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1. Etoposide plus cytarabine versus cyclophosphamide or melphalan in busulfan-based preparative regimens for autologous stem cell transplantation in adults with acute myeloid leukemia in first complete remission: a study from the Acute Leukemia Working Party of the EBMT.

Author

Sanz, J., Labopin, M., Pabst, T., Versluis, J., Gorkom, G. van, Meijer, E., Gedde-Dahl, T., Montoro, J., Arcese, W., Pérez-Simón, J.A., Schaap, N.P.M., Maertens, J., Vrhovac, R., Lanza, F., Gorin, N.C., Mohty, M., Ciceri, F., Sanz, J., Labopin, M., Pabst, T., Versluis, J., Gorkom, G. van, Meijer, E., Gedde-Dahl, T., Montoro, J., Arcese, W., Pérez-Simón, J.A., Schaap, N.P.M., Maertens, J., Vrhovac, R., Lanza, F., Gorin, N.C., Mohty, M., and Ciceri, F.

Abstract

Contains fulltext : 299983.pdf (Publisher’s version ) (Closed access), We retrospectively compared the impact of the conditioning regimen in adult patients with acute myeloid leukemia (AML) in first complete remission (CR1) that received high-dose myeloablative chemotherapy followed by autologous stem cell transplantation (ASCT) from 2010 to 2021 with either high-dose cytarabine, etoposide and busulfan (BEA), busulfan with cyclophosphamide (BUCY) or busulfan and high-dose melphalan (BUMEL) registered in the EBMT database. Overall 1560 patients underwent ASCT, of which 156, 1143 and 261 received BEA, BUCY and BUMEL, respectively. Compared to BUCY and BUMEL, BEA patients were younger (p < 0.001) and less frequently had NPM1 mutations (p = 0.03). Transplant outcomes at 5 years with BEA, BUCY and BUMEL were: cumulative incidence of relapse 41.8%, 46.6% and 51.6%; non-relapse mortality (NRM) 1.5%, 5.2% and 7.3%; probability of leukemia-free survival (LFS) 56.7%, 48.2% and 41.1%; and overall survival (OS) 71.3%, 62.3% and 56%, respectively. In multivariable analysis the BEA regimen showed significant improvement in OS compared to BUCY (hazard ratio [HR] 0.65; 95% CI, 0.42-0.83; p = 0.048) and BUMEL (HR 0.59; 95% CI, 0.37-0.94; p = 0.029). In conclusion, high-dose myeloablative combination chemotherapy with BEA offered improved outcomes compared to classical BUCY or BUMEL in patients with AML in CR1 undergoing ASCT., 01 november 2023

Published
2023

3. The Role of TNFR2 and DR3 in the In Vivo Expansion of Tregs in T Cell Depleting Transplantation Regimens

Author

Rodriguez-Barbosa, J.I., Schneider, P., Graca, L., Bühler, L., Perez-Simon, J.A., and Del Rio, M.L.

Subjects
hemic and immune systems, TNF/TNF receptors, graft rejection, graft-versus-host disease, homeostatic proliferation, lymphopenia, regulatory T cells, transplantation
Abstract

Regulatory T cells (Tregs) are essential for the maintenance of tolerance to self and non-self through cell-intrinsic and cell-extrinsic mechanisms. Peripheral Tregs survival and clonal expansion largely depend on IL-2 and access to co-stimulatory signals such as CD28. Engagement of tumor necrosis factor receptor (TNFR) superfamily members, in particular TNFR2 and DR3, contribute to promote peripheral Tregs expansion and sustain their survival. This property can be leveraged to enhance tolerance to allogeneic transplants by tipping the balance of Tregs over conventional T cells during the course of immune reconstitution. This is of particular interest in peri-transplant tolerance induction protocols in which T cell depletion is applied to reduce the frequency of alloreactive T cells or in conditioning regimens that allow allogeneic bone marrow transplantation. These conditioning regimens are being implemented to limit long-term side effects of continuous immunosuppression and facilitate the establishment of a state of donor-specific tolerance. Lymphopenia-induced homeostatic proliferation in response to cytoreductive conditioning is a window of opportunity to enhance preferential expansion of Tregs during homeostatic proliferation that can be potentiated by agonist stimulation of TNFR.

