Portal de investigación
Estudio en fase III, aleatorizado, abierto y multicéntrico que compara TGuard con ruxolitinib en el tratamiento de pacientes con enfermedad de injerto contra huésped aguda corticorresistente (EICHa-CR) de grado III o IV.
Datos básicos
- Protocolo:
- BMTCTN2002
- EUDRACT:
- 2021-000343-53
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Año de incio:
- 2022
- Año de finalización:
- 2023
Objetivos del proyecto
Objetivo Principal: Evaluar la tasa de respuesta completa (RC) en los participantes conGrados III y IV de la EICHa refractaria a esteroides el Día 28 tras la aleatorización. Objetivos Secundarios: Los objetivos secundarios son: 1.Estimar la supervivencia general los Días 60, 90 y 180. 2.Evaluar la duración de la respuesta completa (DRC). 3.Estimar el tiempo hasta la respuesta completa (RC) desde la aleatorización. 4.Estimar la tasa de respuesta completa (RC) o respuesta parcial (RP) los Días 14, 28 y 56. 5.Describir las proporciones de RC, RP, respuesta mixta (RM), ausencia de respuesta (AR) y progresión de la EICHa los Días 6, 14, 28 y 56. 6.Estimar la incidencia acumulada de mortalidad no por recidiva (MNR) los Días 90 y 180. 7.Estimar la supervivencia sin recidiva el Día 180. 8.Estimar la supervivencia general sin EICH los Días 90 y 180. 9.Estimar la incidencia acumulada de EICH crónica (EICHc) el Día 180. 10.Estimar la incidencia acumulada de recidiva/progresión subyacente el Día 180. 11.Describir la incidencia de infecciones. 12.Describir la incidencia de toxicidades. 13.Evaluar la farmacocinética (FC) de T-Guard. 14.Evaluar la inmunogenicidad de T-Guard.
Documentos
- No hay documentos
Participantes
Financiadores - Promotores
Resultados del Ensayo Clínico
A multicriteria decision analysis (MCDA) applied to three long-term prophylactic treatments for hereditary angioedema in Spain
Zozaya, Neboa; (...); Hidalgo-Vega, Alvaro
Article. 10.33393/grhta.2022.2333. 2022
A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.
Zozaya, Neboa; (...); Verde, Luis
Article. 10.1017/S0266462322000459. 2022
Allogeneic hematopoietic cell transplant for hairy cell leukemia: EBMT experience.
Chihara D; (...); Yakoub-Agha I
Letter. 10.3324/haematol.2022.281754. 2023
Allogeneic Hematopoietic Stem Cell Transplantation Achieves Long-Term Survival in Extranodal Natural Killer/T-Cell Lymphoma: A Retrospective Analysis of the EBMT Lymphoma Working Party
Berning, Philipp; (...); Glass, Bertram
Meeting Abstract. 10.1182/blood-2022-164637. 2022
Allogeneic Hematopoietic Stem Cell Transplantation in Transformed Follicular Lymphoma (tFL): Results of a Retrospective Multicenter Study from GELTAMO/GETH-TC Spanish Groups
Rey-Bua, Beatriz; (...); Martin Garcia-Sancho, Alejandro
Article. 10.3390/cancers14225670. 2022
Allogeneic Stem Cell Transplantation for Patients with Acute Myelogenous Leukemia (AML) in Second Complete Remission (CR2) Transplanted from Unrelated Donors with Post Transplant Cyclophosphamide (PTCy). a Study on Behalf of the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation
Nagler, Arnon; (...); Mohty, Mohamad
Meeting Abstract. 10.1182/blood-2021-144894. 2021
Allogeneic Stem Cell Transplantation in Mantle Cell Lymphoma; Insights into Its Potential Role in the Era of New Immunotherapeutic and Targeted Therapies: The GETH/GELTAMO Experience.
