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Projectes i Estudis Clínics
LOGGIC/FIREFLY-2: Ensayo en fase III, aleatorizado, internacional y multicéntrico de DAY101 en monoterapia frente a la quimioterapia estándar en pacientes con glioma pediátrico de bajo grado que presentan una alteración de RAF activadora que requiere tratamiento sistémico de primera línea.

LOGGIC/FIREFLY-2: Ensayo en fase III, aleatorizado, internacional y multicéntrico de DAY101 en monoterapia frente a la quimioterapia estándar en pacientes con glioma pediátrico de bajo grado que presentan una alteración de RAF activadora que requiere tratamiento sistémico de primera línea.

Dades bàsiques

Protocol:: DAY101-002
EURDRACT:: 2022-001363-27
NCT:
Centre:: HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Any inici:: 2023
Any de finalització:

ENSAYO CLÍNICO

Objectius del projecte

Objetivo Principal: Comparar la tasa de respuesta objetiva (TRO) evaluada según los criterios RANO por el comité de revisión independiente (CRI) de DAY101 en monoterapia frente a la quimioterapia estándar en pacientes con glioma pediátrico de bajo grado que presentan una alteración de RAF activadora que requiere tratamiento sistémico de primera línea. Objetivos Secundarios: OBJETIVOS SECUNDARIOS CLAVE: - Comparar la supervivencia sin progresión (SSP) con DAY101 en monoterapia frente a la quimioterapia estándar, de acuerdo con el CRI conforme a los criterios RANO. - Comparar la duración de la respuesta (DR) con DAY101 en monoterapia frente a la quimioterapia estándar, de acuerdo con el CRI conforme a los criterios RANO - Comparar la supervivencia global (SG) con DAY101 en monoterapia frente a la quimioterapia estándar.

Documents

No hi ha documents

Participants

Catalina Montoya Tamayo

Investigador Colaborador
Alejandro Montoya Filardi

Investigador Colaborador
Miguel Ángel Navarro Mira

Investigador Colaborador
Vanessa Segura Caballer

Data Manager / Study Coordinator
Rafael Botella Estrada

Investigador Colaborador
Ana Cano Sánchez

Investigador Colaborador
Eladio Ruiz González

Investigador Colaborador
José Luis Poveda Andrés

Investigador Colaborador
Desiree Ramal Pons

Investigador Principal
Margarita Mercedes Llavador Ros

Investigador Colaborador
Verónica Massó López

Data Manager / Study Coordinator
Pablo Miranda Lloret

Investigador Colaborador
Adela Cañete Nieto

Investigador Principal
Blanca Martínez De Las Heras

Data Manager / Study Coordinator
Honorio Barranco González

Investigador Colaborador
Nuria Rausell Fontestad

Investigador Colaborador
Sonia Gines Cardenas

Investigador Colaborador
Africa Almendros Riaza

Investigador Colaborador
Basilio Mateo Quiñonero

Investigador Colaborador
Concepción Almor Palacios

Investigador Colaborador
Oussama Bardouz Gouguasse

Investigador Colaborador
Ana Rodrigo Hernández

Investigador Colaborador
Maria Del Pilar Morcillo Toledo

Investigador Colaborador
Cristina Ferrando Juan

Investigador Colaborador
Clara Calderón Gallego

Investigador Colaborador
Mireia Mascarell Vidal

Investigador Colaborador

Veure tots els Investigadors

Grups d'Investigació

Investigación Clínica y Traslacional en Cáncer

Leader

José Gómez Codina
Regeneración y Trasplante Cardíaco

Leader

Pilar Sepúlveda Sanchis
Dermatología y Regeneración Tisular

Leader

Rafael Botella Estrada
Unidad de Descubrimiento de Fármacos (UDF)

Investigador Principal

Leonor Puchades Carrasco
Grupo de Investigación de Farmacia

Investigador Principal

Javier García Pellicer

Finançadors - Promotors

Day One Biopharmaceuticals, Inc. (Day One)

Resultats de l'Assaig Clínic

Publicacions en Revistes 129

"Phytophotodermatitis as a clinical problem and as a therapeutic option: case report and review of the literature".

Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael

Article. 10.1016/j.pdpdt.2023.103304. 2023

[[Tranaslated article]]Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.

López DF; (...); Ortiz-Romero, P. L.

