Pagani

Researchers are conducting a large prospective, observational cohort study to assess the clinical impact of new monoclonal antibodies (MAB) in treating B-cell Non-Hodgkin Lymphoma (NHL) within Italian clinical practice. The study focuses on patients needing treatment for B-cell NHL, including those receiving first-line or relapsed/refractory therapy. The novel MAB being studied have received approval from the European Medicines Agency (EMA) since 2020 and are prescribed according to authorized marketing indications in Italy. Participants will receive novel MAB treatments either alone or in combination, prescribed based on EMA-approved indications since 2020. Patients will be grouped into cohorts according to the treatment indication, antibody type, and lymphoma subtype, with additional sub-cohorts created if necessary. This design allows analysis by indication, antibody type, subtype, and overall evaluation of the entire patient cohort. Throughout the study, researchers will collect clinical information to evaluate the use, feasibility, efficacy, and toxicity of these novel antibodies. Key outcomes measured over at least five years include overall response rate, complete response rate, progression-free survival, overall survival, event-free survival, time to next treatment, non-relapse mortality, duration of response, and incidence of early and late adverse events. Participants will be closely monitored for both short- and long-term effects of the treatments.

Researchers are evaluating how well sonrotoclax combined with obinutuzumab or rituximab compares to venetoclax plus rituximab in treating adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This phase 3, open-label study will also assess the safety of these treatment combinations. The study is sponsored by BeOne Medicines, previously known as BeiGene, and involves multiple centers. Participants will receive one of the following treatments: sonrotoclax taken orally with intravenous obinutuzumab, sonrotoclax taken orally with intravenous rituximab, or venetoclax taken orally with intravenous rituximab. The treatments are given according to the study protocol, and participants are randomly assigned to one of these groups. The study monitors how these combinations work over time. During the study, participants will be regularly assessed through evaluations such as imaging, laboratory tests, and physical exams to monitor disease progression and treatment effects. Researchers will measure progression-free survival, which is how long participants live without disease worsening, with follow-up lasting up to about 51 months. Safety is also closely monitored to understand any side effects. The total duration of participation depends on the individual treatment and follow-up schedules.

Researchers are conducting an open-label, randomized, multicenter phase III study to evaluate the feasibility of allogeneic stem cell transplantation (HSCT) in patients with higher-risk myelodysplastic syndromes (HR-MDS). The study compares two approaches: hypomethylating therapy (HMT) followed by HSCT versus HSCT upfront in patients with less than 10% bone marrow blasts, and conventional chemotherapy (CHT) versus HMT followed by HSCT in patients with more than 10% bone marrow blasts. This non-inferiority trial aims to assess which treatment strategy is more feasible based on the proportion of patients who successfully receive HSCT over four years. Participants receive treatments based on their bone marrow blast counts. Those with under 10% blasts receive azacitidine, administered as 75 mg/m2 subcutaneously daily for 7 days every 28 days, followed by HSCT or HSCT upfront. Patients with more than 10% blasts are treated with standard chemotherapy consisting of two cycles of intravenous induction and consolidation therapy using cytarabine and daunorubicin before HSCT. The study compares these treatment regimens to determine the best sequence for transplantation. During the study, participants are closely monitored for treatment feasibility, including assessments of successful HSCT receipt. Researchers evaluate outcomes over a four-year period, focusing on the proportion of patients completing the transplantation process. Patients must meet specific health criteria and provide informed consent. Safety and treatment adherence are observed throughout the trial, ensuring comprehensive data on the transplantation strategies in HR-MDS patients aged 18 to 70 years.

Researchers are evaluating the addition of gemtuzumab ozogamicin to standard chemotherapy to reduce minimal residual disease (MRD) levels in adults aged 18 to 60 with favorable or intermediate-risk acute myeloid leukemia (AML) who have not been previously treated. This phase 3 study focuses on patients with de novo AML, excluding certain subtypes and mutations, to see if MRD-driven post-remission therapy, such as autologous or allogeneic stem cell transplant, improves anti-leukemic outcomes. Participants will receive induction and consolidation chemotherapy combining gemtuzumab ozogamicin with daunorubicin and cytarabine. The treatment aims to lower MRD before transplant and guide risk assignment for subsequent therapy intensity. The study is conducted at multiple centers and targets patients with specific AML risk profiles, excluding those with prior chemotherapy (except limited hydroxyurea use) or radiotherapy. During the study, patients will be closely monitored for MRD levels, along with assessments of organ function and overall health status. Primary outcomes include achieving MRD negativity within two months. Safety evaluations and follow-up will track treatment effects, adherence, and patient response. The study duration and detailed follow-up schedules are determined by the protocol to ensure comprehensive evaluation of treatment impact.

