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Article ; Online: Real-world experience with CPX-351 in high-risk acute myeloid leukemia.

Lemoli, Roberto M / Montesinos, Pau / Jain, Akriti

2023 Volume 185, Page(s) 103984

Abstract: CPX-351, a dual-drug liposomal encapsulation of daunorubicin/cytarabine, was approved for newly diagnosed therapy-related acute myeloid leukemia (AML) and AML with myelodysplasia-related changes in adults in 2017 (US; updated to patients aged ≥1 year in ... ...

Abstract	CPX-351, a dual-drug liposomal encapsulation of daunorubicin/cytarabine, was approved for newly diagnosed therapy-related acute myeloid leukemia (AML) and AML with myelodysplasia-related changes in adults in 2017 (US; updated to patients aged ≥1 year in 2021) and 2018 (EU/UK) based on improved survival and remission and comparable safety versus 7 + 3 chemotherapy in a randomized trial in older adults. Real-world studies have since evaluated CPX-351 in routine practice across several countries and addressed important data gaps (e.g., use in younger adults, measurable residual disease negativity, outcomes by mutation). This review discusses real-world studies of CPX-351 as AML treatment, with the aim of helping prescribers make informed treatment decisions.
MeSH term(s)	Humans ; Aged ; Daunorubicin/therapeutic use ; Leukemia, Myeloid, Acute/drug therapy ; Cytarabine/therapeutic use ; Liposomes/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/adverse effects
Chemical Substances	CPX-351 ; Daunorubicin (ZS7284E0ZP) ; Cytarabine (04079A1RDZ) ; Liposomes
Language	English
Publishing date	2023-04-05
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	605680-5
ISSN	1879-0461 ; 0737-9587 ; 1040-8428
ISSN (online)	1879-0461
ISSN	0737-9587 ; 1040-8428
DOI	10.1016/j.critrevonc.2023.103984
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Article: Literature review and expert opinion on the treatment of high-risk acute myeloid leukemia in patients who are eligible for intensive chemotherapy.

Palmieri, Raffaele / Billio, Atto / Ferrara, Felicetto / Galimberti, Sara / Lemoli, Roberto M / Todisco, Elisabetta / Moretti, Federico / Venditti, Adriano

Frontiers in oncology

2024 Volume 14, Page(s) 1367393

Abstract: In patients with Acute Myeloid Leukemia (AML), the assessment of disease risk plays a central role in the era of personalized medicine. Indeed, integrating baseline clinical and biological features on a case-by-case basis is not only essential to select ... ...

Abstract	In patients with Acute Myeloid Leukemia (AML), the assessment of disease risk plays a central role in the era of personalized medicine. Indeed, integrating baseline clinical and biological features on a case-by-case basis is not only essential to select which treatment would likely result in a higher probability of achieving complete remission, but also to dynamically customize any subsequent therapeutic intervention. For young high-risk patients with low comorbidities burden and in good general conditions (also called "fit" patients), intensive chemotherapy followed by allogeneic stem cell transplantation still represents the backbone of any therapeutic program. However, with the approval of novel promising agents in both the induction/consolidation and the maintenance setting, the algorithms for the management of AML patients considered eligible for intensive chemotherapy are in constant evolution. In this view, we selected burning issues regarding the identification and management of high-risk AML, aiming to provide practical advice to facilitate their daily clinical management in patients considered eligible for intensive chemotherapy.
Language	English
Publishing date	2024-02-20
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2024.1367393
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Article: Measurable Residual Disease in High-Risk Acute Myeloid Leukemia.

Cluzeau, Thomas / Lemoli, Roberto M / McCloskey, James / Cooper, Todd

Cancers

2022 Volume 14, Issue 5

Abstract: Mounting evidence suggests measurable residual disease (MRD) assessments are prognostic in acute myeloid leukemia (AML). High-risk AML encompasses a subset of AML with poor response to therapy and prognosis, with features such as therapy-related AML, an ... ...

