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  3. ESTUDIO ALEATORIZADO, FASE IIB CONTROLADO CON PLACEBO DE QUIMIOTERAPIA RICE (RITUXIMAB, IFOSFAMIDA, CARBOPLATINO Y ETOPÓSIDO)CON Y SIN SGN-40 (ANTICUERPO MONOCLONAL ANTICD40 HUMANIZADO)PARA EL TRATAMIENTO DE SEGUNDA LÍNEA DE PACIETNES CON LINFOMA DIFUSO D E CÉLULAS GRANDES B (LDCGB)

ESTUDIO ALEATORIZADO, FASE IIB CONTROLADO CON PLACEBO DE QUIMIOTERAPIA RICE (RITUXIMAB, IFOSFAMIDA, CARBOPLATINO Y ETOPÓSIDO)CON Y SIN SGN-40 (ANTICUERPO MONOCLONAL ANTICD40 HUMANIZADO)PARA EL TRATAMIENTO DE SEGUNDA LÍNEA DE PACIETNES CON LINFOMA DIFUSO D E CÉLULAS GRANDES B (LDCGB)

Datos básicos

Código:
SG040-0005
Protocolo:
SG040-0005
EUDRACT:
2007-002917-38
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Dotación:
Año de incio:
Año de finalización:
ENSAYO CLÍNICO

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Financiadores - Promotores

PHARMACEUTICAL PRODUCT DEVELOPMENT SPAIN SL

Resultados del Ensayo Clínico

A multicentre ambispective observational study into the incidence and clinical management of aplastic anaemia in Spain (IMAS study)

Vallejo C; (...); Codesido ML

Article. 10.1007/s00277-023-05602-x. 2024


A randomized phase II study comparing consolidation with a single dose of Y-90 ibritumomab tiuxetan vs. maintenance with rituximab for two years in patients with newly diagnosed follicular lymphoma responding to R-CHOP. Long-term follow-up results

Lopez-Guillermo, Armando; (...); Tomas, Jose Francisco

Article. 10.1080/10428194.2021.1971216. 2021


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


Addition of chemotherapy to nivolumab after PD-1 inhibitor failure as bridge to allogeneic stem cell transplantation in classical Hodgkin's lymphoma: report on three cases and literature review

Romero, S; (...); Sanz, J

Review. 10.1177/20406207211038181. 2021


Adjuvanted recombinant zoster vaccine in adult autologous stem cell transplant recipients: polyfunctional immune responses and lessons for clinical practice

Stadtmauer, Edward A.; (...); ZOE-SCT Study Grp Collaborators

Article. 10.1080/21645515.2021.1953346. 2021


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


Avatrombopag in immune thrombocytopenia: A real-world study of the Spanish ITP Group (GEPTI).

Pascual-Izquierdo C; (...); Mingot-Castellano ME

Article. 10.1002/ajh.27498. 2024


Central Nervous System Involvement in Epstein-Barr Virus-Related Post-Transplant Lymphoproliferative Disorders after Allogeneic Hematopoietic Stem Cell Transplantation.

Balaguer-Rosello, Aitana; (...); Sanz, Jaime

Article. 10.1016/j.jtct.2020.12.019. 2021


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


Chronic liver disease-associated severe thrombocytopenia in Spain: Results from a retrospective study using machine learning and natural language processing.

Calleja-Panero, Jose Luis; (...); Gonzalez Calvo, Jose

Article. 10.1016/j.gastrohep.2023.05.010. 2023


Deciphering predictive factors for choice of thrombopoietin receptor agonist, treatment free responses, and thrombotic events in immune thrombocytopenia (vol 11, 16867, 2021)

Lozano, Maria L.; (...); Vicente, Vicente

Article. 10.1038/s41598-021-95732-x. 2021


Editorial: Infectious diseases and hematology: diagnosis and management

Gonzalez-Lopez, Tomas Jose; (...); Di Micco, Pierpaolo

Editorial Material. 10.3389/fmed.2024.1385874. 2024


Eltrombopag Added to Immunosuppression in Severe Aplastic Anemia.

Peffault de Latour R; (...); Risitano AM

Article. 10.1056/NEJMoa2109965. 2022


ELTROMBOPAG ADDED TO STANDARD IMMUNOSUPPRESSION IMPROVES RESPONSE RATE IN SEVERE APLASTIC ANEMIA: RESULTS OF THE MULTICENTER PHASE III PROSPECTIVE RANDOMIZED RACE TRIAL

Risitano, A. M.; (...); de latour, R. Peffault

Meeting Abstract. 2021

  • Open Access.

ELTROMBOPAG ADDED TO STANDARD IST IS SUPERIOR TO IST ALONE AS FRONT-LINE TREATMENT FOR SEVERE APLASTIC ANEMIA: FINAL 2-YEAR ANALYSIS OF EBMT-SAAWP RACE STUDY

Risitano, Antonio Maria; (...); de Latour, Regis Peffault

Meeting Abstract. 2024


Final Analysis of the Phase 2 ELM-2 Study: Odronextamab in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)

Ayyappan, Sabarish; (...); Prince, H. Miles

Meeting Abstract. 10.1182/blood-2023-179818. 2023


Fostamatinib effectiveness and safety for immune thrombocytopenia in clinical practice.

