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Article: A New Algorithm Integrating Molecular Response, Toxicity, and Plasma Level Measures for Ponatinib Dose Choice in Patients Affected by Chronic Myeloid Leukemia.

Galimberti, Sara / Abruzzese, Elisabetta / Luci, Giacomo / Baratè, Claudia / Luciano, Luigia / Iurlo, Alessandra / Caocci, Giovanni / Morganti, Riccardo / Stefanelli, Fabio / Di Paolo, Antonello

Pharmaceutics

2024 Volume 16, Issue 3

Abstract: Ponatinib may be effective in chronic myeloid leukemia (CML) patients after failure of first/second line therapies. Although its efficacy for minimum plasma concentrations ( ... ...

Abstract	Ponatinib may be effective in chronic myeloid leukemia (CML) patients after failure of first/second line therapies. Although its efficacy for minimum plasma concentrations (C
Language	English
Publishing date	2024-03-11
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527217-2
ISSN	1999-4923
ISSN	1999-4923
DOI	10.3390/pharmaceutics16030383
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Article ; Online: Induction of neutralizing antibodies in CLL patients after SARS-CoV-2 mRNA vaccination: a monocentric experience.

Baratè, Claudia / Caruso, Teresita / Mavilia, Fabrizio / Sammuri, Paola / Pratesi, Federico / Motta, Giuseppe / Guerri, Valentina / Galimberti, Sara / Migliorini, Paola

Clinical and experimental medicine

2022 Volume 23, Issue 4, Page(s) 1197–1203

Abstract: Vaccination represents the best strategy to fight COVID-19 pandemics, especially in immune compromised subjects. In chronic lymphatic leukemia patients, a marked impairment of the immune response to mRNA SARS-CoV-2 vaccine was observed. In this report, ... ...

Abstract	Vaccination represents the best strategy to fight COVID-19 pandemics, especially in immune compromised subjects. In chronic lymphatic leukemia patients, a marked impairment of the immune response to mRNA SARS-CoV-2 vaccine was observed. In this report, we analyzed anti-RBD and neutralizing antibodies in CLL patients after two doses of mRNA SARS CoV 2 vaccine and evaluated the impact of Bruton kinase inhibitory agents. Twenty-seven CLL patients vaccinated with mRNA vaccines against SARS CoV-2 were recruited. Serum IgG, IgM and IgA anti-RBD antibodies and neutralizing antibodies were detected, and antibody avidity was measured. Peripheral blood leukocytes subsets were evaluated by flow cytometry. After two vaccine doses anti-RBD IgG were produced in 11/27 (40.5%) of patients and levels of IgG and IgA anti RBD in CLL patients were sensibly lower than in controls. Neutralizing antibodies were detectable in 12/27 (44.5%) of the patients and their level was lower than that observed in controls. Disease burden and treatment with Bruton kinases inhibitors markedly impaired vaccine induced antibody response. However, in responder patients, antibody avidity was comparable to normal subjects, indicating that the process of clonal selection and affinity maturation takes place as expected. Taken together, these data confirm the impact of disease burden and therapy on production of anti-RBD and neutralizing antibodies and support the current policy of vaccinating CLL patients.
MeSH term(s)	Humans ; Leukemia, Lymphocytic, Chronic, B-Cell ; Antibodies, Neutralizing ; COVID-19 Vaccines ; SARS-CoV-2 ; COVID-19/prevention & control ; Vaccination ; Immunoglobulin A ; Immunoglobulin G
Chemical Substances	Antibodies, Neutralizing ; COVID-19 Vaccines ; Immunoglobulin A ; Immunoglobulin G
Language	English
Publishing date	2022-09-08
Publishing country	Italy
Document type	Journal Article
ZDB-ID	2053018-3
ISSN	1591-9528 ; 1591-8890
ISSN (online)	1591-9528
ISSN	1591-8890
DOI	10.1007/s10238-022-00877-2
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Article: Relapsed/Refractory Chronic Lymphocytic Leukemia Patients Treated with Fixed Duration Venetoclax-Rituximab: Assessment of Response with Ultrasound, and Relationship with Minimal Residual Disease.