Researchers are evaluating the safety and effectiveness of a combination therapy of tucatinib, trastuzumab, and capecitabine in women with HER2-positive metastatic breast cancer. This study focuses on patients who have progressed after at least two prior anti-HER2 treatments and aims to observe how this treatment performs in a real-world clinical setting following approved indications and dosing guidelines. Tucatinib is an oral, highly selective HER2 tyrosine kinase inhibitor that has received regulatory approval based on previous trials demonstrating improved progression-free and overall survival in this patient population, including those with brain metastases. Patients will receive tucatinib in combination with trastuzumab and capecitabine according to their treating clinician's usual practice without additional treatment procedures imposed by the study. The study is observational and non-interventional, enrolling about 300 women who meet the treatment criteria. Data collection includes baseline characteristics, safety monitoring, and performance status evaluations during the period of tucatinib-based treatment. The study continues with a follow-up period lasting 18 months after treatment ends to monitor responses, survival, and any subsequent therapies. During participation, patients will undergo assessments including symptomatic response and best response evaluations by their clinicians following local practice. Safety and treatment effectiveness will be monitored throughout treatment and during the extended follow-up. Radiological and clinical data will be collected, and prior or subsequent treatments will be recorded to help understand the real-world impact of this therapy. The total observation time spans the treatment duration plus 18 months of follow-up to ensure comprehensive safety and efficacy evaluation.

Researchers are evaluating the impact of a healthy lifestyle-based Survivorship Care Plan (LS-SCP) on the quality of life in long-term lymphoma survivors who have been in remission for at least 3 years and up to 10 years. This prospective, randomized, open-label, multicenter study includes adults aged 18 to 50 who were treated for classical Hodgkin lymphoma (cHL), Diffuse Large B-cell lymphoma (DLBCL), or Primary mediastinal large B-cell lymphoma (PMBCL). The study aims to assess how lifestyle changes influence the quality of life in these survivors. Participants are divided into two groups: the experimental group receives the LS-SCP intervention, which includes a Survivorship Care Plan, nutritional guidance, and physical activity, all followed for 6 months. Compliance in this group is monitored through bi-monthly automatic calls. The control group receives usual follow-up care without any specific lifestyle intervention. Both groups complete validated questionnaires and clinical assessments at the start, and then at 6 and 12 months after randomization. During the study, participants complete several quality of life and health-related questionnaires and undergo clinical evaluations at baseline, 6 months, and 12 months. The study measures global quality of life over a period of up to 30 months. Researchers track adherence to the intervention through regular calls in the experimental group and monitor all participants for safety and health outcomes through follow-up visits and questionnaires.

Researchers are studying advanced follicular lymphoma (FL) to better understand the role of EZH2 gene changes in patients treated with immunochemotherapy. This study is linked to the FIL_FOLL12 trial and aims to find useful biomarkers that can help doctors decide the best chemotherapy combined with anti-CD20 immunotherapy for first-time treatment of advanced FL. The study also explores other new biological markers related to FL. The study involves testing for EZH2 mutations and copy number alterations using a special PCR method on blood and bone marrow samples collected at the start. Additionally, gene expression related to EZH2 will be measured in some tumor tissue samples. These tests help characterize the biological features of the lymphoma and its variations. Participants have already been enrolled in the FIL_FOLL12 trial, and their biological samples such as bone marrow, blood, and tumor tissue are used for these tests. Researchers will analyze these samples to assess progression-free survival up to 43 months from treatment start. The study seeks to provide rapid and practical biomarker results to improve treatment decisions for patients with advanced FL.

