Estudio de fase Ib/II y abierto de siremadlin en monoterapia y en combinación con infusión de linfocitos del donante como tratamiento para pacientes con leucemia mieloide aguda que han recibido un trasplante alogénico de células madre hematopoyéticas y que están en remisión completa pero presentan un riesgo elevado de recaída.

Datos básicos

Protocolo:
CHDM201K12201
EUDRACT:
2021-003596-34
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Año de incio:
2023
Año de finalización:
2024
ENSAYO CLÍNICO

Objetivos del proyecto

Objetivo Principal: Objetivos principales de seguridad: -Determinar la dosis y pauta de siremadlin en monoterapia que son tolerables sin toxicidades inaceptables(dosis de carga recomendada para futuras investigaciones),medidas mediante incidencia de toxicidades limitantes de dosis(DLT). -Determinar la dosis y pauta de siremadlin en combinación con DLI que son tolerables sin que se produzcan toxicidades inaceptables(dosis recomendada para la combinación)medidas mediante el tiempo hasta DLT. Objetivos principales de eficacia: -Evaluar la eficacia preliminar de siremadlin(con una fase de dosis de carga en monoterapia,en combinación con DLI después de fase de dosis de carga en monoterapia y en monoterapia como mantenimiento después de fase de carga o de combinación con DLI)en la prevención de recaída hematológica,medida mediante la proporción de participantes que están vivos y mantienen RC o RCi sin evidencia de recaída hematológica durante al menos 6 meses después del inicio del tratamiento del estudio. Objetivos Secundarios: -Evaluar la supervivencia sin recaída (RFS). -Evaluar la incidencia acumulada de recaídas al año y a los 2 años después del inicio del tratamiento del estudio. -Evaluar la supervivencia global (OS). -Evaluar el efecto del tratamiento del estudio sobre el estado de la enfermedad residual medible (EMR) durante los 6 primeros meses del tratamiento del estudio. -Evaluar la seguridad y la tolerabilidad de siremadlin en monoterapia (durante la fase de dosis de carga y de mantenimiento) y en combinación con DLI. -Evaluar la proporción de participantes que interrumpen el tratamiento del estudio debido a la enfermedad de injerto contra receptor (EICR) u otros acontecimientos adversos. -Evaluar la incidencia de la EICR aguda de grado III y IV y de la EICR crónica moderada y grave. -Evaluar la supervivencia sin recaída ni EICH (GRFS). -Caracterizar la farmacocinética de siremadlin en monoterapia y en combinación con DLI.

Documentos

  • No hay documentos

Participantes

Grupos

Financiadores - Promotores

NOVARTIS FARMACEUTICA, S.A.

Resultados del Ensayo Clínico


[[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

  • Open Access.

[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services

Company Albir MJ, Andrés JLP, Solsona MDE

Article. 10.1016/j.farma.2023.10.004. 2024

  • Open Access.

In vitro assessment of the combined effect of letermovir and sirolimus on cytomegalovirus replication

Gimenez, Estela; (...); Navarro, David

Article. 10.37201/req/016.2023. 2023

  • Open Access.

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

  • Open Access.

A global study for acute myeloid leukemia with RARG rearrangement.

Zhu, Hong-Hu; (...); Chen, Su-Ning

Article. 10.1182/bloodadvances.2022008364. 2023

  • Open Access.

Accuracy and prognostic impact of FDG PET/CT and biopsyin bone marrow assessment of follicular lymphomaat diagnosis: A Nation-Wide cohort study.

Rodenas-Quinonero, Isabel; (...); Ortuno, Francisco Jose

Article. 10.1002/cam4.5424. 2022

  • Open Access.

Alternative Donor Transplantation for Severe Aplastic Anemia: A Comparative Study of the Saawp EBMT

Montoro, Juan; (...); De Latour, Regis Peffault

Meeting Abstract. 10.1182/blood-2023-174724. 2023


Allogeneic hematopoietic cell transplant for hairy cell leukemia: EBMT experience.

Chihara D; (...); Yakoub-Agha I

Letter. 10.3324/haematol.2022.281754. 2023

  • Open Access.

ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANT IN ADULT PATIENTS WITH IDH MUTATED AML AND MDS: A STUDY FROM THE GRUPO ESPANOL DE TRASPLANTE HEMATOPOYETICO Y TERAPIA CELULAR

Perez-Gonzalez, Ana; (...); Orti Pascual, Guillermo

Meeting Abstract. 2023


Allogeneic hematopoietic cell transplantation for patients with AML aged 70 years or older in first remission. A study from the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation (EBMT).