Gutierrez, Antonio; (...); Geltamo
Article. 10.3390/cancers14112673. 2022
Axicabtagene ciloleucel compared to tisagenlecleucel for the treatment of aggressive B-cell lymphoma.
Kwon M; (...); Barba P
Article. 10.3324/haematol.2022.280805. 2023
Axicabtagene Ciloleucel Compared to Tisagenlecleucel for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma in the Real World Setting in Spain
Kwon, Mi; (...); Barba, Pere
Meeting Abstract. 10.1182/blood-2021-147369. 2021
Best Treatment Option for Patients With Refractory Aggressive B-Cell Lymphoma in the CAR-T Cell Era: Real-World Evidence From GELTAMO/GETH Spanish Groups
Bastos-Oreiro, Mariana; (...); Garcia-Sancho, Alejandro Martin
Article. 10.3389/fimmu.2022.855730. 2022
Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study.
Fernandez Rivera C; (...); Hernandez D
Article. 10.1111/ctr.14550. 2022
Clinical Outcomes of Patients with Epstein-Barr Virus-Driven Post-Transplant Lymphoproliferative Disease Following Hematopoietic Stem Cell Transplantation Who Fail Rituximab: A Multinational, Retrospective Chart Review Study
Sanz, Jaime; (...); Mohty, Mohamad
Meeting Abstract. 10.1182/blood-2021-147296. 2021
Comparative Study of Treosulfan Plus Fludarabine (FT14) with Busulfan Plus Fludarabine (FB4) for Acute Myeloid Leukemia in First or Second Complete Remission: An Analysis from the European Society for Blood and Marrow Transplantation (EBMT) Acute Leukemia Working Party (ALWP)
Gavriilaki, Eleni; (...); Mohty, Mohamad
Meeting Abstract. 10.1182/blood-2021-146303. 2021
Comparison of outcomes after unrelated double-unit cord blood and haploidentical peripheral blood stem cell transplantation in adults with acute myeloid leukemia, a study on behalf of Eurocord and ALWP-EBMT.
Ruggeri, Annalisa; (...); Mohty, Mohamad
Article. 10.1016/j.jtct.2022.07.006. 2022
Current Status of CPX-351 Therapy in Acute Myeloid Leukemia and Myelodysplastic Syndrome.
Alotaibi, Shaykhah; (...); Aljurf, Mahmoud
Article. 10.1016/j.clml.2022.02.008. 2022
Daratumumab after allogeneic hematopoietic cell transplantation for multiple myeloma is safe and synergies with pre-existing chronic graft versus host disease. A retrospective study from the CMWP EBMT.
Vincent, Laure; (...); Beksac, Meral
Letter. 10.1038/s41409-021-01560-y. 2022
Efficacy and safety of itacitinib versus placebo in combination with corticosteroids for initial treatment of acute graft-versus-host disease (GRAVITAS-301): a randomised, multicentre, double-blind, phase 3 trial.
Zeiser R; (...); Chen YB
Article. 10.1016/S2352-3026(21)00367-7. 2022
Efficacy and safety of itacitinib versus placebo in combination with corticosteroids for initial treatment of acute graft-versus-host disease (GRAVITAS-301) : a randomised, multicentre, double-blind, phase 3 trial
Zeiser, Robert; (...); Chen, Yi-Bin
Article. 10.1016/S2352-3026(21)00367-7. 2022
Guide to Good Humanization Practices in Patients with Rare Diseases. who vadis
Editorial Material. 2022
Haploidentical Donor Vs. Mismatch Unrelated Donor in Reduced Intensity Conditioning Transplant: A Study from the Spanish Group of Hematopoietic Transplant and Cell Therapy (GETH-TC)
Laura Fox, Maria; (...); Valcarcel, David
Meeting Abstract. 10.1182/blood-2022-167747. 2022
Haploidentical Versus Matched Sibling Donor Hematopoietic Stem Cell Transplantation for Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia: A Study From the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation.