Gonzalez-Lopez, Tomas Jose; (...); Garcia-Donas Gabaldon, Gloria

Article. 10.1182/blood.2024024250. 2024


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


Health-Related Quality of Life and Symptoms in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Treated with Odronextamab Monotherapy in the Phase 2 ELM-2 Study

Iskierka-Jazdzewska, Elzbieta; (...); Ivanescu, Cristina

Meeting Abstract. 10.1182/blood-2023-180743. 2023


IFISTRATEGY: Spanish National Survey of Invasive Fungal Infection in Hemato-Oncologic Patients.

Vallejo, Carlos; (...); Peman, Javier

Article. 10.3390/jof9060628. 2023


Immunoparesis recovery in newly diagnosed transplant ineligible multiple myeloma patients, an independent prognostic factor that complements minimal residual disease.

Lakhwani S; (...); Hernández MT

Article. 10.1007/s00277-024-06031-0. 2024


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


Incidence and Management of Aplastic Anemia in Spain (IMAS). An Ambispective Study of Biodonostia / Pethema

Vallejo, C; (...); Jarque, I

Meeting Abstract. 2020


Ixazomib Plus Lenalidomide/Dexamethasone (IRd) Versus Lenalidomide /Dexamethasone (Rd) Maintenance after Autologous Stem Cell Transplant in Patients with Newly Diagnosed Multiple Myeloma: Results of the Spanish GEM2014MAIN Trial

Rosinol, Laura; (...); Blade Creixenti, Joan

Meeting Abstract. 10.1182/blood-2021-146798. 2021


Lenalidomide and dexamethasone maintenance with or without ixazomib, tailored by residual disease status in myeloma.

Rosinol, Laura; (...); Blade, Joan

Article. 10.1182/blood.2022019531. 2023


Lenalidomide in combination with R-ESHAP in patients with relapsed or refractory diffuse large B-cell lymphoma: A phase 2 study from GELTAMO.

Martin Garcia-Sancho, A.; (...); Caballero, D.

Article. 10.1111/bjh.18989. 2023


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


Ofatumumab as part of reduced intensity conditioning in high risk B-cell lymphoma patients: final long-term analysis from a prospective multicenter Phase-II Trial

Cabrero M; (...); Caballero D

Article. 10.1038/s41409-023-02171-5. 2024


Ofatumumab as Part of Reduced Intensity Conditioning in High Risk b-cell Lymphoma Patients: Results from a Prospective Multicenter Phase-II Trial

Cabrero, M; (...); Caballero, D

Meeting Abstract. 2020


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


Paradoxical Findings in Patients with Paroxysmal Nocturnal Hemoglobinuria Treated with C5 Inhibitors: Suboptimal Disease Control Perceived As Satisfactory

Gaya, Anna; (...); Vallejo, Carlos

Meeting Abstract. 10.1182/blood-2023-185939. 2023


Primary and secondary immune thrombocytopenia (ITP): Time for a rethink.

Gonzalez-Lopez, Tomas Jose; (...); Fernandez-Fuertes, Fernando

Article. 10.1016/j.blre.2023.101112. 2023


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


Real-life clinical practice in Spain in the setting of new drug availability for ITP treatment. A Delphi-based Spanish expert panel consensus.

Gonzalez-Lopez, Tomas Jose; (...); Jarque, Isidro

Article. 10.1080/09537104.2024.2336104. 2024


Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study).

Abrisqueta, Pau; (...); Villanueva, Miguel

Article. 10.1016/j.clml.2021.07.022. 2021


Recommendations for the Clinical Approach to Immune Thrombocytopenia: Spanish ITP Working Group (GEPTI).

Mingot-Castellano, Maria Eva; (...); Pascual-Izquierdo, Cristina

Article. 10.3390/jcm12206422. 2023


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


Recovery of uninvolved heavy/light chain pair immunoparesis in newly diagnosed transplant-eligible myeloma patients complements the prognostic value of minimal residual disease detection.

Lakhwani S; (...); Hernández MT

Article. 10.3324/haematol.2023.284154. 2024


Relevancia de la anfotericina B liposomal en el tratamiento de las infecciones fúngicas invasoras en pacientes oncohematológicos.

García-Vidal C, Vázquez L, Jarque I

Article. 10.1016/j.riam.2021.03.001. 2021


Results of the Ebmt Saawp Phase III Prospective Randomized Multicenter Race Study of Horse Atg and Ciclosporin with or Without Eltrombopag in Naive Saa Patients

de Latour, RP; (...); Risitano, A

Meeting Abstract. 2020


Sustained Recovery of Uninvolved Heavy/Light Chain Pair Immunoparesis during Maintenance Discriminates Patients with Sustained Negative Minimal Residual Disease

Lakhwani, Sunil; (...); Teodoro Hernandez Garcia, Miguel

Meeting Abstract. 10.1182/blood-2023-179452. 2023


Treatment patterns and outcomes in real-world transplant-ineligible patients newly diagnosed with multiple myeloma

Cejalvo, MJ; (...); de la Rubia, J

Article. 10.1007/s00277-021-04529-5. 2021


Campos de estudio

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