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6 results on '"Bailen R"'

1. Real-world evidence of tisagenlecleucel for the treatment of relapsed or refractory large B-cell lymphoma

Author

Iacoboni G, Villacampa G, Martinez-Cibrian N, Bailen R, Lopez Corral L, Sanchez J, Guerreiro M, Caballero A, Mussetti A, Sancho J, Hernani R, Abrisqueta P, Solano C, Sureda A, Briones J, Martin Garcia-Sancho A, Kwon M, Reguera-Ortega J, Barba P, and GETH G

Abstract

Tisagenlecleucel (tisa-cel) is a second-generation autologous CD19-targeted chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory (R/R) large B-cell lymphoma (LBCL). The approval was based on the results of phase II JULIET trial, with a best overall response rate (ORR) and complete response (CR) rate in infused patients of 52% and 40%, respectively. We report outcomes with tisa-cel in the standard-of-care (SOC) setting for R/R LBCL. Data from all patients with R/R LBCL who underwent leukapheresis from December 2018 until June 2020 with the intent to receive SOC tisa-cel were retrospectively collected at 10 Spanish institutions. Toxicities were graded according to ASTCT criteria and responses were assessed as per Lugano 2014 classification. Of 91 patients who underwent leukapheresis, 75 (82%) received tisa-cel therapy. Grade 3 or higher cytokine release syndrome and neurotoxicity occurred in 5% and 1%, respectively; non-relapse mortality was 4%. Among the infused patients, best ORR and CR were 60% and 32%, respectively, with a median duration of response of 8.9months. With a median follow-up of 14.1months from CAR T-cell infusion, median progression-free survival and overall survival were 3months and 10.7months, respectively. At 12months, patients in CR at first disease evaluation had a PFS of 87% and OS of 93%. Patients with an elevated lactate dehydrogenase showed a shorter PFS and OS on multivariate analysis. Treatment with tisa-cel for patients with relapsed/refractory LBCL in a European SOC setting showed a manageable safety profile and durable complete responses.

Published
2021

2. Post-transplant cyclophosphamide for GVHD prophylaxis compared to ATG-based prophylaxis in unrelated donor transplantation

Author

Bailen R, Kwon M, Pascual-Cascon M, Ferra C, Sanz J, Gallardo-Morillo A, Garcia-Sola A, Torrent A, Jimenez-Lorenzo M, Pinana J, Montoro J, Oarbeascoa G, Dorado N, Gomez-Centurion I, Munoz C, Martinez-Laperche C, Anguita J, Buno I, Diez-Martin J, and Grp Espanol Trasplante Hematopoyet

Subjects
surgical procedures, operative, immune system diseases, GVHD prophylaxis, Post-transplant cyclophosphamide, Unrelated donor HSCT
Abstract

Post-transplant cyclophosphamide (PTCY) effectively prevents graft-versus-host disease after unmanipulated HLA-haploidentical HSCT. The use of PTCY in the unrelated donor HSCT setting is less explored. We conducted a retrospective study of 132 consecutive patients undergoing a matched or 9/10 mismatched unrelated donor HSCT in 4 centers in Spain, 60 with anti-thymocyte globulin (ATG)-based prophylaxis combined with MTX-CsA, and 72 using a PTCY-based regimen. Peripheral blood stem cells were used as graft in most patients (111 patients, 84%); mMUD donors were balanced between groups. Cumulative incidences of grades II-IV and III-IV acute GVHD at 100 days were lower in the PTCy group (46% vs. 67%, p = 0.008; 3% vs. 34%, p = 0.003), without statistically significant differences in the 2-year cumulative incidence of chronic moderate-severe GVHD. At 2 years, no significant differences were observed in overall survival, event-free survival, cumulative incidence of relapse, and non-relapse mortality. GVHD was the most frequent cause of NRM in the ATG group. No differences were observed between groups in the composite endpoint of GVHD-free and relapse-free survival. In this study, PTCy combined with additional immunosuppression after MUD/mMUD HSCT showed a reduction of aGVHD rate with safety results comparable to those obtained with the ATG-based prophylaxis.