Published
2020

6. 29P ALLELE study: A multicenter, open label, phase III study of tabelecleucel for solid organ or allogeneic hematopoietic cell transplant subjects with Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) after failure of rituximab or rituximab and chemotherapy

Author

Worel, N., primary, Perez-Simon, J.A., additional, Barba, P., additional, Dierickx, D., additional, Hiremath, M., additional, Ye, W., additional, Gamelin, L., additional, Navarro, W.H., additional, and Choquet, S., additional

Published
2020
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8. Autologous stem-cell transplantation in diffuse large B-cell non-Hodgkin's lymphoma not achieving complete response after induction chemotherapy: the GEL/TAMO experience

Author

Rodriguez, J., Caballero, M.D., Gutierrez, A., Solano, C., Arranz, R., Lahuerta, J.J., Sierra, J., Gandarillas, M., Perez-Simon, J.A., Zuazu, J., Lopez-Guillermo, A., Sureda, A., Carreras, E., Garcia-Laraña, J., Marin, J., Garcia, J.C., Fernandez de Sevilla, A., Rifon, J., Varela, R., Jarque, I., Albo, C., Leon, A., SanMiguel, J., and Conde, E.

Published
2004
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9. High-dose therapy in diffuse large cell lymphoma: results and prognostic factors in 452 patients from the GEL-TAMO Spanish Cooperative Group

Author

Caballero, M.D., Pérez-Simón, J.A., Iriondo, A., Lahuerta, J.J., Sierra, J., Marín, J., Gandarillas, M., Arranz, R., Zuazu, J., Rubio, V., Fernández de Sevilla, A., Carreras, E., García-Conde, J., García-Laraña, J., Grande, C., Sureda, A., Vidal, M.J., Rifón, J., Pérez-Equiza, C., Varela, R., Moraleda, J.M., García Ruíz, J.C., Albó, C., Cabrera, R., San Miguel, J.F., and Conde, E.

Published
2003
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10. PF757 REDUCED INTENSITY CONDITIONING AND AVOIDING USE OF BROAD SPECTRUM ANTIBIOTHERAPY ACTIVE AGAINST GRAM-NEGATIVE BACTERIA MIGHT HAVE A CUMULATIVE IMPACT IN REDUCING INTESTINAL MICROBIOTA MISBALANCE

Author

Espigado, I., primary, Rodriguez, N., additional, Labrador, G., additional, Jiménez, S., additional, Aguilar, M., additional, Solano, C., additional, Falantes, J., additional, Vazquez, L., additional, Fernández, C., additional, Kwon, M., additional, Limon, M.C., additional, Márquez-Maraver, F., additional, Fernandez, O., additional, Perez, A., additional, Garcia, I., additional, Cabero, A., additional, Dorado, N., additional, Cordero, J., additional, Molina, J., additional, Montero, M.I., additional, Gonzalez, J., additional, Rosso, C., additional, Pachón, J., additional, Pérez-Simón, J.A., additional, and Ibañez, M.E. Pachón, additional

Published
2019
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12. PS1080 LYMPHOMA ASSOCIATED HEMOPHAGOCYTIC SYNDROME: A SINGLE-CENTER EXPERIENCE

Author

Rojas Martínez, J.A., primary, Prats-Martín, C., additional, Pérez Ortega, L., additional, Morales Camacho, R., additional, Knight Asorey, T., additional, Pérez-López, O., additional, Caballero-Velázquez, T., additional, De la Cruz-Vicente, F., additional, Vargas de los Monteros, M.T., additional, Bernal Ruiz, R., additional, and Pérez-Simón, J.A., additional