Maffini, Enrico; (...); Mohty, Mohamad

Article. 10.1038/s41409-023-02027-y. 2023


Allogeneic hematopoietic stem cell transplantation achieves long-term survival in Natural killer/T-cell lymphoma in the era of Asparaginase-based Chemotherapy

Berning, P.; (...); Glass, B.

Meeting Abstract. 2023


Allogeneic hematopoietic stem cell transplantation for NK/T-cell lymphoma: an international collaborative analysis.

Berning, Philipp; (...); Glass, Bertram

Article. 10.1038/s41375-023-01924-x. 2023

  • Open Access.

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

  • Open Access.

Allogeneic stem cell transplantation for patients with acute myeloid 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

Article. 10.1038/s41409-023-01940-6. 2023

  • Open Access.

ANTITHYMOCYTE GLOBULIN - OR ALEMTUZUMAB-BASED GVHD PROPHYLAXIS IN REDUCED- INTENSITY CONDITIONING ALLO-HCT FOR ACUTE LYMPHOBLASTIC LEUKEMIA IN CR1: A STUDY FROM THE ACUTE LEUKEMIA WORKING PARTY

Bug, Gesine; (...); Mohty, Mohamad

Meeting Abstract. 2023


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

  • Open Access.

Autologous Stem Cell Transplantation Remains a Curative Option As Second Line Treatment for Patients with Relapsed/Refractory Large B Cell Lymphoma: Spanish Multicenter Geth-TC/Geltamo Study

Bento, Leyre; (...); Garcia-Sancho, Alejandro Martin

Meeting Abstract. 10.1182/blood-2023-186730. 2023


Bispecific T-Cell Engagers for B-Cell NON-Hodgkin Lymphoma Patients before Allogeneic Stem Cell Transplantation. a Study on Behalf Od Geth-TC

Pena, Marta; (...); Balari, Anna Maria Sureda

Meeting Abstract. 10.1182/blood-2023-181815. 2023

  • Open Access.

CA125: a new biomarker in patients with Fontan circulation (vol 76, pg 112, 2023)

Fuentes, Francisco Buendia; (...); Soriano, Joaquin Rueda

Correction. 10.1016/j.rec.2023.03.018. 2023


CART-AI-Radiomics: Survival and Neurotoxicity Prediction in B-Cell Lymphoma Patients Treated with CAR-T Cells through an Imaging Features-Based Model

Ferrer Lores, Blanca; (...); Jose Terol, Maria

Meeting Abstract. 10.1182/blood-2023-185088. 2023


Cis-Acting Splicing-Associated Variants Can Redefine the Molecular Signature of Genes Commonly Mutated in Acute Myeloid Leukemia

Morote-Faubel, Mireya; (...); Cervera, Jose

Meeting Abstract. 10.1182/blood-2023-177571. 2023

  • Open Access.

CLINICAL AND MOLECULAR CHARACTERIZATION OF PATIENTS WITH THERAPY RELATED MYELOID NEOPLASMS

Calvete, O.; (...); Sole, F.

Meeting Abstract. 10.1016/j.leukres.2023.107176. 2023


Clinical and Molecular Characterization of Patients with Therapy Related Myeloid Neoplasms ( TRMN)

Calvete, Oriol; (...); Kanagal-Shamanna, Rashmi

Meeting Abstract. 10.1182/blood-2023-188701. 2023

  • Open Access.

Clinical experience of whole body and tumour dosimetry of 131-I-mIBG treatment for pediatric patients

Espallardo, I. Torres; (...); Prado-Wohlwend, S.

Meeting Abstract. 2023


CMV REACTIVATIONS IN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT FROM HLA-MATCHED AND HAPLOIDENTICAL DONORS WITH POST-TRANSPLANT CYCLOPHOSPHAMIDE.

Chorão P; (...); Sanz J

Article. 10.1016/j.jtct.2024.01.082. 2024

  • Open Access.

CNS Prophylaxis in Adult ALL Patients after Stem Cell Transplantation: An EBMT Survey on General Practice

Chiusolo, Patrizia; (...); Ciceri, Fabio

Meeting Abstract. 10.1182/blood-2023-182831. 2023

  • Open Access.

ComBat harmonization in different PET imaging scenarios

Gandia-Ferrero, M.; (...); Marti-Bonmati, L.

Meeting Abstract. 2023


Comparing Older Matched Related to Younger Matched Unrelated Donors in Acute Myeloid Leukemia in Remission Using Post-Transplant Cyclophosphamide

Piemontese, Simona; (...); Ciceri, Fabio

Meeting Abstract. 10.1182/blood-2023-182923. 2023

  • Open Access.

Comparison of protocols with respiratory-gated (4D) motion compensation in PET/CT: open-source package for quantification of phantom image quality.