Published
2021

5. Allogeneic stem-cell transplantation in HIV-1-infected patients with high-risk hematological disorders

Author

Kwon, M, Bailen, R, Balsalobre, P, Jurado, M, Bermudez, A, Badiola, J, Esquirol, A, Miralles, P, Lopez-Fernandez, E, Sanz, J, Yanez, L, Colorado, M, Pinana, JL, Dorado, N, Solan, L, Laperche, CM, Buno, I, Anguita, J, Serrano, D, and Diez-Martin, JL

Subjects
hematological malignancy, antiretroviral therapy, allogeneic stem-cell transplantation, graft-versus-host disease, HIV
Abstract

Introduction: Although a number of patients with HIV infection and hematological disease have successfully undergone allogeneic hematopoietic stem-cell transplantation (HSCT), short and long-term outcomes remain not well known. We report the largest Spanish experience treating HIV-infected adult patients with high-risk hematological malignancies with allogeneic HSCT. Methods: We retrospectively reviewed 22 HIV-positive patients who received allogeneic HSCT in five centers in Spain. Results: A total of 22 patients with high-risk hematological malignancies were transplanted between 1999 and 2018. Median age was 44 years. With a median follow-up of 65 months (8-112), overall survival and event-free survival were 46%. Nonrelapse mortality was 14% at 12 months and relapse was 24% at 24 months. Grade II-IV acute graft-versus-host disease (GVHD) rate was 44%, and moderate/severe chronic GVHD rate was 41% at 24 months. All patients received combination antiretroviral therapy. Two patients showed severe toxicity related to drug interaction with antiretroviral therapy. 68% of patients showed infectious complications with viral infections as the most frequent cause. Two patients had invasive aspergillosis and one patient presented disseminated tuberculosis. All survivors except one maintained undetectable HIV load at last follow-up after HSCT. Conclusion: Allogeneic HSCT is an effective therapy for high-risk hematological malignancies in patients with HIV infection, and long-term HIV suppression with combination antiretroviral therapy is feasible. However, drug interactions with antiretroviral agents, occurrence of GVHD, and frequent infectious complications account for a complex procedure in this population. Selected HIV-infected patients with hematologic malignancies should be considered for allo-HSCT when indicated, in experienced centers. Copyright (C) 2019 Wolters Kluwer Health, Inc. All rights reserved.