Published
2019
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13. PS1029 CLINICAL BENEFIT OF GLASDEGIB PLUS LOW-DOSE CYTARABINE IN PATIENTS WITH DE NOVO AND SECONDARY ACUTE MYELOID LEUKEMIA: LONG-TERM ANALYSIS OF A PHASE 2 RANDOMIZED TRIAL

Author

Heuser, M., primary, Fiedler, W., additional, Sekeres, M.A., additional, Montesinos, P., additional, Leber, B., additional, Merchant, A., additional, Papayannidis, C., additional, Pérez-Simón, J.A., additional, Hoang, C.J., additional, Ma, W.W., additional, Zeremski, M., additional, O’Connell, A., additional, Chan, G., additional, and Cortes, J.E., additional

Published
2019
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17. Extreme Granulocytic Dysplasia in a De Novo Myelodysplastic Syndrome

Author

Rodríguez-Arbolí, E., primary, Morales-Camacho, R., additional, Prats-Martín, C., additional, Carrillo, E., additional, Vargas, M.T., additional, Caballero-Velázquez, T., additional, Montero, I., additional, Falantes, J.F., additional, Pérez-López, O., additional, de Blas, J.M., additional, Verdesoto-Cozzarelli, S., additional, Bernal, R., additional, and Pérez-Simón, J.A., additional

Published
2017
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20. Comparison of ex vivo expansion culture conditions of mesenchymal stem cells for human cell therapy

Author

Perez-Ilzarbe, M. (Maitane), Diez-Campelo, M. (M.), Aranda, P. (P.), Tabera, S. (Soraya), Lopez, T. (Tania), Cañizo, C. (C.) del, Merino, J. (Juana), Moreno, C. (Cristina), Andreu, E.J. (Enrique José), Prosper, F. (Felipe), and Perez-Simon, J.A. (José Antonio)

Subjects
Ciencias de la Salud::Oncología [Materias Investigacion]
Abstract

Mesenchymal stem cells (MSCs) are multipotent stem cells. Based on their properties, several clinical trials have been designed to explore their potential therapeutic effect. Fetal calf serum (FCS, commonly used for in vitro expansion) is an undesirable source of xenogeneic antigens and bears the risk of transmitting contaminations. As an alternative for FCS, platelet lysate (PL) and both autologous and allogeneic human serum have been proposed. The aim of this study is to compare the culture of bone marrow (BM)- derived MSCs in the presence of different serum supplements to determine the effect on cell growth, differentiation potential, and immunologic function.

Published
2009

23. Improvement Over the Years of Long-Term Survival in High-Risk Lymphoma Patients Treated with Hematopoietic Stem Cell Transplantation as Consolidation or Salvage Therapy

Author

Calderón-Cabrera, C., primary, Márquez-Malaver, F.J., additional, de la Cruz-Vicente, F., additional, Falantes, F., additional, Carrillo, E., additional, Parody, R., additional, Montero, I., additional, González Campos, J., additional, Martino, M.L., additional, Carmona, M., additional, Pérez-Simón, J.A., additional, and Espigado, I., additional

Published
2013
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24. O-021 Patterns of infection in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) receiving 5-azacitidine. Candidates for antifungal prophylaxis

Author

Falantes, J., primary, Calderón, C., additional, Márquez-Malaver, F.J., additional, Aguilar, M., additional, Martino, M.L., additional, González, J., additional, Montero, M.I., additional, Parody, R., additional, Espigado, I., additional, and Pérez-Simón, J.A., additional

Published
2013
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26. Prognostic factors for donor lymphocyte infusions following non-myeloablative allogeneic stem cell transplantation in multiple myeloma.

Author

Donk, N.W. van de, Kroger, N., Hegenbart, U., Corradini, P., San Miguel, J., Goldschmidt, H.M.J., Perez-Simon, J.A., Zijlmans, M., Raymakers, R.A.P., Montefusco, V., Ayuk, F.A., Oers, M.H. van, Nagler, A., Verdonck, L.F., Lokhorst, H.M., Donk, N.W. van de, Kroger, N., Hegenbart, U., Corradini, P., San Miguel, J., Goldschmidt, H.M.J., Perez-Simon, J.A., Zijlmans, M., Raymakers, R.A.P., Montefusco, V., Ayuk, F.A., Oers, M.H. van, Nagler, A., Verdonck, L.F., and Lokhorst, H.M.