Benedetti, Edoardo / Baratè, Claudia / Mavilia, Fabrizio / Bramanti, Emilia / Morganti, Riccardo / Guerri, Valentina / Cervetti, Giulia / Capochiani, Enrico / Bertaggia, Ilaria / Stella, Salvatore Massimo / Traverso, Ginevra / Bruno, Benedetto / Galimberti, Sara

Journal of clinical medicine

2023 Volume 12, Issue 5

Abstract: A fixed duration of venetoclax-rituximab (VenR) resulted in a significant benefit of both PFS and in the attainment of an undetectable minimal residual disease (uMRD) compared with bendamustine-rituximab in relapsed/refractory (R/R) chronic lymphocytic ... ...

Abstract	A fixed duration of venetoclax-rituximab (VenR) resulted in a significant benefit of both PFS and in the attainment of an undetectable minimal residual disease (uMRD) compared with bendamustine-rituximab in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) patients. The 2018 International Workshop on CLL guidelines, outside the context of clinical trials, suggested ultrasonography (US) as a possible imaging technique to evaluate visceral involvement, and palpation to evaluate superficial lymph nodes (SupLNs). In this real-life study we prospectively enrolled N = 22 patients. Patients were assessed by US, to determine nodal and splenic response in R/R CLL patients treated with a fixed duration VenR. We found an overall response rate, complete remission, partial remission, and stable disease, of 95.4%, 68%, 27.3%, and 4.5%, respectively. Responses were also correlated with risk categories. The time to response, and the time to clearance of the disease in the spleen, in abdominal LN (AbdLNs), and in SupLNs were discussed. Responses were independent from LN size. The correlation between response rate with MRD were also investigated. US allowed to detect a substantial CR rate correlated with uMRD.
Language	English
Publishing date	2023-02-23
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662592-1
ISSN	2077-0383
ISSN	2077-0383
DOI	10.3390/jcm12051772
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Article ; Online: Mutational Profile in 75 Patients With Anti-Myelin-Associated Glycoprotein Neuropathy: Clinical and Hematologic Therapy Response and Hints on New Therapeutic Targets.

Castellani, Francesca / Visentin, Andrea / Schirinzi, Erika / Salvalaggio, Alessandro / Cacciavillani, Mario / Candiotto, Cinzia / Baratè, Claudia / Cellini, Alessandro / Bertorelle, Roberta / Siciliano, Gabriele / Trentin, Livio / Briani, Chiara

Neurology(R) neuroimmunology & neuroinflammation

2023 Volume 10, Issue 4

Abstract: Background and objectives: Neuropathy with antibodies to myelin-associated glycoprotein (MAG) is the most common paraproteinemic IgM neuropathy. Recently, the mutational profile of the : Methods: Seventy-five patients (47 men, mean age at molecular ... ...