Article. 10.1016/j.ad.2022.11.013. 2023

[[Translated article]]Drug Survival in Cyclosporine Treatment for Moderate to Severe Atopic Dermatitis: Analysis of the Spanish Atopic Dermatitis Registry (BIOBADATOP).

Couselo-Rodríguez C; (...); Flórez Á

Article. 10.1016/j.ad.2023.07.028. 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 Case of Localised Immediate Hypersensitivity Reaction to Bimekizumab.

Lasheras-Perez, Miguel Antonio; (...); Ibanez-Echevarria, Ethel

Article. 10.1111/cod.14774. 2025

A Gadolinium(III) Complex Based on Pyridoxine Molecule with Single-Ion Magnet and Magnetic Resonance Imaging Properties.

Orts-Arroyo, Marta; (...); Martinez-Lillo, Jose

Article. 10.3390/ijms25042112. 2024

Alectinib in pediatric patients with solid or CNS tumors harboring ALK-fusions: Emerging pharmacokinetic data from the iMATRIX alectinib phase I/II open-label, multi-center study

Doz, Francois; (...); Gajjar, Amar J.

Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.3098. 2024

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

ASSESSMENT OF A NOVEL READY-TO-USE TEMOZOLOMIDE ORAL SUSPENSION IN CHILDREN WITH SOLID TUMORS: RESULTS OF TEMOKIDS, A POPULATION PHARMACOKINETIC, ACCEPTABILITY AND SAFETY PHASE-1 STUDY

Abbou, Samuel; (...); Metayer, Lucy

Meeting Abstract. 2023

Barriers and facilitators to the implementation of a new European eHealth solution (SurPass v2.0): the PanCareSurPass Open Space study.

de Beijer IAE; (...); Pluijm SMF

Article. 10.1007/s11764-023-01498-8. 2023

BIOBADATOP Spanish Atopic Dermatitis Registry: Description and Early Findings.

Munera-Campos M; (...); Carrascosa JM

Article. 10.1016/j.ad.2023.03.001. 2023

Cancer is not a risk factor for severe COVID-19 in children, except in patients with recent allogeneic hematopoietic stem cell transplantation or comorbidities.

Velasco Puyó P; (...); Astigarraga I

Article. 10.1002/pbc.31120. 2024

Casal necklace.

Mansilla-Polo, Miguel, Martin-Torregrosa, Daniel, Botella-Estrada, Rafael

Article. 10.1016/j.medcli.2023.03.035. 2023

Clinicopathological characteristics of cutaneous and mucocutaneous leishmaniasis in patients treated with TNF-alpha inhibitors.

Palacios-Diaz, Rodolfo David; (...); Botella-Estrada, Rafael

Article. 10.1111/ddg.15007. 2023

Comparison of different agents and doses of anti-vascular endothelial growth factors (aflibercept, bevacizumab, conbercept, ranibizumab) versus laser for retinopathy of prematurity: A network meta-analysis.

Ortiz-Seller, Amparo; (...); Ortiz, Jose L.

Article. 10.1016/j.survophthal.2024.02.005. 2024

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

Childhood and Adolescent Central Nervous System Tumours in Spain: Incidence and Survival over 20 Years: A Historical Baseline for Current Assessment.

Chirlaque MD; (...); The Spanish Childhood Cancer Epidemiology Working Group

Article. 10.3390/cancers15245889. 2023

Childhood-Onset Non-Infectious Uveitis in the "Biologic Era". Results From Spanish Multicenter Multidisciplinary Real-World Clinical Settings.

Mesa-Del-Castillo P; (...); Sánchez Sevila JL

Article. 10.1080/09273948.2024.2336609. 2024

Dermatologic Consultations for Patients Hospitalized in Non-Dermatologic Wards: Results of a 384-Patient Cross-Sectional Study From a Tertiary Referral Hospital

Mansilla-Polo, M.; (...); Botella-Estrada, R.

Letter. 10.1016/j.ad.2024.10.030. 2024

Dermatologic consultations for patients hospitalized in non-dermatologic wards: results of a 384-patient cross-sectional study from a tertiary referral hospital.

Mansilla-Polo, M; (...); Botella-Estrada, R

Case Reports. 10.1016/j.ad.2023.11.021. 2023

Dermatological toxicities of talquetamab, a new bispecific antibody: case series and literature review.