Abstract

Item does not contain fulltext, In this retrospective study, we evaluated donor lymphocyte infusions given for relapsed (n=48) or persistent (n=15) myeloma following non-myeloablative allogeneic stem cell transplantation (Allo-SCT). Twenty-four of 63 patients (38.1%) responded: 12 patients (19.0%) with a partial response (PR) and 12 patients (19.0%) with a complete response (CR). Overall survival after donor lymphocyte infusions (DLI) was 23.6 months (1.0-50.7+). Median overall survival for non-responding patients was 23.6 months and has not been reached for the patients responding to DLI. In responders, progression-free survival after DLI was 27.8 months (1.2-46.2+). Patients with a PR had a median progression-free survival of 7.0 months, whereas patients with a CR to DLI had a median progression-free survival of 27.8 months. Major toxicities were acute graft-versus-host disease (GVHD) (38.1%) and chronic GVHD (42.9%). Seven patients (11.1%) died from treatment-related mortality. The only significant prognostic factors for response to DLI were the occurrence of acute and chronic GVHD. There was a trend towards significance for time between transplantation and DLI, and response. Donor lymphocyte infusion following non-myeloablative Allo-SCT is a valuable strategy for relapsed or persistent disease.

Published
2006

27. Remarkable activity of novel agents bortezomib and thalidomide in patients not responding to donor lymphocyte infusions following nonmyeloablative allogeneic stem cell transplantation in multiple myeloma.

Author

Donk, N.W. van de, Kroger, N., Hegenbart, U., Corradini, P., San Miguel, J., Goldschmidt, H.M.J., Perez-Simon, J.A., Zijlmans, M., Raymakers, R.A.P., Montefusco, V., Ayuk, F.A., Oers, M.H. van, Nagler, A., Verdonck, L.F., Lokhorst, H.M., Donk, N.W. van de, Kroger, N., Hegenbart, U., Corradini, P., San Miguel, J., Goldschmidt, H.M.J., Perez-Simon, J.A., Zijlmans, M., Raymakers, R.A.P., Montefusco, V., Ayuk, F.A., Oers, M.H. van, Nagler, A., Verdonck, L.F., and Lokhorst, H.M.

Abstract

Item does not contain fulltext

Published
2006

31. Association Between The Hematopoietic Cell Transplantation-Specific Comorbidity Index (CIn) And Non-Relapse Mortality (NRM) After Reduced Intensity Conditioning (RIC) Allogeneic Stem Cell Transplantation (Allo-SCT) For Acute Myeloid Leukemia (AML) In First Complete Remission (CR1)

Author

Mohty, M., primary, Labopin, M., additional, Basara, N., additional, Cornelissen, J., additional, Tabrizi, R., additional, Malm, C., additional, Perez-Simon, J.A., additional, Nagler, A., additional, Kroger, N., additional, Rio, B., additional, Martino, R., additional, Eder, M., additional, Bilger, K., additional, Bunjes, D.W., additional, Socie, G., additional, Blaise, D., additional, Polge, E., additional, and Rocha, V., additional

Published
2010
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32. In Reply

Author

Gonzalez‐Porras, J.R., primary, Graciani, I.F., additional, Perez‐Simon, J.A., additional, Martin‐Sanchez, J., additional, Encinas, C., additional, Conde, M.P., additional, Nieto, M.J., additional, and Corral, M., additional

Published
2008
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33. Non Myeloablative Allogeneic Related Transplant in Patients with Aggressive B Cell Lymphoma: Results of Two Multicenter Spanish Trials. The GELTAMO Group.