Abstract	Background and objectives: Neuropathy with antibodies to myelin-associated glycoprotein (MAG) is the most common paraproteinemic IgM neuropathy. Recently, the mutational profile of the Methods: Seventy-five patients (47 men, mean age at molecular analysis 70.8 ± 10.2 years; mean disease duration 5.1 ± 4.9 years) with anti-MAG antibody neuropathy were recruited. Among them, 38 (50.7%) had IgM monoclonal gammopathy of undetermined significance, 29 (38.7%) Waldenstrom macroglobulinemia (WM), and 8 (10.6%) chronic lymphocytic leukemia/marginal zone lymphoma/hairy cell leukemia variant. Molecular analysis was performed on DNA from the bone marrow mononuclear cells in 55 of 75 patients and from peripheral mononuclear cells in 18 of 75 patients. Forty-five patients were treated with rituximab, 6 with ibrutinib, 2 with obinutuzumab-chlorambucil, and 3 with venetoclax-based therapy. All the patients were assessed with the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale, INCAT Sensory Sum Score, and MRC Sum Score at baseline and follow-up. We considered as responders, patients who improved by at least 1 point in 2 clinical scales. Results: Fifty patients (66.7%) carried the Discussion: MYD88
MeSH term(s)	Aged ; Aged, 80 and over ; Humans ; Male ; Middle Aged ; Autoantibodies ; Glycoproteins ; Immunoglobulin M ; Myeloid Differentiation Factor 88/genetics ; Peripheral Nervous System Diseases/drug therapy ; Peripheral Nervous System Diseases/genetics ; Rituximab/therapeutic use ; Waldenstrom Macroglobulinemia/drug therapy ; Female
Chemical Substances	Autoantibodies ; Glycoproteins ; Immunoglobulin M ; Myeloid Differentiation Factor 88 ; Rituximab (4F4X42SYQ6)
Language	English
Publishing date	2023-05-03
Publishing country	United States
Document type	Journal Article
ZDB-ID	2767740-0
ISSN	2332-7812 ; 2332-7812
ISSN (online)	2332-7812
ISSN	2332-7812
DOI	10.1212/NXI.0000000000200122
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Article ; Online: Real-life diagnostic and therapeutic approach to CLL: a 2022 update from an expert panel in Tuscany.

Baratè, Claudia / Sanna, Alessandro / Benedetti, Edoardo / Bocchia, Monica / Capochiani, Enrico / Danesi, Romano / Moretti, Sabrina / Occhini, Ubaldo / Santini, Simone / Galimberti, Sara / Gozzetti, Alessandro

Clinical and experimental medicine

2023 Volume 23, Issue 8, Page(s) 4251–4264

Abstract: A panel of chronic lymphocytic leukemia (CLL) experts from Tuscany propose a real-life diagnostic and therapeutic approach CLL that considers the role of genomic and somatic prognostic factors in risk stratification and treatment decisions. Safety and ... ...

Abstract	A panel of chronic lymphocytic leukemia (CLL) experts from Tuscany propose a real-life diagnostic and therapeutic approach CLL that considers the role of genomic and somatic prognostic factors in risk stratification and treatment decisions. Safety and efficacy of new agents has been demonstrated now not only in clinical trials but also in many real-world series. The BTK inhibitors, ibrutinib and acalabrutinib, and BH3 mimetic venetoclax are now indicated as first-line therapy and chemoimmunotherapy can be spared to the majority of CLL patients, thus preventing unnecessary hematological and non-hematological toxicity and second primary tumors. For treatment, FISH for 17 p and P53 mutational status are essential. IGHV mutation can be done at diagnosis or before treatment. Echography is the gold standard radiological investigation in CLL, at both diagnosis and response evaluation. Chemotherapy is virtually abandoned. Age, genetic risk, and patient comorbidities have to be carefully evaluated for treatment decision. With the availability of different drugs, there is a need for a uniform and shared approach in daily therapeutic choice. The proposed approach is based on current evidence and guidelines as well as results from clinical trials and daily clinical experience.
MeSH term(s)	Humans ; Leukemia, Lymphocytic, Chronic, B-Cell/diagnosis ; Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy ; Leukemia, Lymphocytic, Chronic, B-Cell/genetics ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Immunotherapy ; Risk Factors
Language	English
Publishing date	2023-11-18
Publishing country	Italy
Document type	Journal Article ; Review
ZDB-ID	2053018-3
ISSN	1591-9528 ; 1591-8890
ISSN (online)	1591-9528
ISSN	1591-8890
DOI	10.1007/s10238-023-01244-5
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Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
Jg. 1995 - 2021: Lesesall (2.OG)
ab Jg. 2022: Lesesaal (EG)

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Article: Mechanisms Underlying the Anti-inflammatory and Immunosuppressive Activity of Ruxolitinib.