Martinez-Movilla, Andrea; (...); Carles, Montserrat

Article. 10.1186/s40658-022-00509-4. 2022

  • Open Access.

Comprehensive detection of CRLF2 alterations in acute lymphoblastic leukemia: a rapid and accurate novel approach.

Gil, Jose Vicente; (...); Barragan, Eva

Article. 10.3389/fmolb.2024.1362081. 2024

  • Open Access.

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano JB; (...); Soto-Ortega I

Article. 10.1016/j.farma.2023.01.003. 2023

  • Open Access.

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


Cord blood transplantation for adult mature lymphoid neoplasms in Europe and Japan.

Watanabe, Mizuki; (...); Gluckman, Eliane

Article. 10.1182/bloodadvances.2023010598. 2024

  • Open Access.

CORD BLOOD TRANSPLANTATION FOR AML: COMPARABLE LFS IN PATIENTS WITH DE NOVO VERSUS SECONDARY AML

Baron, Frederic; (...); Ciceri, Fabio

Meeting Abstract. 2023


Cord blood transplantation for AML: Comparable LFS in patients with de novo versus secondary AML in CR1, an ALWP/EBMT study.

Baron, Frederic; (...); Ciceri, Fabio

Article. 10.1111/bjh.19130. 2023

  • Open Access.

Correction: Role of allogeneic hematopoietic cell transplant for relapsed/refractory aggressive B-cell lymphomas in the CART era.

Mussetti, Alberto; (...); Sureda, Anna

Correction. 10.1038/s41409-023-01967-9. 2023

  • Open Access.

Cytogenetic Assessment and Risk Stratification in Myelofibrosis with Optical Genome Mapping.

Diaz-Gonzalez, Alvaro; (...); Such, Esperanza

Article. 10.3390/cancers15113039. 2023

  • Open Access.

Cytomegalovirus DNAemia in hematological patients undergoing CD19-directed CAR-T cell therapy: should it be systematically monitored?

Solano de la Asuncion, Carlos; (...); Navarro, David

Letter. 10.1016/j.cmi.2023.05.010. 2023


Cytomegalovirus-driven early-onset lymphocytosis in hematopoietic allogeneic transplant mimicking a T-cell lymphoma progression.

Eiris, Juan, Aguilar, Cristobal, Guerreiro, Manuel

Article. 10.1111/tid.14170. 2023

  • Open Access.

Characterization of a translocation that disrupts the COL4A5 gene in a girl with Alport syndrome by optical genome mapping

Orellana, Carmen; (...); Diaz, Alvaro

Meeting Abstract. 2024

  • Open Access.

Design and Validation of a Custom Next-Generation Sequencing Panel in Pediatric Acute Lymphoblastic Leukemia.

Gil, Jose Vicente; (...); Barragan, Eva

Article. 10.3390/ijms24054440. 2023

  • Open Access.

DESIGN AND VALIDATION OF AN ACUTE LYMPHOBLASTIC LEUKEMIA-TARGETED NEXT-GENERATION SEQUENCING PANEL

Gil, JV.; (...); Llop, M.

Meeting Abstract. 2023


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

  • Open Access.

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

  • Open Access.

Disseminated toxoplasma infection after hematopoietic stem cell transplantation with myositis and encephalitis.

Asensi Cantó P; (...); Guerreiro M

Article. 10.1111/tid.14067. 2023

  • Open Access.

EASIX AS A PREDICTOR INDEX FOR NEUROLOGICAL COMPLICATIONS AFTER ANTI-CD19 CAR-T CELL THERAPY IN AGGRESSIVE B-CELL LYMPHOMAS: A STUDY FROM THE GETHTC GROUP

Pena Domingo, Marta; (...); Sureda, Anna

Meeting Abstract. 2023


Efficacy of Chimeric Antigen Receptor T-Cell Therapy Is Not Impaired By Previous Bispecific Antibody Treatment in Patients with Large B-Cell Lymphoma

Iacoboni, Gloria; (...); Morschhauser, Franck

Meeting Abstract. 10.1182/blood-2023-185035. 2023

  • Open Access.

Enhancing Cytogenetic Diagnostics: Incorporating Optical Genome Mapping in the Laboratory Routine

Diaz-Gonzalez, Alvaro; (...); Such, Esperanza

Meeting Abstract. 10.1182/blood-2023-180691. 2023

  • Open Access.

ERCC6L2 in Early-Onset Adult Myelodysplastic Syndrome without Pre-Existing Disorder

Carrillo-Tornel, Salvador; (...); Jerez, Andres

Meeting Abstract. 10.1182/blood-2022-168759. 2022

  • Open Access.

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.