Author

Caballero, M.D., primary, Briones, J., additional, Mateos, M.V, additional, Tomás, J.F., additional, Martino, R., additional, de la Serna, J., additional, Díez, J.L., additional, Pérez-Simón, J.A., additional, Sureda, A., additional, Sarrá, J., additional, García-Laraña, J., additional, Ribera, J.M., additional, Sierra, J., additional, and Miguel, J.F. San, additional

Published
2007
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35. Fludarabine and Busulfan-Based Reduced Intensity Conditioning (RIC) Allogeneic HLA-Identical Transplantation (allo-SCT) with or without Anti-Thymocyte Globulin (ATG): Comparison between Two Prospective Studies in Patients with Myeloid Malignancies.

Author

Mohty, Mohamad, primary, Martino, R., primary, Faucher, C., primary, Perez-Simon, J.A., primary, Vey, N., primary, Caballero, M.D., primary, Gastaut, J.A., primary, Miguel, J. San, primary, Blaise, D., primary, and Sierra, J., primary

Published
2004
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36. Risk-factors of melphalan/fludarabine dose-reduced allogeneic stem cell transplantation in patients with multiple myeloma

Author

Kroger, N., primary, Perez-Simon, J.A., additional, Myint, H., additional, Klingemann, H., additional, Shimoni, A., additional, Nagler, A., additional, Martino, R., additional, Allegre, A., additional, Tomas, J., additional, Schwerdtfeger, R., additional, Kiehl, M., additional, Fauser, A., additional, Sayer, H.G., additional, Leon, A., additional, Beyer, J., additional, Zabelina, T., additional, Ayuk, F., additional, San Miguel, J., additional, Brand, R., additional, and Zander, A., additional

Published
2004
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37. Post-transplant cyclophosphamide-based graft-versus-host disease prophylaxis in HLA-matched and haploidentical donor transplants for patients with Hodgkin lymphoma: a comparative study of the LWP EBMT.

Author

Montoro, J, Boumendil, A, Finel, H, Bramanti, S, Castagna, L, Blaise, D, Dominietto, A, Kulagin, A, Yakoub-Agha, I, Tbakhi, A, Solano, C, Giebel, S, Gulbas, Z, López Corral, L, Pérez-Simón, J.A, Díez Martín, J.L, Sanz, J, Farina, L, Koc, Y, Socié, G, Arat, M, Jurado, M, Bermudez, A, Labussière-Wallet, H, Villalba, M, Ciceri, F, Martinez, C, Nagler, A, Sureda, A, and Glass, B

Abstract

•HSCT efficacy and safety in Hodgkin lymphoma using HLA-matched and haploidentical donors with PTCy GVHD prophylaxis.•HLA-matched had lower NRM, resulting in higher OS compared to haploidentical.•Our study supports HLA-matched donors with PTCy GVHD prophylaxis over haploidentical donors.

Published
2023
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40. Chimerism and minimal residual disease monitoring after reduced intensity conditioning (RIC) allogeneic transplantation.

Author

Perez-Simon, J.A. and Caballero, D.

Subjects
*GRAFT versus host disease, *LEUKEMIA
Abstract

Since graft-versus-leukemia (GVL) is the main weapon for disease eradication after reduced intensity conditioning (RIC) allogeneic SCT, the availability of sensitive and specific techniques to monitor changes in tumor load after transplant are especially helpful. These minimal residual disease techniques would allow an early intervention in the event of low tumor burden, for which immunotherapy is highly effective. Some authors have found an association between persistence of MRD, mixed chimerism and risk of relapse. Nevertheless, data from the literature remain contradictory and further correlations should be established, especially in RIC transplants. In this study we have analyzed the impact of MRD and chimerism monitoring on the outcome of 34 patients undergoing RIC allogeneic SCT who were considered poor candidates for conventional transplantation due to advanced age or other concurrent medical conditions. At day +100 25 (75%) patients reached complete remission (CR), there were five (15%) partial responses and three patients progressed. Incidence of grade 2-4 aGVHD and extensive cGVHD were 35% and 58%, respectively. Sixteen percent of patients developing aGVHD relapsed as compared to 47% in those without aGVHD (P = 0.03) and also 10% of patients developing cGVHD relapsed as compared to 50% relapses in those without cGHVD (P = 0.03). Four patients (12%) died due to early (n = 1) and late (n = 3) transplant-related mortality. After a median follow-up of 15 months, 24 out of the 34 patients remain alive. Projected overall survival and disease-free survival at 3 years are 68% and 63%, respectively. Early chimerism analysis showed 67% of patients with complete chimerism (CC) in bone marrow (BM), 86% in peripheral blood (PB), 89% in granulocytes and 68% in T lymphocytes. On day +100, these figures were 68%, 79%, 90% and 73%, respectively, and on day +180 there were 83% patients with CC in BM, 100% in PB, 100% in granulocytes and 100% in T lymphocytes. We... [ABSTRACT FROM AUTHOR]