Elli, Elena Maria / Baratè, Claudia / Mendicino, Francesco / Palandri, Francesca / Palumbo, Giuseppe Alberto

Frontiers in oncology

2019 Volume 9, Page(s) 1186

Abstract: The JAK-STAT signaling pathway plays a central role in signal transduction in hematopoietic cells, as well as in cells of the immune system. The occurrence in most patients affected by myeloproliferative neoplasms (MPNs) of driver mutations resulting in ... ...

Abstract	The JAK-STAT signaling pathway plays a central role in signal transduction in hematopoietic cells, as well as in cells of the immune system. The occurrence in most patients affected by myeloproliferative neoplasms (MPNs) of driver mutations resulting in the constitutive activation of JAK2-dependent signaling identified the deregulated JAK-STAT signal transduction pathway as the major pathogenic mechanism of MPNs. It also prompted the development of targeted drugs for MPNs. Ruxolitinib is a potent and selective oral inhibitor of both JAK2 and JAK1 protein kinases. Its use in patients with myelofibrosis is associated with a substantial reduction in spleen volume, attenuation of symptoms and decreased mortality. With growing clinical experience, concerns about infectious complications, and increased risk of B-cell lymphoma, presumably caused by the effects of JAK1/2 inhibition on immune response and immunosurveillance, have been raised. Evidence shows that ruxolitinib exerts potent anti-inflammatory and immunosuppressive effects. Cellular targets of ruxolitinib include various components of both the innate and adaptive immune system, such as natural killer cells, dendritic cells, T helper, and regulatory T cells. On the other hand, immunomodulatory properties have proven beneficial in some instances, as highlighted by the successful use of ruxolitinib in corticosteroid-resistant graft vs. host disease. The objective of this article is to provide an overview of published evidence addressing the key question of the mechanisms underlying ruxolitinib-induced immunosuppression.
Language	English
Publishing date	2019-11-07
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2019.01186
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Article: Monitoring Chronic Myeloid Leukemia: How Molecular Tools May Drive Therapeutic Approaches.

Izzo, Barbara / Gottardi, Enrico Marco / Errichiello, Santa / Daraio, Filomena / Baratè, Claudia / Galimberti, Sara

Frontiers in oncology

2019 Volume 9, Page(s) 833

Abstract: More than 15 years ago, imatinib entered into the clinical practice as a "magic bullet"; from that point on, the prognosis of patients affected by chronic myeloid leukemia (CML) became comparable to that of aged-matched healthy subjects. The aims of ... ...

Abstract	More than 15 years ago, imatinib entered into the clinical practice as a "magic bullet"; from that point on, the prognosis of patients affected by chronic myeloid leukemia (CML) became comparable to that of aged-matched healthy subjects. The aims of treatment with tyrosine kinase inhibitors (TKIs) are for complete hematological response after 3 months of treatment, complete cytogenetic response after 6 months, and a reduction of the molecular disease of at least 3 logs after 12 months. Patients who do not reach their goal can switch to another TKI. Thus, the molecular monitoring of response is the main consideration of management of CML patients. Moreover, cases in deep and persistent molecular response can tempt the physician to interrupt treatment, and this "dream" is possible due to the quantitative PCR. After great international effort, today the BCR-ABL1 expression obtained in each laboratory is standardized and expressed as "international scale." This aim has been reached after the establishment of the EUTOS program (in Europe) and the LabNet network (in Italy), the platforms where biologists meet clinicians. In the field of quantitative PCR, the digital PCR is now a new and promising, sensitive and accurate tool. Some authors reported that digital PCR is able to better classify patients in precise "molecular classes," which could lead to a better identification of those cases that will benefit from the interruption of therapy. In addition, digital PCR can be used to identify a point mutation in the ABL1 domain, mutations that are often responsible for the TKI resistance. In the field of resistance, a prominent role is played by the NGS that enables identification of any mutation in ABL1 domain, even at sub-clonal levels. This manuscript reviews how the molecular tools can lead the management of CML patients, focusing on the more recent technical advances.
Language	English
Publishing date	2019-09-06
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2019.00833
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Article ; Online: Myeloproliferative and lymphoproliferative disorders: State of the art.