Sanz, Jaime; (...); Ciceri, Fabio

Article. 10.1038/s41409-023-02075-4. 2023

  • Open Access.

EXTRACORPOREAL PHOTOPHERESIS IN GRAFT-VERSUS-HOST DISEASE.

Canto, Pedro Asensi; (...); Segui, Ines Gomez

Article. 10.1016/j.jtct.2023.07.001. 2023

  • Open Access.

Features of cytomegalovirus DNAemia and virus-specific T-cell responses in allogeneic hematopoietic stem-cell transplant recipients during prophylaxis with letermovir.

Gimenez, Estela; (...); Navarro, David

Article. 10.1111/tid.14021. 2023

  • Open Access.

Female Sex Effect on Anti-CD19 CART Cell Therapy for Relapsed/Refractory B-Cell Lymphoma: A Grupo Espanol De Trasplante y Terapia Celular (GETH-TC) Study

Fabbri, Nicole; (...); Mussetti, Alberto

Meeting Abstract. 10.1182/blood-2023-185721. 2023

  • Open Access.

Free automatic software for quality assurance of computed tomography calibration, edges and radiomics metrics reproducibility.

Saborido-Moral, Juan D.; (...); Carles, Montserrat

Article. 10.1016/j.ejmp.2023.103153. 2023

  • Open Access.

GERMLINE PREDISPOSITION TO MYELOID MALIGNANCIES IN A CONSECUTIVE COHORT OF 183 PATIENTS

Santiago, M.; (...); Cervera-Zamora, J.

Meeting Abstract. 10.1016/j.leukres.2023.107247. 2023


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

  • Open Access.

High Rate of Inappropriate Antibiotics in Patients with Hematologic Malignancies and Pseudomonas aeruginosa Bacteremia following International Guideline Recommendations.

Chumbita, Mariana; (...); Garcia-Vidal, Carolina

Article. 10.1128/spectrum.00674-23. 2023

  • Open Access.

How can artificial intelligence optimize value-based contracting?

Poveda, Jose Luis; (...); Medrano, Ignacio H.

Letter. 10.1186/s40545-022-00475-3. 2022

  • Open Access.

IKZF1 Deletions Are Markers of Treatment Resistance in Adult Ph-Negative B-Cell Acute Lymphoblastic Leukemia Patients Treated within the Ongoing Risk-Adapted Pethema LAL19 Trial

Ribera, Jordi; (...); Ribera, Josep-Maria

Meeting Abstract. 10.1182/blood-2022-162159. 2022

  • Open Access.

IMPACT OF BUSULFAN, ETOPOSIDE AND HIGH-DOSE ARA-C (BEA) CONDITIONING FOR AUTOLOGOUS STEM CELL TRANSPLANTATION IN AML

Sanz, Jaime; (...); Ciceri, Fabio

Meeting Abstract. 2023


Impact of measurable residual disease on outcomes of unrelated donor haematopoietic cell transplantation with post-transplant cyclophosphamide in AML in first complete remission.

Nagler, Arnon; (...); Mohty, Mohamad

Article. 10.1111/bjh.18765. 2023

  • Open Access.

Impact of Patient Selection and Management over Different Time Periods on the Outcome of Patients with Large B-Cell Lymphoma Receiving Chimeric Antigen Receptor T-Cell Therapy

Torrent, Anna; (...); Barba, Pere

Meeting Abstract. 10.1182/blood-2023-186388. 2023


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

  • Open Access.

Impact of SCHOLAR-1 criteria on CAR-T cell therapy efficacy in aggressive B lymphoma. A real-world GELTAMO/GETH study.

Oreiro MB; (...); García-Sancho AM

Article. 10.1016/j.jtct.2023.08.026. 2023

  • Open Access.

Improved outcomes in allo-HCT for multiple myeloma patients with thiotepa-busulfan-fludarabine conditioning regimen and post-transplant cyclophosphamide, sirolimus and mycophenolate mofetil

de la Rubia, Javier; (...); Sanz, Miguel

Meeting Abstract. 2023


Incidence and prognostic impact of U2AF1 mutations and other gene alterations in myelodysplastic neoplasms with isolated 20q deletion.

Castillo MI; (...); Díaz TM

Article. 10.1002/cam4.6300. 2023

  • Open Access.

Long-term outcome of second allogeneic hematopoietic 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

Article. 10.1038/s41409-023-02012-5. 2023

  • Open Access.

Mismatched Unrelated Donor Transplantation with Ptcy-Based Gvhd Prophylaxis Is Associated with Better Survival Than Double Unit Umbilical Cord Blood Transplantation in Patients with AML in First CR: A Study from the ALWP of the EBMT

Baron, Frederic; (...); Ciceri, Fabio

Meeting Abstract. 10.1182/blood-2023-186293. 2023

  • Open Access.