Abstract	Mounting evidence suggests measurable residual disease (MRD) assessments are prognostic in acute myeloid leukemia (AML). High-risk AML encompasses a subset of AML with poor response to therapy and prognosis, with features such as therapy-related AML, an antecedent hematologic disorder, extramedullary disease (in adults), and selected mutations and cytogenetic abnormalities. Historically, few patients with high-risk AML achieved deep and durable remission with conventional chemotherapy; however, newer agents might be more effective in achieving MRD-negative remission. CPX-351 (dual-drug liposomal encapsulation of daunorubicin/cytarabine at a synergistic ratio) demonstrated MRD-negativity rates of 36-64% across retrospective studies in adults with newly diagnosed high-risk AML and 84% in pediatric patients with first-relapse AML. Venetoclax (BCL2 inhibitor) demonstrated MRD-negativity rates of 33-53% in combination with hypomethylating agents for high-risk subgroups in studies of older adults with newly diagnosed AML who were ineligible for intensive therapy and 65% in combination with chemotherapy in pediatric patients with relapsed/refractory AML. However, there is no consensus on optimal MRD methodology in AML, and the use of different techniques, sample sources, sensitivity thresholds, and the timing of assessments limit comparisons across studies. Robust MRD analyses are needed in future clinical studies, and MRD monitoring should become a routine aspect of AML management.
Language	English
Publishing date	2022-03-01
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers14051278
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Article ; Online: New strategies for stem cell mobilization.

Lemoli, Roberto M

Mediterranean journal of hematology and infectious diseases

2012 Volume 4, Issue 1, Page(s) e2012066

Abstract: Mobilized peripheral blood (PB) is widely used as source of stem cells (PBSCs) for autologous stem cell transplantation (ASCT). The use of cytokines, alone or in combination with chemotherapy (chemomobilization), is the most common strategy applied to ... ...

Abstract	Mobilized peripheral blood (PB) is widely used as source of stem cells (PBSCs) for autologous stem cell transplantation (ASCT). The use of cytokines, alone or in combination with chemotherapy (chemomobilization), is the most common strategy applied to mobilize and collect PBSCs. However, a significant proportion of cancer patients fail to mobilize enough PBSCs to proceed to ASCT. Plerixafor is a small molecule that reversibly and transiently disrupts the interaction between the chemokine receptor CXCR4 and its ligand CXCL12 (formerly known as stroma derived factor 1, SDF-1) leading to the rapid release of CD34(+) hematopoietic stem cells from the bone marrow (BM) to PB. Plerixafor has been recently approved to enhance PBSC mobilization in adult patients with multiple myeloma or non-Hodgkin lymphoma and has been shown to be more effective than G-CSF alone. There is limited experience on combining plerixafor with chemotherapy plus G-CSF in patients who mobilize poorly. Current evidence suggests that the addition of plerixafor is safe and effective in the large majority of the patients with low blood CD34(+) cell count after mobilization and/or poor yield after the first collection(s). Circulating CD34(+) cells can be increased by several folds with plerixafor and the majority of the patients considered "poor mobilizers" can be successfully collected. Overall, its mechanism of action inducing the rapid release of CD34(+) cells from the BM to the circulation makes plerixafor suitable for the 'preemptive' use in patients who are hard-to-mobilize.
Language	English
Publishing date	2012-10-03
Publishing country	Italy
Document type	Journal Article
ZDB-ID	2674750-9
ISSN	2035-3006 ; 2035-3006
ISSN (online)	2035-3006
ISSN	2035-3006
DOI	10.4084/MJHID.2012.066
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Article ; Online: Targeting the deacetylase SIRT6 unveils spliceosome deregulation as exploitable vulnerability for aggressive myeloma.

Gelli, Elisa / Soncini, Debora / Becherini, Pamela / Martinuzzi, Claudia / Todoerti, Katia / Cagnetta, Antonia / Aquino, Sara / Guolo, Fabio / Miglino, Maurizio / Bruzzone, Santina / Nencioni, Alessio / Neri, Antonino / Lemoli, Roberto M / Cea, Michele

Blood advances

2023 Volume 7, Issue 14, Page(s) 3472–3478

MeSH term(s)	Humans ; Spliceosomes/genetics ; Multiple Myeloma/genetics ; Sirtuins
Chemical Substances	Sirtuins (EC 3.5.1.-) ; SIRT6 protein, human (EC 3.5.1.-)
Language	English
Publishing date	2023-03-09
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2915908-8
ISSN	2473-9537 ; 2473-9529
ISSN (online)	2473-9537
ISSN	2473-9529
DOI	10.1182/bloodadvances.2022009035
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Article: Daratumumab in the treatment of C3 glomerulopathy with monoclonal gammopathy: a case report and literature review.

Esposito, Pasquale / Picciotto, Daniela / Costigliolo, Francesca / Russo, Elisa / Macciò, Lucia / Cenacchi, Giovanna / Cagnetta, Antonia / Cea, Michele / Lemoli, Roberto M / Viazzi, Francesca

Frontiers in medicine

2023 Volume 10, Page(s) 1266172

Abstract: Although rare, C3 glomerulopathy (C3G) is increasingly recognized thanks to the currently available diagnostic skills. C3G is not a single disease but a group of disorders with distinct pathogenesis and progression. Thus, an essential step for its ... ...