Nagler, Arnon; (...); Mohty, Mohamad
Article. 10.1097/HS9.0000000000000790. 2022
Haploidentical Versus Matched Sibling Donor Hematopoietic Stem Cell Transplantation for Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia: A Study from the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation
Nagler, Arnon; (...); Mohty, Mohamad
Meeting Abstract. 10.1182/blood-2021-144558. 2021
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
Impact of Cytogenetic Risk on Outcomes of Non-T Cell Depleted Haploidentical Hematopoietic Cell Transplantation in Patients with Relapsed or Refractory Acute Myeloid Leukemia.
Nagler, Arnon; (...); Mohty, Mohamad
Article. 10.1016/j.jtct.2022.08.018. 2022
IMPACT OF POSTTRANSPLANT CYCLOPHOSPHAMIDE ON TRANSFUSION REQUIREMENTS IN HLA MATCHED SIBLING PERIPHERAL BLOOD STEM CELL TRANSPLANTATION.
Marco-Ayala, Javier; (...); Solves, Pilar
Article. 10.1016/j.jtct.2023.01.009. 2023
Impact of Scholar-1 Refractoriness Criteria on the Efficacy of CAR-T Therapy in Aggressive B Cell Lymphoma, Compared with Non-Refractory Patients: A Real World Geltamo/Geth Study
Bastos-Oreiro, Mariana; (...); Martin Garcia-Sancho, Alejandro
Meeting Abstract. 10.1182/blood-2022-166329. 2022
Itacitinib and Corticosteroids As Initial Treatment for Chronic Graft-Versus-Host Disease: Phase 1/2 Results from Gravitas-309
Im, Annie; (...); Pavletic, Steven Z.
Meeting Abstract. 10.1182/blood-2022-169605. 2022
Late adverse events in patients with aggressive B-cell lymphoma after CD19-targeted chimeric antigen receptor T-cell therapy
Camacho Arteaga, Lina; (...); Agusti Escasany, Antonia
Meeting Abstract. 2022
Long-Term Outcome of Second Allogeneic Stem Cell Transplantation (HSCT2) for Primary Graft Failure in Patients with Acute Leukemia in Remission: A Study on Behalf of the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation
Nagler, Arnon; (...); Mohty, Mohamad
Meeting Abstract. 10.1182/blood-2022-156231. 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
Metabolic Phenotyping in Prostate Cancer Using Multi-Omics Approaches.
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Article. 10.3390/cancers14030596. 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
Non-T depleted haploidentical stem cell transplantation in AML patients achieving first complete remission after one versus two induction courses: a study from the ALWP/EBMT.
Nagler, Arnon; (...); Mohty, Mohamad
Article. 10.1038/s41409-021-01537-x. 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
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
One-year breakthrough SARS-CoV-2 infection and correlates of protection in fully vaccinated hematological patients.
Piñana JL; (...); Martino R
Article. 10.1038/s41408-022-00778-3. 2023
Outcomes of subsequent neoplasms after umbilical cord blood transplantation in Europe.
Rafii, Hanadi; (...); Gluckman, Eliane
Article. 10.1182/bloodadvances.2022007941. 2022
Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol (vol 8, 372, 2020)
Garcia-Robles, Ana; (...); Aguar Carrascosa, Marta
Correction. 10.3389/fped.2021.834454. 2022
Pharmacotherapeutic management of advanced therapy medicinal products
Luis Poveda-Andres, Jose; (...); Valero-Garcia, Silvia
Article. 10.7399/fh.13036. 2022
Post-transplant cyclophosphamide after HLA identical compared to Haploidentical donor transplant in Acute Myeloid Leukemia: a study on behalf of GETH-TC.