Published
2002

42. Comparison between a lyse-and-then-wash method and a lyse-non-wash technique for the enumeration of CD34+ hematopoietic progenitor cells

Author

Menéndez, P., Redondo, O., Rodriguez, A., Lopez-Berges, M.C., Ercilla, G., López, A., Durán, A., Almeida, J., Pérez-Simón, J.A., Miguel, J.F. San, and Gratama, J.W.

Abstract

The flow cytometric enumeration of CD34+ hemopoietic precursor cells (HPC) present in samples used for transplantation of HPC has proven to be the most powerful single parameter for prediction of engraftment. At present, several different methodological approaches are used for the flow cytometric enumeration of CD34+ HPC. In the present study we have compared two of these methods as regards enumeration of CD34+ HPC and their CD34+/CD19− and CD34+/CD19+ subsets: a lyse-non-wash procedure based on the use of a recently commercialized red cell lysing solution (Quicklysis, Cytognos, Salamanca, Spain) and a lyse-and-then-wash method in which the Becton Dickinson (San Jose, CA) FACS Lysing Solution was used. For that purpose a total of 52 samples corresponding to 20 G-CSF mobilized peripheral blood (PB) samples and 21 PB-derived leucapheresis products from patients undergoing autologous PB stem cell harvest, together with 11 bone marrow (BM) samples from healthy volunteers were analyzed. Our results show that for each of the three types of samples analyzed the use of the lyse-and-then-wash method is associated with significantly lower numbers of both total CD34+ HPC (P ≤ 0.003) and its major CD34+/CD19− subset (P ≤ 0.01) while no significant changes are detected in the number of CD34+/CD19+ HPC in BM samples (P > 0.05). The use of an internal standard (reference beads) added just prior to data acquisition, showed that the differences between both methods are due to a selective loss of CD34+ HPC and its major CD34+/CD19− subset in BM (P = 0.002 and P = 0.003), PB (P &lt; 0.0001 and P &lt; 0.0001) and PB-derived leucapheresis products (P  &lt; 0.0001 and P = 0.0001). Finally, addition of a centrifugation and washing step to a group of 11 leucapheresis samples lysed with Quicklysis showed that they did not significantly affect the overall number of total CD34+, CD34+/CD19− and CD34+/CD19+ HPC obtained. In line with these findings elimination of centrifugation and washing steps when FACS Lysing Solution was used to lyse mature red cells almost corrected for the selective loss of CD34+ HPC. In spite of these differences a significant degree of correlation (r > 0.83 in all cases) was found between both methods regarding the total number of CD34+, CD34+/CD19− and CD34+/CD19+ HPC present in the BM, PB and PB-derived leucapheresis samples analyzed in this study. Cytometry (Comm. Clin. Cytometry) 34:264–271, 1998. © 1998 Wiley-Liss, Inc.

Published
1998
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43. Proportion of S-phase tumor cells measured by flow cytometry is an independent prognostic factor in meningioma tumors

Author

Maíllo, A., Díaz, P., Blanco, A., López, A., Ciudad, J., Hernández, J., Morales, F., Pérez-Simón, J.A., and Orfao, A.

