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- Projectes i Estudis Clínics
- Reducción en los niveles de metotrexato (MTX) después del tratamiento con dosis reducidas de glucarpidasa en pacientes con linfoma B difuso de célula grande (LBDCG) con riesgo de afectación del sistema nervioso central (SNC) que reciben ciclos de HDMTX: estudio multicéntrico, abierto, intervencionista, no aleatorizado, fase 2, piloto.
Reducción en los niveles de metotrexato (MTX) después del tratamiento con dosis reducidas de glucarpidasa en pacientes con linfoma B difuso de célula grande (LBDCG) con riesgo de afectación del sistema nervioso central (SNC) que reciben ciclos de HDMTX: estudio multicéntrico, abierto, intervencionista, no aleatorizado, fase 2, piloto.
Dades bàsiques
- Protocol:
- MDA-BTG-2020-01
- EURDRACT:
- 2020-004450-30
- NCT:
- Centre:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Any inici:
- 2022
- Any de finalització:
- 2023
Objectius del projecte
Objetivo Principal: 1. Describir la reducción de los niveles séricos de MTX después de la administración sistemática de Glucarpidasa 12 horas después del inicio de la infusión de HDMTX en pacientes con LDCBG con alto riesgo de afectación del SNC, que reciben múltiples ciclos de HDMTX. Objetivos Secundarios: 1. Analizar el efecto profiláctico de la Glucarpidasa administrada después de 12 horas de administración de dosis altas de MTX (HDMTX) sobre la incidencia, gravedad y duración de la toxicidad relacionada con MTX (toxicidad renal, mucositis, toxicidad hepática, neutropenia, trombocitopenia). 2. Evaluar la incidencia de recidivas en SNC durante un año. 3. Evaluar la duración de la estancia hospitalaria (LOS) durante la terapia HDMTX. 4. Analizar la aparición de anticuerpos frente a la Glucarpidasa 5. Analizar la aparición de anticuerpos neutralizantes frente a Glucarpidasa
Documents
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Grups d'Investigació
Finançadors - Promotors
Resultats de l'Assaig Clínic
A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.
Zozaya, Neboa; (...); Verde, Luis
Article. 10.1017/S0266462322000459. 2022
A simple score to predict early severe infections in patients with newly diagnosed multiple myeloma
Encinas, Cristina; (...); Martinez-Lopez, Joaquin
Article. 10.1038/s41408-022-00652-2. 2022
Accuracy and prognostic impact of FDG PET/CT and biopsyin bone marrow assessment of follicular lymphomaat diagnosis: A Nation-Wide cohort study.
Rodenas-Quinonero, Isabel; (...); Ortuno, Francisco Jose
Article. 10.1002/cam4.5424. 2022
Artificial Intelligence on FDG PET Images Identifies Mild Cognitive Impairment Patients with Neurodegenerative Disease.
Prats-Climent, Joan; (...); Marti-Bonmati, Luis
Article. 10.1007/s10916-022-01836-w. 2022
Autologous stem cell transplantation as consolidation of first-line chemotherapy in patients with peripheral T-cell lymphoma: a multicenter GELTAMO/FIL study.
García-Sancho AM; (...); Caballero D
Article. 10.3324/haematol.2021.279426. 2022
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
Cytokine response as a biomarker for early diagnosis and outcome prediction of stem cell transplant recipients and acute leukemia patients with invasive aspergillosis.
Puerta-Alcalde, Pedro; (...); Garcia-Vidal, Carolina
Article. 10.1093/mmy/myac038. 2022
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
Efficacy and Safety of Treatment Venetoclax Monotherapy or Combined with Rituximab in Patients with Relapsed/ Refractory Chronic Lymphocytic Leukemia (CLL) in the Real-World Setting in Spain: An Update of the Venares Study
Ferra, Christelle; (...); Baltasar, Patricia
Meeting Abstract. 10.1182/blood-2022-162186. 2022
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
Healthcare Resource Utilization among Patients between 60-75 Years with Secondary Acute Myeloid Leukemia Receiving Intensive Chemotherapy Induction: A Spanish Retrospective Observational Study
Solana-Altabella, Antonio; (...); Martinez-Cuadron, David
Article. 10.3390/cancers14081921. 2022
High incidence of pulmonary thromboembolism in hospitalized SARS-CoV-2 infected patients despite thrombo-prophylaxis.
El-Qutob D; (...); Carrera-Hueso FJ
Article. 10.1016/j.hrtlng.2022.02.003. 2022
Hospital pharmacy initiatives for improving the management of patients with congenital coagulopathies
Bruno Montoro-Ronsano, Jose; (...); Alberto Vella, Vincenzo
Article. 10.7399/fh.11729. 2022
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
Immunobiology of cytomegalovirus infection in patients with haematological malignancies undergoing treatment with small molecule inhibitors.
de la Asuncion Carlos, Solano; (...); Navarro, David
Letter. 10.1111/bjh.18655. 2023
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
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
Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.
Vázquez Polo A; (...); Vázquez Costa JF
Article. 10.20960/nh.03946. 2022
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
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
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
Prognostic Value of Serum Paraprotein Response Kinetics in Patients With Newly Diagnosed Multiple Myeloma.
Tamariz-Amador, Luis-Esteban; (...); Troconiz, Inaki F.
Article. 10.1016/j.clml.2022.04.024. 2022
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
SMPTall man lettering application in medication information systems as a quality and safety strategy in hospital organization
Iglesias Gomez, Ruben; (...); Poveda Andres, Jose Luis
Article. 10.1111/jcpt.13703. 2022
Systematic Review of Pharmacogenetics of ABC and SLC Transporter Genes in Acute Myeloid Leukemia
Megías-Vericat JE; (...); Montesinos P
Review. 10.3390/pharmaceutics14040878. 2022
The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity
Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar
Article. 10.1007/s00431-022-04628-z. 2022
The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.
Gil-Nagel A; (...); Gil A
Article. 10.1016/j.yebeh.2022.108711. 2022
vol2Brain: A New Online Pipeline for Whole Brain MRI Analysis
Manjón JV; (...); Coupé P
Article. 10.3389/fninf.2022.862805. 2022