Mansilla-Polo M; (...); Botella-Estrada R

Letter. 10.1111/ddg.15502. 2024

Dermatological toxicities of talquetamab, a new bispecificantibody: case series and literature review

Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael

Letter. 10.1111/ddg.15502_g. 2024

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

Development and validation of a model to predict complex Mohs Micrographic Surgery in clinical practice: REGESMOSH scale.

Montero-Vilchez, Trinidad R.; (...); Sanmartin-Jimenez, Onofre

Article. 10.1111/jdv.19056. 2023

Dose tapering of dupilumab in patients with persistently controlled atopic dermatitis: a Spanish multicenter cohort study

Lasheras-Pérez MA; (...); Rodríguez-Serna M

Article. 10.1111/ijd.17030. 2024

Drug Survival in Cyclosporine Treatment for Moderate to Severe Atopic Dermatitis: Analysis of the Spanish Atopic Dermatitis Registry (BIOBADATOP).

Rodriguez, C Couselo; (...); Florez, A.

Article. 10.1016/j.ad.2023.07.014. 2023

ECLIM-SEHOP: how to develop a platform to conduct academic trials for childhood cancer.

Juan-Ribelles A; (...); Fernández-Teijeiro A

Article. 10.1007/s12094-024-03445-0. 2024

Effectiveness and safety of brodalumab in the treatment of plaque, scalp and palmoplantar psoriasis: A multicentre retrospective study in a Spanish population.

Sahuquillo-Torralba, A; (...); Botella-Estrada, R

Article. 10.1111/ajd.14130. 2023

Effectiveness, safety and satisfaction of 1% tirbanibulin ointment in the treatment of actinic keratoses: A prospective study in real clinical practice.

Mansilla-Polo M; (...); Botella-Estrada R

Letter. 10.1111/ajd.14151. 2023

Gastric Bleeding in Stem Cell Transplantation: A Focus on Gastric Vascular Ectasia Under Post-Transplant Cyclophosphamide, Sirolimus, and Mycophenolate Mofetil Prophylaxis.

Eirís J; (...); Sanz J

Article. 10.1016/j.jtct.2024.10.009. 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

Guselkumab, Risankizumab, and Tildrakizumab demonstrate parallel effectiveness and safety in psoriasis treatment: a head-to-head comparative study in real clinical practice.

Mansilla-Polo M; (...); Botella-Estrada R

Article. 10.1016/j.abd.2024.04.004. 2024

Identification of c.104T>G, p.Met35Arg (NM_00314.8) variant in heterozygosity in exon 2 of the PTEN gene as the Causative Factor for Cowden Syndrome: A Medical Case Study.

Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael

Article. 10.1093/ced/llad344. 2023

Imaging biomarkers and radiomics in pediatric oncology: a view from the PRIMAGE (PRedictive In silico Multiscale Analytics to support cancer personalized diaGnosis and prognosis, Empowered by imaging biomarkers) project.

Veiga-Canuto, Diana; (...); Marti-Bonmati, Luis

Article. 10.1007/s00247-023-05770-y. 2023

Independent Validation of a Deep Learning nnU-Net Tool for Neuroblastoma Detection and Segmentation in MR Images

Veiga-Canuto, Diana; (...); Marti-Bonmati, Luis

Article. 10.3390/cancers15051622. 2023

Interim analysis of the multinational, post-authorization safety study (NISSO) to assess the long-term safety of sonidegib in patients with locally advanced basal cell carcinoma

Gutzmer, Ralf; (...); Hauschild, Axel

Article. 10.1186/s12885-024-13101-z. 2024

International benchmarking of childhood cancer survival by tumour stage: First results of the BENCHISTA project

Pritchard-Jones, K.; (...); Gatta, G.

Meeting Abstract. 2024

International benchmarking of stage at diagnosis for six childhood solid tumours (the BENCHISTA project): a population-based, retrospective cohort study.

Botta, Laura; (...); Pritchard-Jones, Kathy

Article. 10.1016/S2352-4642(24)00302-X. 2025

Interparietal nodule in a 49-year-old woman.

Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael

Case Reports. 10.1111/ddg.15398. 2024

Interparietaler Knoten bei einer 49-jährigen Frau

Mansilla-Polo, Miguel; (...); Botella-Estrada, Rafael

Article. 10.1111/ddg.15398_g. 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

IT-Related Barriers and Facilitators to the Implementation of a New European eHealth Solution, the Digital Survivorship Passport (SurPass Version 2.0): Semistructured Digital Survey.

de Beijer, Ismay A E; (...); Chronaki, Catherine

Article. 10.2196/49910. 2024

Klinisch-pathologische Eigenschaften kutaner und mukokutaner Leishmaniose bei mit TNF-a-Inhibitoren behandelten Patienten.

