- RODEX
- EUDRACT:
- 2021-006970-22
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Dotación:
- Año de incio:
- 2022
- Año de finalización:
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
Grupos
Financiadores - Promotores
Resultados del Ensayo Clínico
[Translated article] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence
Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda
Editorial Material. 10.1016/j.farma.2024.08.009. 2024
[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Andrés JLP, Solsona MDE
Article. 10.1016/j.farma.2023.10.004. 2024
[Translated article] New challenges in advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2024.05.001. 2024
[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
Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).
Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
Avatrombopag in immune thrombocytopenia: A real-world study of the Spanish ITP Group (GEPTI).
Pascual-Izquierdo C; (...); Mingot-Castellano ME
Article. 10.1002/ajh.27498. 2024
CLINICAL AND MOLECULAR CHARACTERIZATION OF PATIENTS WITH THERAPY RELATED MYELOID NEOPLASMS
Calvete, O.; (...); Sole, F.
Meeting Abstract. 10.1016/j.leukres.2023.107176. 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
COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN
Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.
Meeting Abstract. 2024
Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.
Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL
Editorial Material. 10.1016/j.farma.2024.08.001. 2024
Cytogenetic Assessment and Risk Stratification in Myelofibrosis with Optical Genome Mapping.
Diaz-Gonzalez, Alvaro; (...); Such, Esperanza
Article. 10.3390/cancers15113039. 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
-
-
-
PlumX Metrics
- Citations
- Citation Indexes: 10
- Policy Citations: 2
- Captures
- Readers: 26
- Mentions
- News Mentions: 1
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
Machine Learning Improves Risk Stratification in Myelofibrosis: An Analysis of the Spanish Registry of Myelofibrosis
Mosquera Orgueira, Adrian; (...); Hernandez Boluda, Juan Carlos
Meeting Abstract. 10.1182/blood-2022-158669. 2022
Machine Learning Improves Risk Stratification in Myelofibrosis: An Analysis of the Spanish Registry of Myelofibrosis.
Mosquera-Orgueira A; (...); Hernández-Boluda JC
Article. 10.1097/HS9.0000000000000818. 2023
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
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
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.
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