Abstract

Meningiomas are tumors in arachnoid cells which represent up to one fifth of all intracranial tumors and up to a quarter of spinal neoplasias. Although meningiomas have classically been considered to be benign tumors, it has also been well-established that they show a heterogeneous clinical outcome. To the best of our knowledge no study has yet been performed in which the independent prognostic value of both DNA ploidy and cell cycle has been simultaneously assessed in a large series of meningioma tumors. The aim of the present study was to prospectively explore the prognostic value of DNA ploidy status and the proliferative rate of tumor cells in a series of 105 consecutive meningioma patients studied at diagnosis. Both the presence of DNA aneuploidy and the proportion of S-phase tumor cells were analyzed in all cases in fresh tumors obtained during diagnostic surgery. From the technical point of view, we followed the recommendations of the Consensus Conference on Flow Cytometry DNA Analysis held in October 1992. Our results show that meningioma tumors display a relatively low incidence of DNA aneuploidy (14%), and they usually show a low proliferative rate (mean percentage of S-phase cells of 1.3 ± 0.3%). The presence of DNA aneuploidy was associated with a higher incidence of aggressive histopathologic subtypes (P = 0.045), a greater age (P = 0.009), location at the cerebral convexity (P = 0.004), and a greater proportion of S-phase cells (P = 0.005). In contrast, no significant association between the DNA ploidy status of meningioma patients and their disease-free survival was found (P = 0.1). Regarding the proliferative activity of neoplastic cells, we found that a high proportion of S-phase cells (>1.8%) was associated with a significantly lower mean age (P = 0.007), aggressive histopathologic subtypes (P = 0.03), a higher incidence of DNA aneuploidy (P = 0.004), and a significantly shorter disease-free survival (P &lt; 0.004). Multivariate analysis of prognostic factors showed that the proportion of S-phase tumor cells was the most powerful independent prognostic factor in meningioma patients (P = 0.02). In summary, we conclude that the porportion of S-phase tumor cells represents the individual parameter with the highest value for predicting disease-free survival in meningioma patients. Cytometry (Comm. Clin. Cytometry) 38:118–123, 1999.  © 1999 Wiley-Liss, Inc.

Published
1999
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46. Feasibility and Efficacy of a Planned Second Transplant (“auto” or “mini-allo”) Intensification in Patients with Multiple Myeloma (MM) Not Achieving Complete Remission (CR) or Near-CR with a First Autologous Transplant. Results from a Spanish PETHEMA/GEM Study.

Author

Rosiñol, L., Lahuerta, J.J., Sureda, A., de la Rubia, J., García-Laraña, J., Hernández-García, M., Hernández-Ruíz, B., Pérez-Simón, J.A., Bello, J.L., Carrera, D., Peñarrubia, M.J., Abella, E., León, A., Poderós, C., García-Ruíz, J.C., Besalduch, J., Martínez-Martínez, R., Pérez-Fernández, I., Ribas, P., Escalante, F., Miguel, J. San, and Bladé., J.

Published
2005
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47. Mesenchymal stem cells expanded in vitro with human serum for the treatment of acute and chronic graft-versus-host disease: results of a phase I/II clinical trial

Author

Perez-Simon, J.A. (José Antonio)

Subjects
Graft versuss Host disease, Treatment outcome, Cells, Mesenchymal stromal cells, Clinical trial, Phase I, Clinical trial, Phase II, Humans, Transplantation, homologous
Abstract

This trial evaluated the feasibility and efficacy of the infusion of mesenchymal stem cells expanded using human serum for the treatment of refractory acute or chronic graft-versus-host disease. Twenty-eight expansions were started. In 22, a minimum of more than 1 x 10⁶ mesenchymal stem cells/kg were obtained after a median of 26 days; this threshold was not obtained in the remaining cases. Ten patients received cells for the treatment of refractory or relapsed acute graft-versus-host disease and 8 for chronic disease. One patient treated for acute graft-versus-host disease obtained a complete response, 6 had a partial response and 3 did not respond. One of the chronic patients achieved complete remision, 3 a partial response, and 4 did not respond. The current study supports the use of this approach in less heavily treated patients for both acute and chronic graft-versus-host disease. The trial has been registered at ClinicalTrials.gov: identifier NCT00447460.