Published
2019

6. Risk factors and outcome of COVID-19 in patients with hematological malignancies

Author

Carmen Eva Perez, Maria Trabazo, Diana Martínez, Irene Garcia-Garcia, Carola Diaz, Rocío Parody, Rosa Coll, José Luis Piñana, Rebeca Bailén, Ignacio De La Fuente, Marta Valero, María-José Jiménez, Irene García-Cadenas, Teresa Zudaire, I Espigado, Agustin Nieto, Ana Serrano, Angel Cedillo, Noemí Fernández, Guiomar Bautista, Adolfo Saez, María Dolores Morales, Luisa Sisinni, Beatriz Merchán, Lourdes Vázquez, Anna Sureda, Laura Fox, Josep-Maria Ribera, Rodrigo Martino, Alejandro Luna, Ana I. Pimentel, Juan Carlos Vallejo, Gonzalo Benzo, Jose Lopez, Carme Talarn, Raquel Saldaña, María Calbacho, Anabelle Chinea, Dunia de Miguel, Maria Carmen Montoya, Manuel Jurado, Irene Gómez-Catalan, Carlos Solano, Marta González-Vicent, Pascual Fernández, Piñana, José Luis, Piñana, José Luis [0000-0001-8533-2562], Infectious Complications Subcommittee of the Spanish Hematopoietic Stem Cell Transplantation and Cell Therapy Group (GETH), [Piñana,JL] Hematology División, Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe, Valencia, Spain. [Piñana,JL] CIBERONC, Instituto Carlos III, Madrid, Spain. [Martino,R, Garcia‑Cadenas,I] Hematology División, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. [García-García,I, Luna,A, Chinea,A, Saez,AJ] Hematology División, Hospital Ramon y Cajal, Madrid, Spain. [Parody,R, Sureda,A] Hematology División, Institut Català Oncologia-Hospital Duran i Reynals, Barcelona, Spain. [Morales,MD, Merchán,B, de Miguel,D] Hematology División, Hospital de Guadalajara, Guadalajara, Spain. [Benzo,G] Hematology División, Hospital La Princesa, Madrid, Spain. [Gómez-Catalan,I, Serrano,A, Montoya,MC] Hematology División, Hospital de Albacete, Albacete, Spain. [Coll,R] Hematology División, Institut Català Oncologia-Hospital Josep Trueta, Girona, Spain. [De La Fuente,I, Pérez,C] Hematology División, Hospital Clínico de Valladolid, Valladolid, Spain. [Diaz,C] Hematology División, Hospital Carlos Haya, Malaga, Spain. [Lopez, JL] Hematology División, Hospital Fundación Jiménez Díaz, Madrid, Spain. [Bailen,R] Hematology División, Hospital Gregorio Marañon, Madrid, Spain. [Zudaire,T] Hematology División, Hospital de Navarra, Navarra, Spain. [Martínez,D] Hematology División, Hospital a Coruña, Coruña, Spain. [Jurado,M] Hematology División, Hospital Virgen de la Nieves, Granada, Spain. [Calbacho,M] Hematology División, Hospital 12 de Octubre, Madrid, Spain. [Vázquez,L] Hematology División, Hospital Universitario de Salamanca, Salamanca, Spain. [Fox,L] Hematology División, Hospital Vall d`Hebron, Barcelona, Spain. [Pimentel,AI] Hematology División, Hospital Clínico Universitario Lozano Blesa, IIS Aragon, Zaragoza, Spain. [Bautista,G] Hematology División, Hospital Puerta de Hierro, Madrid, Spain. [Nieto,A] Hematology División, Hospital de Vigo, Vigo, Spain. [Fernandez,P] Hematology División, Hospital General de Alicante, Alicante, Spain. [Vallejo,JC] Hematology División, Hospital de Donostia, Donostia, Spain. [Solano,C] Hematology División, Hospital Clínico Universitario de Valencia, Valencia, Spain. [Valero,M] Hematology División, Hospital Arnau de Vilanova, Valencia, Spain.[Espigado,I] Department of Hematology, University Hospital Virgen del Rocío/ University of Sevilla, CSIC/ Institute of Biomedicine of Sevilla, Sevilla, Spain. [Saldaña,R] Hematology División, Hospital de Jerez, Jerez, Spain. [Sisinni,L] Pediatric Hematology-Oncology División, Hospital la Paz, Madrid, Spain. [Ribera,JM, Jimenez,MJ] Hematology División, ICO-Hospital Germans Trias i Pujol, Josep Carreras Research Institute, Badalona, Spain. [Trabazo,M] Pediatric División, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. [Gonzalez-Vicent,M] Pediatric División, Hospital niño Jesús, Madrid, Spain. [Fernández,N] Hematology División, Hospital Marqués de Valdecilla, Santander, Spain. [Talarn,C] Hematology División, Hospital Joan XXIII, Tarragona, Spain. [Cedillo,A] Hematopoietic Stem Cell Transplantation and Cell Therapy Group (GETH), Madrid, Spain. [Piñana,JL] Division of Clinical Hematology, Hospital Universitario la Fe de Valencia, Valencia, Spain., Institut Català de la Salut, [Piñana JL] Hematology División, Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe, Valencia, Spain. CIBERONC, Instituto Carlos III, Madrid, Spain. Division of Clinical Hematology, Hospital Universitario la Fe de Valencia, Avda Fernando Abril Martorell, 106 CP 46026 Valencia, Spain. [Martino R] Hematology División, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. [García-García I] Hematology División, Hospital Ramon y Cajal, Madrid, Spain. [Parody R] Hematology División, Institut Català Oncologia-Hospital Duran i Reynals, Barcelona, Spain. [Morales MD] Hematology División, Hospital de Guadalajara, Guadalajara, Spain. [Benzo G] Hematology División, Hospital La Princesa, Madrid, Spain. [Fox L] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