Multicenter Long-Term Follow-Up of Allogeneic Hematopoietic Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials.

Lin, Chenyu; (...); Horwitz, Mitchell E.

Article. 10.1016/j.jtct.2023.01.031. 2023

  • Open Access.

MULTINATIONAL STUDY ASSESSING TREATMENT PATTERNS, OUTCOMES, AND HEALTHCARE RESOURCE UTILIZATION IN HEMATOPOIETIC STEM CELL TRANSPLANT RECIPIENTS WITH REFRACTORY/RESISTANT CYTOMEGALOVIRUS INFECTION, OR INTOLERANCE TO ANTI-CYTOMEGALOVIRUS THERAPIES

Papanicolaou, Genovefa; (...); Hirji, Ishan

Meeting Abstract. 2023


MUTATIONAL PROFILE ENABLES THE IDENTIFICATION OF A HIGH RISK SUBGROUP IN MYELODYSPLASTIC SYNDROMES WITH ISOLATED TRISOMY 8

Toribio Castello, S. M.; (...); Del Rey, M.

Meeting Abstract. 10.1016/j.leukres.2023.107189. 2023


Mutational Profile Enables the Identification of a High-Risk Subgroup in Myelodysplastic Syndromes with Isolated Trisomy 8.

Toribio-Castelló S; (...); Hernández-Rivas JM

Article. 10.3390/cancers15153822. 2023

  • Open Access.

Mutually-Exclusive Pathways between IKZF1 plus and RAS Mutations and TP53 double-Hit Alterations Lead Relapse in B-Other, Ph-like and Hyperdiploidy Genetic Groups in Adult B- Cell Acute Lymphoblastic Leukemia

Navas Acosta, Josgrey Del Valle Del Valle; (...); Hernandez-Rivas, Jesus Maria

Meeting Abstract. 10.1182/blood-2023-182163. 2023

  • Open Access.

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

  • Open Access.

NEUROLOGIC COMPLICATIONS AFTER ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION WITH CALCINEURIN-FREE GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS

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

Meeting Abstract. 2023


NLRP3 inflammasome activation and symptom burden in KRAS-mutated CMML patients is reverted by IL-1 blocking therapy.

Hurtado-Navarro L; (...); Ferrer-Marín F

Article. 10.1016/j.xcrm.2023.101329. 2023

  • Open Access.

Non-T-depleted haploidentical transplantation with post-transplant cyclophosphamide in patients with secondary versus de novo AML in first complete remission: a study from the ALWP/EBMT.

Nagler, Arnon; (...); Mohty, Mohamad

Article. 10.1186/s13045-023-01450-4. 2023

  • Open Access.

Non-T-depleted haploidentical transplantation with post-transplant cyclophosphamide in patients with secondary versus de novo AML in first complete remission: a study from the ALWP/EBMT (16, 58, 2023)

Nagler, Arnon; (...); Mohty, Mohamad

Correction. 10.1186/s13045-023-01501-w. 2023

  • Open Access.

Non-traumatic spontaneous abdominal haemorrhage

Ballesta, M.; (...); Lerga, P. Estelles

Article. 10.1016/j.rx.2022.11.003. 2023


Non-traumatic spontaneous abdominal haemorrhage.

Ballesta M; (...); Estellés Lerga P

Article. 10.1016/j.rxeng.2022.11.004. 2023


Obecabtagene Autoleucel (obe-cel, AUTO1) for Relapsed/Refractory Adult B-cell Acute Lymphoblastic Leukemia (R/R B-ALL): Pooled Analysis of the Ongoing FELIX Phase Ib/II Study

Roddie, Claire; (...); Jabbour, Elias

Meeting Abstract. 10.1182/blood-2023-179454. 2023

  • Open Access.

Objective Image Quality Comparison Between Brain-Dedicated PET and PET/CT Scanners.

Gandia-Ferrero MT; (...); Martí-Bonmatí L

Article. 10.1007/s10916-023-01984-7. 2023


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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

Omicron SARS-CoV-2 infection management and outcomes in patients with hematologic disease and recipients of cell therapy.

Pinana, Jose Luis; (...); Solano, Carlos

Article. 10.3389/fonc.2024.1389345. 2024

  • Open Access.

Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Review. 10.3390/biology12091159. 2023

  • Open Access.

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

  • Open Access.

Outcome of Allogeneic Stem Cell Transplantation in FLT3-TKD-Mutated AML - a Study on Behalf of the Acute Leukemia Working Party of the EBMT

Heinicke, Thomas; (...); Mohty, Mohamad

Meeting Abstract. 10.1182/blood-2023-174233. 2023

  • Open Access.