Researchers are conducting an open-label, multicenter, randomized phase III trial to compare two treatment approaches in elderly patients aged 65 and older with Diffuse Large B-Cell Lymphoma (DLBCL) or Follicular grade IIIb lymphoma. The study evaluates the addition of vitamin D supplementation to a standard prephase treatment with oral prednisone, followed by six cycles of immunochemotherapy with either R-CHOP or R-miniCHOP. The study aims to explore the effects of vitamin D supplementation during immunochemotherapy in this patient population, with a focus on progression-free survival over 54 months. Participants are randomly assigned in a 1 to 1 ratio to either the standard arm (Arm A) or the experimental arm (Arm B). Both arms receive a prephase of oral prednisone for 7 days followed by six 21-day cycles of immunochemotherapy with R-CHOP or R-miniCHOP. Patients in Arm B also receive vitamin D3 (cholecalciferol) supplementation starting with a loading dose based on baseline vitamin D levels, followed by weekly maintenance doses throughout immunochemotherapy and the option to continue monthly supplementation for up to two years. Adjustments to vincristine dosing during prephase and immunochemotherapy are allowed based on clinical judgement. Throughout the study, participants undergo baseline assessments and regular monitoring including vitamin D levels, treatment toxicity, and response evaluations. Patients experiencing treatment-related delays longer than four weeks discontinue study treatment but continue survival follow-up. The primary outcome measure is progression-free survival assessed at the end of treatment and up to 54 months. The study also includes safety monitoring and long-term follow-up to assess sustained outcomes and adverse events.

Primary Cardiac Lymphoma (PCL) is a rare type of lymphoma that affects only the heart and sometimes the pericardium. It represents about 2% of primary cardiac tumors and 0.5% of extranodal lymphomas. This condition is more common in males and usually presents with heart-related symptoms. The most frequent form is Diffuse Large B Cell Lymphoma (DLBCL). Historically, patients with PCL have had poor outcomes, but survival has improved in recent years. Due to its rarity, there is limited information and few studies have focused on a consistent group of patients, making some aspects of the disease and its management unclear. This study collects information from patients in Italy diagnosed with PCL between January 1, 2000, and December 31, 2020. It focuses on those treated for the first time with chemoimmunotherapy regimens that include an anti-CD20 monoclonal antibody, such as R-CHOP or similar treatments. The study aims to provide a better understanding of PCL by reviewing patient experiences and treatment outcomes across multiple centers. Participants will be monitored for overall survival, with data collection scheduled to end in the fourth quarter of 2023. Researchers will evaluate survival outcomes within two months after data collection ends. Throughout the study, patient information such as diagnosis details and treatment history will be reviewed to help clarify unknown aspects of PCL and improve future management approaches.

Researchers are investigating treatments for patients with relapsed or refractory Hodgkin's lymphoma who are candidates for autologous stem-cell transplantation (ASCT). The study includes a phase I portion to determine the maximum tolerated dose (MTD) of atezolizumab when combined with the BEGEV chemotherapy regimen, followed by a phase IIb randomized controlled trial comparing BEGEV alone versus BEGEV combined with atezolizumab. The goal is to assess safety, response rates, and the potential benefits of adding atezolizumab to the standard treatment. In phase I, 6 to 18 patients receive atezolizumab plus BEGEV every three weeks for four cycles. Those without significant toxicity or disease progression after two cycles undergo stem cell mobilization with additional cycles of A-BEGEV plus granulocyte colony-stimulating factor, followed by high-dose therapy and ASCT. Patients who achieve complete response after ASCT receive consolidation therapy with atezolizumab every four weeks for six doses, with possible adjuvant radiotherapy if not previously treated. In phase IIb, 122 patients are randomized into two arms: one receiving BEGEV followed by ASCT, and the other receiving atezolizumab plus BEGEV followed by ASCT and consolidation with atezolizumab. Participants will be closely monitored throughout induction, consolidation, and follow-up phases, including assessment of adverse events, disease status, survival, and long-term toxicities. Follow-up lasts for 18 months after the last patient's treatment, with evaluations every six months to better understand long-term outcomes and patient prognosis. This comprehensive approach aims to clarify the safety and efficacy of combining atezolizumab with BEGEV chemotherapy in this patient population.