Bailen, Rebeca; (...); Kwon, Mi
Article. 10.1016/j.jtct.2022.01.020. 2022
Post-Transplant Cyclophosphamide after HLA Identical Compared to Haploidentical Donor Transplant in Acute Myeloid Leukemia: A Study on Behalf of Geth-TC
Bailen, Rebeca; (...); Kwon, Mi
Meeting Abstract. 10.1182/blood-2021-150835. 2021
Post-transplant cyclophosphamide and sirolimus based graft-versus-host disease prophylaxis after allogeneic stem cell transplantation for acute myeloid leukemia.
Lazzari, Lorenzo; (...); Sanz, Jaime
Article. 10.1038/s41409-022-01725-3. 2022
Post-transplant Cyclophosphamide in Acute Leukemia Patients Receiving more than 5/10 HLA-Mismatched Allogeneic Hematopoietic Cell Transplantation from Related Donors: a Study on behalf of the ALWP of the EBMT.
Wieczorek, Michele; (...); Mohty, Mohamad
Letter. 10.1002/ajh.26782. 2022
Post-Transplant Cyclophosphamide in Acute Leukemia Patients Receiving More Than 5/10 HLA-Mismatched Allogeneic Stem Cell Transplantation: A Study on Behalf of the ALWP of the EBMT
Wieczorek, Michele; (...); Mohty, Mohamad
Meeting Abstract. 10.1182/blood-2021-151087. 2021
Post-transplant cyclophosphamide separates graft-versus host disease (GVHD) and graft versus leukemia (gvl) effects after HLA- matched stem-cell transplantation (sct) for AML
Shimoni, A.; (...); Mohty, M.
Meeting Abstract. 2022
Post-transplant cyclophosphamide versus antithymocyte globulin in patients with all treated in CR1 with allo-HCT from matched unrelated donors. A study from ALWP of the EBMT
Giebel, S.; (...); Mohty, M.
Meeting Abstract. 2022
Resistance to empirical beta-lactams recommended in febrile neutropenia guidelines in Gram-negative bacilli bloodstream infections in Spain: a multicentre study
Chumbita, Mariana; (...); Garcia-Vidal, Carolina
Article. 10.1093/jac/dkac135. 2022
Role of Allogeneic Hematopoietic Cell Transplant for Relapsed/Refractory Large B-Cell Lymphomas in the CART Era
Mussetti, Alberto; (...); Sureda, Anna
Meeting Abstract. 10.1182/blood-2022-160000. 2022
Ruxolitinib in Acute and Chronic Graft-Versus-Host Disease: Real Life Experience in a Multi-Centre Study
Escamilla Gomez, Virginia; (...); Perez-Simon, Jose A.
Meeting Abstract. 10.1182/blood-2022-164561. 2022
Salvage Treatment with Novel Agents Is Preferable to Standard Chemotherapy in Patients with Large B-Cell Lymphoma Progressing after Chimeric Antigen Receptor T-Cell Therapy
Iacoboni, Gloria; (...); Abrisqueta, Pau
Meeting Abstract. 10.1182/blood-2022-169219. 2022
SARS-CoV-2 vaccine response and rate of breakthrough infection in patients with hematological disorders
Luis Pinana, Jose; (...); Navarro, David
Article. 10.1186/s13045-022-01275-7. 2022
Secondary neoplasms after umbilical cord blood transplantation. On behalf of eurocord and the european group for blood and marrow transplantation
El Ayoubi, H. Rafii; (...); Gluckman, E.
Meeting Abstract. 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
TBI/fludarabine versus busulfan/fludarabine as a myeloablative conditioning for adults with acute myeloid leukemia treated with allo-HCT. A study from the ALWP of the EBMT
Swoboda, R.; (...); Mohty, M.
Meeting Abstract. 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
Thiotepa-based reduced-intensity conditioning are a valid alternative to total-body irradiation-based regimens in patients with acute lymphoblastic leukemia: A study of the alwp of the ebmt
Battipaglia, G.; (...); Mohty, M.
Meeting Abstract. 2022