Palacios-Diaz, Rodolfo David; (...); Botella-Estrada, Rafael

Article. 10.1111/ddg.15007_g. 2023

Modeling Cardiotoxicity in Pediatric Oncology Patients Using Patient-Specific iPSC-Derived Cardiomyocytes Reveals Downregulation of Cardioprotective microRNAs.

Reinal, Ignacio; (...); Sepulveda, Pilar

Article. 10.3390/antiox12071378. 2023

Mohs micrographic surgery in immunosuppressed vs immunocompetent patients: Results of a prospective nationwide cohort study (REGESMOHS, Spanish registry of Mohs surgery).

Abril-Pérez C; (...); Botella-Estrada R

Article. 10.1111/jdv.20103. 2024

Myocardial Infarction in Neonates: A Diagnostic and Therapeutic Challenge (vol 2019, 7203407, 2019)

Martinez, Manuel Rodriguez; (...); Carrascosa, Marta Aguar

Correction. 10.1155/2023/9871021. 2023

Narrative Review and Update on Biologic and Small Molecule Drugs for Hidradenitis Suppurativa: An Entity With a Promising Future.

Mansilla-Polo M, Escutia-Muñoz B, Botella-Estrada R

Article. 10.1016/j.ad.2023.08.001. 2023

Narrative Review and Update on Biologic and Small Molecule Drugs for Hidradenitis Suppurativa: An Entity With a Promising Future.

Mansilla-Polo, M., Escutia-Munoz, B., Botella-Estrada, R.

Article. 10.1016/j.ad.2023.05.015. 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

Oral Ruxolitinib could Increase the Aggressiveness of Cutaneous Squamous Cell Carcinomas: A 6-Patient Series

Lasheras-Perez, M. A.; (...); Botella-Estrada, R.

Letter. 10.1016/j.ad.2023.07.035. 2025

Overall survival prediction and risk stratification in patients with neuroblastoma through machine learning in the large multi-institutional PRIMAGE cohort.

Lozano-Montoya, Jose; (...); Alberich-Bayarri, Angel

Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.10054. 2024

Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.

Falkenhain-Lopez, D; (...); Ortiz-Romero, P L

Article. 10.1016/j.ad.2022.11.010. 2023

Prognostic factors for satellitosis or in-transit metastasis in cutaneous squamous cell carcinoma: A multicentric cohort study.

Marti-Marti I; (...); Toll A

Article. 10.1016/j.jaad.2023.02.048. 2023

Regorafenib Plus Vincristine and Irinotecan in Pediatric Patients With Recurrent/Refractory Solid Tumors: An Innovative Therapies for Children With Cancer Study.

Casanova M; (...); Geoerger B

Article. 10.1158/1078-0432.CCR-23-0257. 2023

RE-IRRADIATION FOR PROGRESSIVE DIFFUSE INTRINSIC PONTINE GLIOMA (DIPG): THE SPANISH EXPERIENCE

Panizo, Elena; (...); Lassaletta, Alvaro

Meeting Abstract. 10.1093/neuonc/noae064.116. 2024

Reproducibility Analysis of Radiomic Features on T2-weighted MR Images after Processing and Segmentation Alterations in Neuroblastoma Tumors.

Veiga-Canuto, Diana; (...); Marti-Bonmati, Luis

Article. 10.1148/ryai.230208. 2024

Successful Treatment of Stimulator of Interferon Genes-Associated Vasculopathy of Infantile Onset SAVI Syndrome With Anifrolumab.

Mansilla-Polo M; (...); Botella-Estrada R

Article. 10.1001/jamadermatol.2024.2160. 2024

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

Use of an electrospun bioveil is safe and does not decrease skin graft take on burn wounds: A randomised, controlled clinical trial.

Perez-Del-Caz, Maria Dolores; (...); Perez-Plaza, Aranzazu

Article. 10.1016/j.burns.2025.107427. 2025

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

Vitronectin Levels in the Plasma of Neuroblastoma Patients and Culture Media of 3D Models: A Prognostic Circulating Biomarker?

Lopez-Carrasco, Amparo; (...); Noguera, Rosa

Article. 10.3390/ijms25168733. 2024