Outcomes and effect of somatic mutations after erythropoiesis stimulating agents in patients with lower-risk myelodysplastic syndromes.

Caballero, Juan Carlos; (...); Diez Campelo, Maria

Article. 10.1177/20406207231218157. 2024

  • Open Access.

Outcomes for patients with EBV-positive PTLD post-allogeneic HCT after failure of rituximab-containing therapy

Socie, Gerard; (...); Mohty, Mohamad

Article. 10.1038/s41409-023-02127-9. 2024

  • Open Access.

Outcomes of CAR-T Cell Therapy for Large B Cell Lymphoma in Patients of 70 Years and Older: Multicentric Experience on Behalf of Geth-TC/Geltamo

Bailen, Rebeca; (...); Barba, Pere

Meeting Abstract. 10.1182/blood-2023-185858. 2023

  • Open Access.

OUTCOMES OF CAR-T CELL THERAPY FOR LARGE B CELL LYMPHOMA IN PATIENTS OF 70 YEARS AND OLDER: MULTICENTRIC REAL WORLD EXPERIENCE

Bailen, Rebeca; (...); Barba, Pere

Meeting Abstract. 2023


Outcomes of graft failure after umbilical cord blood transplantation in acute leukemia: a study from Eurocord and the Acute Leukemia Working Party of the EBMT.

Baron F; (...); Mohty M

Article. 10.1038/s41409-023-02000-9. 2023


Pilot Inter-Laboratory Comparison Study of Optical Genome Mapping Analysis for Cytogenomic Characterization of Hematological Malignancies: A Spanish Multicentric Study

Puiggros, Anna; (...); Espinet, Blanca

Meeting Abstract. 10.1182/blood-2022-166293. 2022

  • Open Access.

POST-TRANSPLANT CYCLOPHOSPHAMIDE (PTCY) VERSUS ANTI-THYMOCYTE GLOBULIN (ATG) VERSUS COMBINATION FOR GRAFT-VERSUS-HOST DISEASE PREVENTION IN HAPLOIDENTICAL TRANSPLANTATION FOR ADULT ACUTE MYELOID LEUKEMIA: A REPORT FROM THE EBMT

Bazarbachi, Abdul-Hamid; (...); Mohty, Mohamad

Meeting Abstract. 2023


Posttransplant cyclophosphamide versus antithymocyte globulin in patients with acute lymphoblastic leukemia treated with allogeneic hematopoietic cell transplantation from matched unrelated donors. A study from the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation.

Giebel, Sebastian; (...); Mohty, Mohamad

Article. 10.1002/cncr.35004. 2023


Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in HLAMatched and Haploidentical Donor Transplants for Patients with Hodgkin disease: A Comparative Study of the LWP EBMT

Montoro, Juan; (...); Glass, Bertram

Meeting Abstract. 10.1182/blood-2023-179829. 2023

  • Open Access.

Post-Transplantation Cyclophosphamide-Based Graft-versus-Host Disease Prophylaxis in HLA-Matched and Haploidentical Donor Transplantation for Patients with Hodgkin Lymphoma: A Comparative Study of the Lymphoma Working Party of the European Society for Blood and Marrow Transplantation.

Montoro, Juan; (...); Glass, Bertram

Article. 10.1016/j.jtct.2023.11.021. 2024

  • Open Access.

Practice Patterns of Transplant Centers Regarding Maintenance Treatment Post Allogeneic Hematopoietic Cell Transplantation in Acute Myeloid Leukemia: A Survey on Behalf of the EBMT Acute Leukemia Working Party

Abou Dalle, Iman; (...); Mohty, Mohamad

Meeting Abstract. 10.1182/blood-2023-187095. 2023


Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services

Company Albir MJ, Poveda Andrés JL, Edo Solsona MD

Article. 10.1016/j.farma.2023.06.0131130. 2024

  • Open Access.

Pre-Transplant Somatic Co-Occurring Mutations (by next generation sequencing) in Acute Myeloid Leukemia: Frequency and Impact on Clinical Outcomes after Allogeneic Hematopoietic Cell Transplantation - a Large Study on Behalf of the EBMT Acute Leukemia Working Party

Bazarbachi, Ali; (...); Mohty, Mohamad

Meeting Abstract. 10.1182/blood-2023-182823. 2023


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


Rationale for combined therapies in severe-to-critical COVID-19 patients

Gonzaga, Aitor; (...); Soria, Bernat

Review. 10.3389/fimmu.2023.1232472. 2023

  • Open Access.

Real-World Experience in Extracorporeal photopheresisfor adults with graft-versus-host disease.

