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  1. Article: CAR-T Cell Therapy in B-Cell Acute Lymphoblastic Leukemia.

    Testa, Ugo / Sica, Simona / Pelosi, Elvira / Castelli, Germana / Leone, Giuseppe

    Mediterranean journal of hematology and infectious diseases

    2024  Volume 16, Issue 1, Page(s) e2024010

    Abstract: Treatment of refractory and relapsed (R/R) B acute lymphoblastic leukemia (B-ALL) is an unmet medical need in both children and adults. Studies carried out in the last two decades have shown that autologous T cells engineered to express a chimeric ... ...

    Abstract Treatment of refractory and relapsed (R/R) B acute lymphoblastic leukemia (B-ALL) is an unmet medical need in both children and adults. Studies carried out in the last two decades have shown that autologous T cells engineered to express a chimeric antigen receptor (CAR-T) represent an effective technique for treating these patients. Antigens expressed on B-cells, such as CD19, CD20, and CD22, represent targets suitable for treating patients with R/R B-ALL. CD19 CAR-T cells induce a high rate (80-90%) of complete remissions in both pediatric and adult R/R B-ALL patients. However, despite this impressive rate of responses, about half of responding patients relapse within 1-2 years after CAR-T cell therapy. Allo-HSCT after CAR-T cell therapy might consolidate the therapeutic efficacy of CAR-T and increase long-term outcomes; however, not all the studies that have adopted allo-HSCT as a consolidative treatment strategy have shown a benefit deriving from transplantation. For B-ALL patients who relapse early after allo-HSCT or those with insufficient T-cell numbers for an autologous approach, using T cells from the original stem cell donor offers the opportunity for the successful generation of CAR-T cells and for an effective therapeutic approach. Finally, recent studies have introduced allogeneic CAR-T cells generated from healthy donors or unmatched, which are opportunely manipulated with gene editing to reduce the risk of immunological incompatibility, with promising therapeutic effects.
    Language English
    Publishing date 2024-01-01
    Publishing country Italy
    Document type Journal Article ; Review
    ZDB-ID 2674750-9
    ISSN 2035-3006
    ISSN 2035-3006
    DOI 10.4084/MJHID.2024.010
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  2. Article: Editorial: The latest advances in transplantation for AML.

    Chiusolo, Patrizia / Ciceri, Fabio / Sica, Simona

    Frontiers in oncology

    2023  Volume 13, Page(s) 1189554

    Language English
    Publishing date 2023-04-05
    Publishing country Switzerland
    Document type Editorial
    ZDB-ID 2649216-7
    ISSN 2234-943X
    ISSN 2234-943X
    DOI 10.3389/fonc.2023.1189554
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  3. Article: Should the BCRA1/2-mutations healthy carriers be valid candidates for hematopoietic stem cell donation?

    Fresa, Alberto / Sica, Simona

    Hereditary cancer in clinical practice

    2021  Volume 19, Issue 1, Page(s) 22

    Abstract: It's still not clear whether the mutational status of BRCA-mutated healthy hematopoietic stem cells (HSCs) donors could have an impact on the engraftment. Comparing the studies present in literature, we focused on the correlation between BRCA mutations ... ...

    Abstract It's still not clear whether the mutational status of BRCA-mutated healthy hematopoietic stem cells (HSCs) donors could have an impact on the engraftment. Comparing the studies present in literature, we focused on the correlation between BRCA mutations and the development of hematological malignancies and Fanconi anemia (FA); then, we explored HSCs types, frequencies, and functions in the presence of BRCA mutations, as well as the reconstitution of hematopoiesis after chemotherapy and radiation treatments. The role of BRCA mutations in the FA showed a possible involvement in the onset of the disease; the mutation carriers, indeed, did not show any sign of the typical phenotype of the FA. BRCA mutational status can be considered as a risk factor for hematological malignancies, but only for secondary malignancies and/or in the presence of bone marrow stress factors. Currently we don't know if a conditioning regimen could be compensated by BRCA mutated HSCs, even if murine models tried to show the possible differences between fully mutated, haploinsufficient and normal HSCs. Thus, given the downregulating effect of the mutations on hematopoiesis, it could be questionable to use the HSCs of a BRCA-mutated donor in the presence of another available donor with the same compatibility.
    Language English
    Publishing date 2021-04-01
    Publishing country Poland
    Document type Journal Article ; Review
    ZDB-ID 2252512-9
    ISSN 1897-4287 ; 1731-2302
    ISSN (online) 1897-4287
    ISSN 1731-2302
    DOI 10.1186/s13053-021-00179-w
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  4. Article: FLT3 Mutated Acute Myeloid Leukemia after CD19 CAR-t Cells.