Published
2011

48. Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial

Author

Nathan Hale Fowler, Michael Dickinson, Martin Dreyling, Joaquin Martinez-Lopez, Arne Kolstad, Jason Butler, Monalisa Ghosh, Leslie Popplewell, Julio C. Chavez, Emmanuel Bachy, Koji Kato, Hideo Harigae, Marie José Kersten, Charalambos Andreadis, Peter A. Riedell, P. Joy Ho, José Antonio Pérez-Simón, Andy I. Chen, Loretta J. Nastoupil, Bastian von Tresckow, Andrés José María Ferreri, Takanori Teshima, Piers E. M. Patten, Joseph P. McGuirk, Andreas L. Petzer, Fritz Offner, Andreas Viardot, Pier Luigi Zinzani, Ram Malladi, Aiesha Zia, Rakesh Awasthi, Aisha Masood, Oezlem Anak, Stephen J. Schuster, Catherine Thieblemont, Fowler N.H., Dickinson M., Dreyling M., Martinez-Lopez J., Kolstad A., Butler J., Ghosh M., Popplewell L., Chavez J.C., Bachy E., Kato K., Harigae H., Kersten M.J., Andreadis C., Riedell P.A., Ho P.J., Perez-Simon J.A., Chen A.I., Nastoupil L.J., von Tresckow B., Ferreri A.J.M., Teshima T., Patten P.E.M., McGuirk J.P., Petzer A.L., Offner F., Viardot A., Zinzani P.L., Malladi R., Zia A., Awasthi R., Masood A., Anak O., Schuster S.J., Thieblemont C., Novartis Foundation for Sustainable Development, Clinical Haematology, AII - Cancer immunology, CCA - Cancer biology and immunology, and CCA - Cancer Treatment and Quality of Life

Subjects
Adult, B-cell lymphoma, Antigens, CD19, Medizin, Receptors, Antigen, T-Cell, Pilot Projects, Cancer immunotherapy, General Medicine, Immunotherapy, Adoptive, General Biochemistry, Genetics and Molecular Biology, Phase II trials, Humans, B-cell lymphoma, Tisagenlecleucel, T cell therapy, Lymphoma, Follicular
Abstract

Tisagenlecleucel is an autologous anti-CD19 chimeric antigen receptor-T cell therapy with clinically meaningful outcomes demonstrated in patients with relapsed/refractory (r/r) B-cell lymphoma. In a previous pilot study of tisagenlecleucel in r/r follicular lymphoma (FL), 71% of patients achieved a complete response (CR). Here we report the primary, prespecified interim analysis of the ELARA phase 2 multinational trial of tisagenlecleucel in adults with r/r FL after two or more treatment lines or who relapsed after autologous stem cell transplant (no. NCT03568461). The primary endpoint was CR rate (CRR). Secondary endpoints included overall response rate (ORR), duration of response, progression-free survival, overall survival, pharmacokinetics and safety. As of 29 March 2021, 97/98 enrolled patients received tisagenlecleucel (median follow-up, 16.59 months; interquartile range, 13.8–20.21). The primary endpoint was met. In the efficacy set (n = 94), CRR was 69.1% (95% confidence interval, 58.8–78.3) and ORR 86.2% (95% confidence interval, 77.5–92.4). Within 8 weeks of infusion, rates of cytokine release syndrome were 48.5% (grade ≥3, 0%), neurological events 37.1% (grade ≥3, 3%) and immune effector cell-associated neurotoxicity syndrome (ICANS) 4.1% (grade ≥3, 1%) in the safety set (n = 97), with no treatment-related deaths. Tisagenlecleucel is safe and effective in extensively pretreated r/r FL, including in high-risk patients., The study was sponsored and designed by Novartis Pharmaceuticals Corporation and was approved by the IRB at each participating institution.

Published
2021

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