Asensi Cantó P; (...); Gómez-Seguí I

Article. 10.1016/j.jtct.2023.09.001. 2023

  • Open Access.

Recent advances in allogeneic transplantation for acute myeloid leukemia.

Montoro J, Balaguer-Roselló A, Sanz J

Article. 10.1097/CCO.0000000000000992. 2023

  • Open Access.

Reduced incidence of neurologic complications after allogeneic hematopoietic stem cell transplantation with calcineurin-free graft-versus-host disease prophylaxis.

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

Article. 10.1016/j.jtct.2023.07.008. 2023

  • Open Access.

Regions of homozygosity confer a worse prognostic impact in myelodysplastic syndrome with normal karyotype.

Mallo, Mar; (...); Sole, Francesc

Article. 10.1002/jha2.651. 2023

  • Open Access.

Relationship between neuroimaging and emotion recognition in Mild Cognitive Impairment patients.

Gandia-Ferrero, Maria Teresa; (...); Marti-Bonmati, Luis

Article. 10.1016/j.bbr.2023.114844. 2024


Remdesivir or Nirmatrelvir/Ritonavir Therapy for Omicron SARS-CoV-2 Infection in Hematological Patients and Cell Therapy Recipients

Pinana, Jose Luis; (...); Solano, Carlos

Article. 10.3390/v15102066. 2023

  • Open Access.

Respiratory virus infections after allogeneic stem cell transplantation: Current understanding, knowledge gaps, and recent advances.

Piñana JL; (...); Navarro D

Article. 10.1111/tid.14117. 2023

  • Open Access.

Role of allogeneic hematopoietic cell transplant for relapsed/refractory aggressive B-cell lymphomas in the CART era.

Mussetti, Alberto; (...); Sureda, Anna

Article. 10.1038/s41409-023-01949-x. 2023


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

  • Open Access.

Role of Allogeneic Stem Cell Transplantation in Preventing Relapse in Adult BCR::ABL1-like Acute Lymphoblastic Leukemia

Ribera, Jordi; (...); Ribera, Josep-Maria

Meeting Abstract. 10.1182/blood-2023-186265. 2023


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

  • Open Access.

Safety and efficacy of obecabtagene autoleucel (obe-cel, AUTO1), a fast-off rate CD19 CAR, in relapsed/refractory adult B-cell acute lymphoblastic leukemia (r/r B-ALL): Top line results of the pivotal FELIX study.

Roddie, Claire; (...); Jabbour, Elias

Meeting Abstract. 2023


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

  • Open Access.

SARS-CoV-2 Immunity in Hematopoietic Stem Cell Transplant and Cell Therapy Recipients: What Do We Know, and What Remains to Be Determined?

Pinana, Jose Luis, Guerreiro, Manuel, Solano, Carlos

Review. 10.3390/hemato4020014. 2023

  • Open Access.

SARS-CoV-2-reactive antibody waning, booster effect and breakthrough SARS-CoV-2 infection in hematopoietic stem cell transplant and cell therapy recipients at one year after vaccination.

Pinana, Jose Luis; (...); Solano, Carlos

Article. 10.1038/s41409-023-01946-0. 2023

  • Open Access.

Score to Guide Donor Choice in Haploidentical Stem Cell Transplant Using PostTransplant Cyclophosphamide for Patients with Acute Myeloid Leukemia: A Study from the Acute Leukemia Working Party of the EBMT

Sanz, Jaime; (...); Ciceri, Fabio

Meeting Abstract. 10.1182/blood-2023-180075. 2023


SECOND ALLOGENEIC STEM CELL TRANSPLANTATION (HSCT2) FOR PRIMARY GRAFT FAILURE IN PATIENTS WITH ACUTE LEUKEMIA IN REMISSION: ON BEHALF OF THE ALWP OF THE EBMT

Nagler, Arnon; (...); Mohty, Mohamad

Meeting Abstract. 2023


Sequential treatment of High-risk Neuroblastoma combining I-131 MIBG high-dose and Topotecan. First experience

Orrego, N.; (...); Bello-Arques, P.

Meeting Abstract. 2023


Significance of Degree of HLA Disparity Using T-cell Replete Peripheral Blood Stem Cells From Haploidentical Donors With Posttransplantation Cyclophosphamide in AML in First Complete Hematologic Remission: A Study of the Acute Leukemia Working Party of the EBMT.

Kharfan-Dabaja, Mohamed A.; (...); Mohty, Mohamad

Article. 10.1097/HS9.0000000000000920. 2023

  • Open Access.

Starkeya nomas sp. nov., a prosthecate and budding bacterium isolated from an immunocompromized patient.