Abstract	Although rare, C3 glomerulopathy (C3G) is increasingly recognized thanks to the currently available diagnostic skills. C3G is not a single disease but a group of disorders with distinct pathogenesis and progression. Thus, an essential step for its management remains an in-depth characterization of the specific form and the identification of underlying conditions, which may also impact treatment choices as well. Among these entities, an emerging condition is the association of C3G with monoclonal gammopathy, which confers poor outcomes. Overall, diagnosis of C3G remains challenging, and determining the appropriate treatment remains unclear. Conventional immunosuppressive therapy has proven ineffective in such cases, while clone-directed therapies have shown promising results in small interventional studies and case series. Here, we report a case of a patient affected by C3G with monoclonal gammopathy of renal significance who experienced rapid deterioration of kidney function requiring replacement therapy. After the failure of first-line treatment, a switch to the anti-CD38 therapy with daratumumab resulted in the progressive improvement of the patient's kidney function, leading to the discontinuation of hemodialysis after approximately 10 months. Serial renal biopsies were also performed to study the disease's evolution in response to the treatment. Based on the description of this single case, we have comprehensively reviewed available studies on daratumumab use in patients with C3G associated with monoclonal gammopathy to provide insights for the design of prospective studies which aim to enhance the management of such poor prognosis disease.
Language	English
Publishing date	2023-09-01
Publishing country	Switzerland
Document type	Case Reports
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2023.1266172
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Article: Fluorescence-guided laparoscopic lymph node biopsy in a lymphoma patient: a possible new clinical application of indocyanine green.

Casaccia, Marco / Testa, Tommaso / Martigli, Sofia Paola / Santoliquido, Matteo / Lemoli, Roberto Massimo

Journal of surgical case reports

2022 Volume 2022, Issue 3, Page(s) rjac047

Abstract: To date, there are no reports indicating the use of indocyanine green (ICG) fluorescence to detect pathologic lymphatic tissue when a laparoscopic lymph node biopsy (LLB) for suspected new or recurrent lymphoma is performed. We present the case of a 72- ... ...

Abstract	To date, there are no reports indicating the use of indocyanine green (ICG) fluorescence to detect pathologic lymphatic tissue when a laparoscopic lymph node biopsy (LLB) for suspected new or recurrent lymphoma is performed. We present the case of a 72-year-old female patient admitted for suspicion of recurrent lymphoma. A preoperative imaging work-up showed solid tissue enveloping the terminal portion of the abdominal aorta with a standardized uptake value (SUV) of 10. Therefore, an LLB was planned. After induction of anesthesia, a ICG solution was injected intravenously and subcutaneously at both inguinal regions. At laparoscopy, a complete visualization of the pathologic lymph nodes was achieved, enabling an incisional biopsy of the lymphomatous mass. LLB with ICG-fluorescence offers a simple and safe method for pathologic lymph node detection in the suspicion of intra-abdominal lymphoma. More studies with large case series are needed to confirm the efficacy of this application.
Language	English
Publishing date	2022-03-09
Publishing country	England
Document type	Case Reports
ZDB-ID	2580919-2
ISSN	2042-8812
ISSN	2042-8812
DOI	10.1093/jscr/rjac047
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Article ; Online: Novel strategies of adoptive immunotherapy: How natural killer cells may change the treatment of elderly patients with acute myeloblastic leukemia.

Lemoli, Roberto M / Parisi, Sarah / Curti, Antonio

Experimental hematology

2017 Volume 45, Page(s) 10–16

Abstract: Although many attempts have been made to identify novel molecular-targeted therapies for patients with acute myeloid leukemia, their translation into the clinic have had limited impact. In particular, the question of effective and curative treatments for ...