Rumi, Elisa / Baratè, Claudia / Benevolo, Giulia / Maffioli, Margherita / Ricco, Alessandra / Sant'Antonio, Emanuela

Hematological oncology

2019 Volume 38, Issue 2, Page(s) 121–128

Abstract: Myeloproliferative neoplasms (MPNs), including polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF), are clonal disorders complicated mainly by vascular events and transformation to myelofibrosis (for PV and ET) or ... ...

Abstract	Myeloproliferative neoplasms (MPNs), including polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF), are clonal disorders complicated mainly by vascular events and transformation to myelofibrosis (for PV and ET) or leukemia. Although secondary malignancies, in particular, lymphoproliferative disorders (LPNs), are rare, they occur at a higher frequency than found in the general population, and there has been recent scientific discussion regarding a hypothetical relationship between treatment with JAK inhibitors in MPN and the risk of development of LPN. This has prompted increased interest regarding the coexistence of MPN and LPN. This review focuses on the role of JAK2 and the JAK/STAT pathway in MPN and LPN, whether there is a role for the genetic background in the occurrence of both MPN and LPN and whether there is a role for cytoreductive drugs in the occurrence of both MPN and LPN. Furthermore, whether an increased risk of lymphoma development is limited to patients who receive the JAK inhibitor ruxolitinib, is a more general phenomenon that occurs following JAK1/2 inhibition or is associated with preferential JAK1 or JAK2 targeting is discussed.
MeSH term(s)	Humans ; Janus Kinase 1/antagonists & inhibitors ; Janus Kinase 1/genetics ; Janus Kinase 2/antagonists & inhibitors ; Janus Kinase 2/genetics ; Lymphoproliferative Disorders/complications ; Lymphoproliferative Disorders/drug therapy ; Lymphoproliferative Disorders/genetics ; Lymphoproliferative Disorders/pathology ; Mutation ; Myeloproliferative Disorders/complications ; Myeloproliferative Disorders/drug therapy ; Myeloproliferative Disorders/genetics ; Myeloproliferative Disorders/pathology ; Prognosis ; Protein Kinase Inhibitors/therapeutic use
Chemical Substances	Protein Kinase Inhibitors ; JAK1 protein, human (EC 2.7.10.2) ; JAK2 protein, human (EC 2.7.10.2) ; Janus Kinase 1 (EC 2.7.10.2) ; Janus Kinase 2 (EC 2.7.10.2)
Language	English
Publishing date	2019-12-27
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	604884-5
ISSN	1099-1069 ; 0278-0232
ISSN (online)	1099-1069
ISSN	0278-0232
DOI	10.1002/hon.2701
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Zs.A 1816: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
Jg. 1995 - 2021: Lesesall (1.OG)
ab Jg. 2022: Lesesaal (EG)

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Article ; Online: The third dose of mRNA SARS-CoV-2 vaccines enhances the spike-specific antibody and memory B cell response in myelofibrosis patients.

Fiorino, Fabio / Ciabattini, Annalisa / Sicuranza, Anna / Pastore, Gabiria / Santoni, Adele / Simoncelli, Martina / Polvere, Jacopo / Galimberti, Sara / Baratè, Claudia / Sammartano, Vincenzo / Montagnani, Francesca / Bocchia, Monica / Medaglini, Donata

Frontiers in immunology

2022 Volume 13, Page(s) 1017863

Abstract: Vaccination against SARS-CoV-2 using mRNA-based vaccines has been highly recommended for fragile subjects, including myelofibrosis patients (MF). Available data on the immune responsiveness of MF patients to mRNA SARS-CoV-2 vaccination, and the impact of ...