    Galli, Eugenio / Frioni, Filippo / Malara, Tanja / Attardi, Enrico / Bellesi, Silvia / Hohaus, Stefan / Sica, Simona / Sorà, Federica / Chiusolo, Patrizia

    Mediterranean journal of hematology and infectious diseases

    2024  Volume 16, Issue 1, Page(s) e2024029

    Language English
    Publishing date 2024-03-01
    Publishing country Italy
    Document type Journal Article
    ZDB-ID 2674750-9
    ISSN 2035-3006
    ISSN 2035-3006
    DOI 10.4084/MJHID.2024.029
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  5. Article: "Redo" 2D-3D Fusion Technique during Endovascular Redo Aortic Repair.

    Minelli, Fabrizio / Sica, Simona / Salman, Fadia / Donato, Federica / Dvir, May / Tshomba, Yamume / Tinelli, Giovanni

    Diagnostics (Basel, Switzerland)

    2023  Volume 13, Issue 4

    Abstract: Purpose: The present study aims to describe a new 2D-3D fusion registration method in the case of endovascular redo aortic repair and compare the accuracy of the registration using the previously implanted devices vs. bones as landmarks.: Materials ... ...

    Abstract Purpose: The present study aims to describe a new 2D-3D fusion registration method in the case of endovascular redo aortic repair and compare the accuracy of the registration using the previously implanted devices vs. bones as landmarks.
    Materials and methods: This single-center study prospectively analyzed all the patients that underwent elective endovascular re-interventions using the Redo Fusion technique between January 2016 and December 2021 at the Vascular Surgery Unit of the Fondazione Policlinico Universitario A. Gemelli (FPUG)-IRCCS in Rome, Italy. The fusion overlay was performed twice, first using bone landmarks (bone fusion) and the second using radiopaque markers of a previous endovascular device (redo fusion). The pre-operative 3D model was fused with live fluoroscopy to create a roadmap. Longitudinal distances between the inferior margin of the target vessel in live fluoroscopy and the inferior margin of the target vessel in bone fusion and redo fusion were measured.
    Results: This single-center study prospectively analyzed 20 patients. There were 15 men and five women, with a median age of 69.7 (IQR 42) years. The median distance between the inferior margin of the target vessel ostium in digital subtraction angiography and the inferior margin of the target vessel ostium in bone fusion and redo fusion was 5.35 mm and 1.35 mm, respectively (
    Conclusions: The redo fusion technique is accurate and allows the optimization of X-ray working views, supporting the endovascular navigation and vessel catheterization in case of endovascular redo aortic repair.
    Language English
    Publishing date 2023-02-08
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2662336-5
    ISSN 2075-4418
    ISSN 2075-4418
    DOI 10.3390/diagnostics13040635
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  6. Article ; Online: Haploidentical bone marrow transplants with post transplant cyclophosphamide on day + 3 + 5: The Genova protocol.

    Raiola, Anna Maria / Angelucci, Emanuele / Sica, Simona / Bacigalupo, Andrea

    Blood reviews

    2022  Volume 62, Page(s) 101031

    Abstract: We report 634 patients who underwent unmanipulated haploidentical (HAPLO) bone marrow transplantation (BMT) in two Centers. The diagnosis was acute myeloid leukemia (AML) (n = 251), acute lymphoblastic leukemia (ALL)(n = 107), myelodysplastic syndrome ... ...