Abstract	Although many attempts have been made to identify novel molecular-targeted therapies for patients with acute myeloid leukemia, their translation into the clinic have had limited impact. In particular, the question of effective and curative treatments for elderly patients, who are not eligible for stem cell transplantation, remains an unmet medical need. To answer this question, a wide range of immunologic therapeutic strategies, mostly T cell based, have been proposed and investigated. At present, however, the clinical results have been largely unsatisfactory. Natural killer cells have recently been used as a means of adoptive immunotherapy with promising clinical results. On the basis of recent clinical reports and moving from the basic immunobiology of natural killer cells, here we discuss some open issues in the clinical translation of natural killer-based adoptive immunotherapy for the management of elderly patients with acute myeloid leukemia.
MeSH term(s)	Age Factors ; Aged ; Animals ; Disease Management ; Graft vs Host Disease/etiology ; Humans ; Immunotherapy, Adoptive/adverse effects ; Immunotherapy, Adoptive/methods ; Killer Cells, Natural/immunology ; Killer Cells, Natural/metabolism ; Leukemia, Myeloid, Acute/diagnosis ; Leukemia, Myeloid, Acute/immunology ; Leukemia, Myeloid, Acute/mortality ; Leukemia, Myeloid, Acute/therapy ; Recurrence ; T-Lymphocyte Subsets/immunology ; T-Lymphocyte Subsets/metabolism ; Tissue Donors ; Treatment Outcome
Language	English
Publishing date	2017-01
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	185107-x
ISSN	1873-2399 ; 0531-5573 ; 0301-472X
ISSN (online)	1873-2399
ISSN	0531-5573 ; 0301-472X
DOI	10.1016/j.exphem.2016.10.007
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Article ; Online: Process development and validation of expanded regulatory T cells for prospective applications: an example of manufacturing a personalized advanced therapy medicinal product.

Lavazza, Cristiana / Budelli, Silvia / Montelatici, Elisa / Viganò, Mariele / Ulbar, Francesca / Catani, Lucia / Cannone, Marta Giulia / Savelli, Sara / Groppelli, Elisa / Lazzari, Lorenza / Lemoli, Roberto M / Cescon, Matteo / La Manna, Gaetano / Giordano, Rosaria / Montemurro, Tiziana

Journal of translational medicine

2022 Volume 20, Issue 1, Page(s) 14

Abstract: Background: A growing number of clinical trials have shown that regulatory T (T: Results: The GMP-compliant protocol defined in this work allows at least 4.11 × 10: Conclusions: These results could be of great use for facilities implementing GMP- ... ...

Abstract	Background: A growing number of clinical trials have shown that regulatory T (T Results: The GMP-compliant protocol defined in this work allows at least 4.11 × 10 Conclusions: These results could be of great use for facilities implementing GMP-compliant cell therapy protocols of these cells for different conditions aimed at restoring the T
MeSH term(s)	Cell- and Tissue-Based Therapy ; Graft vs Host Disease ; Humans ; Immune Tolerance ; Prospective Studies ; T-Lymphocytes, Regulatory
Language	English
Publishing date	2022-01-05
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2118570-0
ISSN	1479-5876 ; 1479-5876
ISSN (online)	1479-5876
ISSN	1479-5876
DOI	10.1186/s12967-021-03200-x
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Article ; Online: Donor selection for adoptive immunotherapy with NK cells in AML patients: Comparison between analysis of lytic NK cell clones and phenotypical identification of alloreactive NK cell repertoire.

Meazza, Raffaella / Ruggeri, Loredana / Guolo, Fabio / Minetto, Paola / Canevali, Paolo / Loiacono, Fabrizio / Ciardelli, Sara / Bo, Alessandra / Luchetti, Silvia / Serio, Alberto / Zannoni, Letizia / Retière, Christelle / Colomar-Carando, Natalia / Parisi, Sarah / Curti, Antonio / Lemoli, Roberto M / Pende, Daniela

Frontiers in immunology

2023 Volume 14, Page(s) 1111419

Abstract: Natural killer (NK) cell-based adoptive immunotherapy in leukemia patients is an emerging field of interest based on clinical evidence of efficacy and safety. Elderly acute myeloid leukemia (AML) patients have been successfully treated with NK cells from ...

Abstract	Natural killer (NK) cell-based adoptive immunotherapy in leukemia patients is an emerging field of interest based on clinical evidence of efficacy and safety. Elderly acute myeloid leukemia (AML) patients have been successfully treated with NK cells from HLA-haploidentical donors, especially when high amounts of alloreactive NK cells were infused. The aim of this study was comparing two approaches to define the size of alloreactive NK cells in haploidentical donors for AML patients recruited in two clinical trials with the acronym "NK-AML" (NCT03955848), and "MRD-NK". The standard methodology was based on the frequency of NK cell clones capable of lysing the related patient-derived cells. The alternative approach consisted of the phenotypic identification of freshly derived NK cells expressing, as inhibitory receptors, only the inhibitory KIR(s) specific for the mismatched KIR-Ligand(s) (HLA-C1, HLA-C2, HLA-Bw4). However, in KIR2DS2
MeSH term(s)	Aged ; Humans ; Donor Selection ; Leukocytes, Mononuclear ; Immunotherapy, Adoptive ; Reproducibility of Results ; Leukemia, Myeloid, Acute/therapy ; Killer Cells, Natural ; Clone Cells
Language	English
Publishing date	2023-02-14
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.2023.1111419
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