0301 basic medicine, Cancer Research, Diseases::Neoplasms::Neoplasms by Site::Hematologic Neoplasms [Medical Subject Headings], COVID-19 (Malaltia) - Mortalitat, Coronavirus infections, Azithromycin, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Probability::Risk::Risk Factors [Medical Subject Headings], Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], 0302 clinical medicine, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Retrospective Studies [Medical Subject Headings], Reacción en cadena de la polimerasa, virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES], Hematologic neoplasms, Persons::Persons::Age Groups::Adult::Aged [Medical Subject Headings], Hematology, Factors de risc en les malalties, Stem cell transplantation, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Transplantation::Cell Transplantation::Stem Cell Transplantation::Hematopoietic Stem Cell Transplantation [Medical Subject Headings], Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES], lcsh:Diseases of the blood and blood-forming organs, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Prognosis, Multicenter study, Polymerase chain reaction, Oncology, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Transplantation::Cell Transplantation::Stem Cell Transplantation [Medical Subject Headings], 030220 oncology & carcinogenesis, Malalties hematològiques, Factores de riesgo, medicine.drug, medicine.medical_specialty, Pronòstic mèdic, Risk factors in diseases, Infecciones por coronavirus, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Analysis of Variance::Multivariate Analysis [Medical Subject Headings], Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::C-Reactive Protein [Medical Subject Headings], Neutropenia, Hematologia oncològica, lcsh:RC254-282, Trasplante de células madre, 03 medical and health sciences, Other subheadings::Other subheadings::Other subheadings::/mortality [Other subheadings], Internal medicine, medicine, Persons::Persons::Age Groups::Child [Medical Subject Headings], Mortality, neoplasias::neoplasias por localización::neoplasias hematológicas [ENFERMEDADES], Persons::Persons::Age Groups::Adult [Medical Subject Headings], Estudio multicéntrico, Estudio restrospectivo, Geographical Locations::Geographic Locations::Europe::Spain [Medical Subject Headings], Otros calificadores::Otros calificadores::Otros calificadores::/mortalidad [Otros calificadores], Performance status, lcsh:RC633-647.5, business.industry, SARS-CoV-2, Research, Neoplasias hemtaológicas, Hematologic diseases, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Data Collection::Vital Statistics::Mortality [Medical Subject Headings], COVID-19, Retrospective cohort study, Odds ratio, Neoplasms::Neoplasms by Site::Hematologic Neoplasms [DISEASES], medicine.disease, Diseases::Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [Medical Subject Headings], Confidence interval, Retrospective studies, Transplantation, 030104 developmental biology, Sang - Malalties, Mortalidad, Risk factor, business
Abstract

Background Prognostic factors of poor outcome in patients with hematological malignancies and COVID-19 are poorly defined. Patients and methods This was a Spanish transplant group and cell therapy (GETH) multicenter retrospective observational study, which included a large cohort of blood cancer patients with laboratory-confirmed SARS-CoV-2 infection through PCR assays from March 1st 2020 to May 15th 2020. Results We included 367 pediatric and adult patients with hematological malignancies, including recipients of autologous (ASCT) (n = 58) or allogeneic stem cell transplantation (allo-SCT) (n = 65) from 41 hospitals in Spain. Median age of patients was 64 years (range 1–93.8). Recipients of ASCT and allo-SCT showed lower mortality rates (17% and 18%, respectively) compared to non-SCT patients (31%) (p = 0.02). Prognostic factors identified for day 45 overall mortality (OM) by logistic regression multivariate analysis included age > 70 years [odds ratio (OR) 2.1, 95% confidence interval (CI) 1.2–3.8, p = 0.011]; uncontrolled hematological malignancy (OR 2.9, 95% CI 1.6–5.2, p 20 mg/dL (OR 3.3, 95% CI 1.7–6.4, p

Published
2020

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