    Abstract We report 634 patients who underwent unmanipulated haploidentical (HAPLO) bone marrow transplantation (BMT) in two Centers. The diagnosis was acute myeloid leukemia (AML) (n = 251), acute lymphoblastic leukemia (ALL)(n = 107), myelodysplastic syndrome and myelofibrosis (MDS + MF) (n = 125) and chronic lymphoproliferative disorders (n = 151). Median age was 52 years (16-74). Graft versus host disease (GvHD) prophylaxis was intravenous cyclosporin (CSA) starting on day 0, oral mycophenolate on day +1, and post-transplant cyclophosphamide (PTCY) on days +3 + 5. Primary graft failure was seen in 23 patients (3,6%); 17 /23 (74%) were rescued with second HAPLO graft, and were alive at one year. The cumulative incidence of acute GvHD grade II-IV was 29% and 3% for grade III-IV; the cumulative incidence of moderate severe chronic GvHD was 23%: older donor and patients age were significant predictors of both acute and chronic GvHD. The overall non relapse mortality (NRM) at 2 years was 19%: 8%, 21% and 30% in patients aged <40, 41-60 > 60 years. Disease free survival (DFS) at 5 years was 64% for acute leukemia in first remission, 51% for acute leukemia CR2, 25% for acute leukemia advanced disease and 49% for MDS/MPN. We confirm, on a relatively large number of patients, that unmanipulated HAPLO BMT with PTCY on days +3 + 5, mostly after a myeloablative conditioning regimen, is followed by a low incidence of graft failure and grade III-IV GvHD; moderate severe chronic GvHD is 23% and NRM at 2 years 19%; 5 year DFS is influenced by remission status of the underlying disease.
    MeSH term(s) Humans ; Middle Aged ; Bone Marrow Transplantation/adverse effects ; Bone Marrow Transplantation/methods ; Bone Marrow ; Cyclophosphamide/therapeutic use ; Leukemia, Myeloid, Acute/drug therapy ; Graft vs Host Disease/diagnosis ; Graft vs Host Disease/etiology ; Graft vs Host Disease/prevention & control ; Recurrence ; Transplantation Conditioning/methods ; Hematopoietic Stem Cell Transplantation/methods
    Chemical Substances Cyclophosphamide (8N3DW7272P)
    Language English
    Publishing date 2022-11-11
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 639015-8
    ISSN 1532-1681 ; 0268-960X
    ISSN (online) 1532-1681
    ISSN 0268-960X
    DOI 10.1016/j.blre.2022.101031
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    Zs.A 2207: Show issues Location:
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  7. Article ; Online: Targeting the undruggable: menin inhibitors ante portas.

    Dempke, Wolfram C M / Desole, Maximilian / Chiusolo, Patrizia / Sica, Simona / Schmidt-Hieber, Martin

    Journal of cancer research and clinical oncology

    2023  Volume 149, Issue 11, Page(s) 9451–9459

    Abstract: Acute myeloid leukaemias harbouring a rearrangement of the mixed lineage leukaemia gene (MLL) are aggressive haematopoietic malignancies that relapse early and have a poor prognosis (event-free survival less than 50%). Menin is a tumour suppressor, ... ...

    Abstract Acute myeloid leukaemias harbouring a rearrangement of the mixed lineage leukaemia gene (MLL) are aggressive haematopoietic malignancies that relapse early and have a poor prognosis (event-free survival less than 50%). Menin is a tumour suppressor, however, in MLL-rearranged leukaemias it functions as a co-factor which is mandatory for the leukaemic transformation by interaction with the N-terminal part of MLL, which is maintained in all MLL-fusion proteins. Inhibition of menin blocks leukaemogenesis and leads to differentiation and, in turn, to apoptosis of leukaemic blasts. Furthermore, nucleophosmin 1 (NPM1) binds to specific chromatin targets, which are co-occupied by MLL, and menin inhibition has been shown to trigger degradation of mNPM1 resulting in a rapid decrease in gene expression and activating histone modifications. Therefore, disruption of the menin-MLL axis blocks leukaemias driven by NPM1 mutations for which the expression of menin-MLL target genes (e.g., MEIS1, HOX etc.) is essential. To date at least six different menin-MLL inhibitors are undergoing clinical evaluation as first- and second-line monotherapy in acute leukaemias: DS-1594, BMF-219, JNJ-75276617, DSP-5336, revumenib, and ziftomenib, however, only for revumenib and ziftomenib early clinical data have been reported. In the revumenib phase I/II AUGMENT-101 trial (N = 68) with very heavily pretreated AML patients the ORR was 53% with a CR rate of 20%. The ORR in patients harbouring MLL rearrangement of mNPM1 was 59%. Patients who achieved a response had a mOS of 7 months. Similar results have been reported for ziftomenib in the phase I/II COMET-001 trial. ORR was 40% and CRc was 35% in AML patients with mNPM1. However, outcome was worse in AML patients with a MLL rearrangement (ORR 16.7%, CRc 11%). Differentiation syndrome was a notable adverse event. The clinical development of novel menin-MLL inhibitors is well in line with the currently ongoing paradigm shift towards targeted therapies seen in the AML treatment landscape. Moreover, the clinical assessment of combinations of these inhibitors with established therapy options in AML could be the fuel for an improved outcome of MLL/NPM1 patients.
    MeSH term(s) Humans ; Neoplasm Recurrence, Local ; Myeloid-Lymphoid Leukemia Protein/genetics ; Leukemia, Myeloid, Acute/drug therapy ; Leukemia, Myeloid, Acute/genetics ; Transcription Factors ; Nuclear Proteins/genetics
    Chemical Substances Myeloid-Lymphoid Leukemia Protein (149025-06-9) ; Transcription Factors ; Nuclear Proteins
    Language English
    Publishing date 2023-04-27
    Publishing country Germany
    Document type Journal Article ; Review
    ZDB-ID 134792-5
    ISSN 1432-1335 ; 0171-5216 ; 0084-5353 ; 0943-9382
    ISSN (online) 1432-1335
    ISSN 0171-5216 ; 0084-5353 ; 0943-9382
    DOI 10.1007/s00432-023-04752-9
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  8. Article ; Online: Spontaneous resolution of "therapy-related myelodysplasia" occurred after treatment with CAR-T cells: All that glitters is not gold.