Sahuquillo-Arce JM; (...); López-Hontangas JL

Article. 10.1099/ijsem.0.005805. 2023


T REPLETE HAPLOIDENTICAL TRANSPLANTATION WITH POSTTRANSPLANT CYCLOPHOSPHAMIDE IN PATIENTS WITH SECONDARY VERSUS DE NOVO AML: A STUDY FROM THE ALWP /EBMT

Nagler, Arnon; (...); Mohty, Mohamad

Meeting Abstract. 2023


T-cell Depleted Peripheral Blood versus Unmanipulated Bone Marrow in Matched Sibling Transplantation for Aplastic Anemia.

Chorao, Pedro; (...); Sanz, Jaime

Article. 10.1016/j.jtct.2023.01.016. 2023

  • Open Access.

The Clinical Spectrum, Diagnosis, and Management of GATA2 Deficiency.

Santiago, Marta; (...); Cervera, Jose

Article. 10.3390/cancers15051590. 2023

  • Open Access.

The Impact of DNMT3A Mutation on Survival of AML Patients Receiving Allogeneic Hematopoietic Cell Transplantation in First Remission Depends on the Karyotype and CoOccurring Mutations: On Behalf of the EBMT Acute Leukemia Working Party

Dalle, Abou; (...); Mohty, Mohamad

Meeting Abstract. 10.1182/blood-2023-179531. 2023

  • Open Access.

The Post-CAR Prognostic Index (PC-PI): A New Prognostic Score to Predict Overall Survival in Large B-Cell Lymphoma Patients Progressing after Chimeric Antigen Receptor T-Cell Therapy

Lacoboni, Gloria; (...); Abrisqueta Costa, Pau

Meeting Abstract. 10.1182/blood-2023-184942. 2023

  • Open Access.

The prognostic impact of non-driver gene mutations and variant allele frequency in primary myelofibrosis

Hernandez-Sanchez, Alberto; (...); Hernandez-Boluda, Juan Carlos

Letter. 10.1002/ajh.27203. 2024

  • Open Access.

Thiotepa-Based Regimens Are Valid Alternatives to Total Body Irradiation-Based Reduced-Intensity Conditioning Regimens in Patients with Acute Lymphoblastic Leukemia: A Retrospective Study on Behalf of the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation.

Battipaglia, Giorgia; (...); Mohty, Mohamad

Article. 10.1016/j.jtct.2023.09.028. 2024

  • Open Access.

Torque Teno Virus plasma DNA load: a novel prognostic biomarker in CAR-T therapy

Benzaquen, Ana; (...); Solano, Carlos

Article. 10.1038/s41409-023-02114-0. 2024

  • Open Access.

TORQUE TENO VIRUS PLASMA DNA LOAD: A NOVEL PROGNOSTIC BIOMARKER IN CAR-T THERAPY

Hernani, Rafael; (...); Solano, Carlos

Meeting Abstract. 2023


TP53 ALLELIC STATE DID NOT INFLUENCE THE PROGNOSIS IN MYELODYSPLASTIC SYNDROMES (MDS) WITH 5Q DELETION

Montoro, M. J.; (...); Valcarcel, D.

Meeting Abstract. 10.1016/j.leukres.2023.107187. 2023


TP53 Allelic State in Myelodysplastic Syndromes with 5q Deletion

Montoro Gomez, Maria Julia; (...); Valcarcel, David

Meeting Abstract. 10.1182/blood-2022-165257. 2022

  • Open Access.

TP53 Gene allelic State in Myelodysplastic Syndromes (MDS) with Isolated 5q Deletion

Montoro, Julia; (...); Valcarcel, David

Meeting Abstract. 10.1182/blood-2023-179171. 2023

  • Open Access.

Transfusion Burden in Allogeneic Hematopoietic Stem Cell Transplantation over Time: Experience from a Single Institution.

Solves, Pilar; (...); Sanz, Jaime

Article. 10.3390/jcm12103467. 2023

  • Open Access.

Unrelated or haploidentical allogeneic hematopoietic cell transplantation in second complete remission for acute myeloid leukemia-Improved outcomes over time: A European Society for Blood and Marrow Transplantation Acute Leukemia Working Party study.

Al Hamed, Rama; (...); Mohty, Mohamad

Article. 10.1002/cncr.34843. 2023

  • Open Access.

Upper and/or Lower Respiratory Tract Infection Caused by Human Metapneumovirus After Allogeneic Hematopoietic Stem Cell Transplantation.

Piñana JL; (...); de la Camara, Rafael

Article. 10.1093/infdis/jiad268. 2024

  • Open Access.

Use of optical genome mapping in the cytogenetic diagnosis of multiple myeloma

de la Rubia, Javier; (...); Such, Esperanza

Meeting Abstract. 2023


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


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