Abstract	Vaccination against SARS-CoV-2 using mRNA-based vaccines has been highly recommended for fragile subjects, including myelofibrosis patients (MF). Available data on the immune responsiveness of MF patients to mRNA SARS-CoV-2 vaccination, and the impact of the therapy with the JAK inhibitor ruxolitinib, are still fragmented. Here, we profile the spike-specific IgG and memory B-cell response in MF patients, treated or not with ruxolitinib, after the second and the third dose of SARS-CoV-2 BNT162b2 (BioNTech) and mRNA-1273 (Moderna) vaccines. Plasma and peripheral blood mononuclear cells samples were collected before vaccination, post the second and the third doses and tested for spike-specific antibodies, ACE2/RBD antibody inhibition binding activity and spike-specific B cells. The third vaccine dose significantly increased the spike-specific IgG titers in both ruxolitinib-treated and untreated patients, and strongly enhanced the percentage of subjects with antibodies capable of
MeSH term(s)	Angiotensin-Converting Enzyme 2 ; Antibodies, Viral ; BNT162 Vaccine ; COVID-19/prevention & control ; COVID-19 Vaccines ; Humans ; Immunoglobulin G ; Janus Kinase Inhibitors ; Leukocytes, Mononuclear ; Memory B Cells ; Nitriles ; Primary Myelofibrosis ; Pyrazoles ; Pyrimidines ; RNA, Messenger ; SARS-CoV-2 ; Spike Glycoprotein, Coronavirus/immunology ; Vaccines, Synthetic ; Viral Vaccines ; mRNA Vaccines
Chemical Substances	Antibodies, Viral ; COVID-19 Vaccines ; Immunoglobulin G ; Janus Kinase Inhibitors ; Nitriles ; Pyrazoles ; Pyrimidines ; RNA, Messenger ; Spike Glycoprotein, Coronavirus ; Vaccines, Synthetic ; Viral Vaccines ; mRNA Vaccines ; spike protein, SARS-CoV-2 ; ruxolitinib (82S8X8XX8H) ; Angiotensin-Converting Enzyme 2 (EC 3.4.17.23) ; BNT162 Vaccine (N38TVC63NU)
Language	English
Publishing date	2022-09-29
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2022.1017863
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Article: A Prospective Cross-Sectional Study on the Comparison of Ultrasound Assessment vs. Palpation in Chronic Lymphocytic Leukemia Patients in the Era of Targeted Therapy.

Benedetti, Edoardo / Mavilia, Fabrizio / Baratè, Claudia / Bramanti, Emilia / Morganti, Riccardo / Cervetti, Giulia / Capochiani, Enrico / Bruno, Benedetto / Pelosini, Matteo / Stella, Salvatore Massimo / Galimberti, Sara

Journal of clinical medicine

2022 Volume 11, Issue 11

Abstract: Background. In IWCLL guidelines, progressive splenomegaly and lymphadenopathy are signs of active disease. In this study, we have tested the hypotheses if US could be a reliable tool for both superficial lymphnodes (SupLNs) and splenic assessment in ... ...

Abstract	Background. In IWCLL guidelines, progressive splenomegaly and lymphadenopathy are signs of active disease. In this study, we have tested the hypotheses if US could be a reliable tool for both superficial lymphnodes (SupLNs) and splenic assessment in chronic lymphocytic leukemia (CLL) patients. Methods. We enrolled N = 75 patients. SupLN and the spleen were assessed by two independent physicians (M1 and M2) by palpation and by a third physician (M3) with ultrasound sonography (US) using two different sonographers (US1 and US2). The results of M1 vs. M2 assessment, US1 vs. US2, palpation vs. US were compared. The echostructure of N = 1037 SupLN and of the spleen was also investigated. Results. The dimensions of SupLNs assessed by MD1 vs. MD2 were statistically discordant. Splenic size was concordant. There was concordance between US1 and US2 SupLN and splenic assessment. US found a higher number of pathological SupLN (Cohen’s Kappa < 0.1) than palpation, which misses remarkable-sized SupLNs. LN echostructure and splenic involvement patterns were described. Conclusions. US is a reliable, radiation-free tool useful in clinical practice to assess SupLN and splenic involvement in CLL.
Language	English
Publishing date	2022-06-04
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662592-1
ISSN	2077-0383
ISSN	2077-0383
DOI	10.3390/jcm11113206
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