    Frioni, Filippo / Galli, Eugenio / Sorà, Federica / Zini, Gina / Sica, Simona / Chiusolo, Patrizia

    International journal of laboratory hematology

    2023  Volume 45, Issue 5, Page(s) 810–812

    MeSH term(s) Humans ; Myelodysplastic Syndromes/therapy ; T-Lymphocytes
    Language English
    Publishing date 2023-05-24
    Publishing country England
    Document type Letter
    ZDB-ID 2268590-X
    ISSN 1751-553X ; 1751-5521 ; 0141-9854
    ISSN (online) 1751-553X
    ISSN 1751-5521 ; 0141-9854
    DOI 10.1111/ijlh.14099
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  9. Article ; Online: Complete aortic thrombosis in SARS-CoV-2 infection.

    Tinelli, Giovanni / Minelli, Fabrizio / Sica, Simona / Tshomba, Yamume

    European heart journal

    2021  Volume 42, Issue 23, Page(s) 2314

    MeSH term(s) Aortic Diseases/diagnostic imaging ; COVID-19 ; Humans ; SARS-CoV-2 ; Thrombosis/diagnostic imaging ; Thrombosis/etiology
    Language English
    Publishing date 2021-03-09
    Publishing country England
    Document type Journal Article
    ZDB-ID 603098-1
    ISSN 1522-9645 ; 0195-668X
    ISSN (online) 1522-9645
    ISSN 0195-668X
    DOI 10.1093/eurheartj/ehab011
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  10. Article ; Online: Vascular surgery education during COVID-19 pandemic.

    Tinelli, Giovanni / Sica, Simona / Minelli, Fabrizio / Tshomba, Yamume

    Journal of vascular surgery

    2020  Volume 72, Issue 2, Page(s) 763–764

    MeSH term(s) Betacoronavirus/pathogenicity ; COVID-19 ; Computer-Assisted Instruction/standards ; Coronavirus Infections/epidemiology ; Coronavirus Infections/prevention & control ; Coronavirus Infections/transmission ; Coronavirus Infections/virology ; Humans ; Infection Control/standards ; Internship and Residency/organization & administration ; Internship and Residency/standards ; Internship and Residency/statistics & numerical data ; Pandemics/prevention & control ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/prevention & control ; Pneumonia, Viral/transmission ; Pneumonia, Viral/virology ; SARS-CoV-2 ; Students, Medical/statistics & numerical data ; Surgeons/education ; Surgeons/organization & administration ; Surgeons/statistics & numerical data ; Surveys and Questionnaires/statistics & numerical data ; Vascular Surgical Procedures/education
    Keywords covid19
    Language English
    Publishing date 2020-05-11
    Publishing country United States
    Document type Letter
    ZDB-ID 605700-7
    ISSN 1097-6809 ; 0741-5214
    ISSN (online) 1097-6809
    ISSN 0741-5214
    DOI 10.1016/j.jvs.2020.04.496
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