Barletta

Researchers are conducting a large prospective, observational cohort study to evaluate the clinical impact of new Monoclonal Antibodies MAB in patients with B-cell Non-Hodgkin Lymphoma NHL treated in Italian clinical practice. The study focuses on collecting information about the use, feasibility, effectiveness, and both short- and long-term side effects of novel MABs that have been approved by the European Medicines Agency since 2020 and prescribed according to authorized indications in Italy. Participants will be divided into groups based on treatment indication, antibody type, and lymphoma subtype to allow detailed analysis. The study observes patients with B-cell NHL who have received at least one dose of a novel MAB either alone or in combination, as authorized for use in Italy. Both patients receiving first-line treatment and those with relapsed or refractory disease are included. Various cohorts and sub-cohorts will be analyzed to understand outcomes by indication, antibody type, and histological subtype, providing a comprehensive overview of these treatments in real-life settings. Participants will be followed for at least five years to assess outcomes such as 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 the incidence of early and late adverse events. Clinical data collection will include treatment details, safety monitoring, and long-term follow-up to evaluate both effectiveness and toxicity. The study spans several years, allowing researchers to capture extensive real-world evidence on novel MAB use in B-cell NHL.

This research aims to evaluate financial toxicity FT in patients undergoing radiotherapy for various cancer types in Italy. Financial toxicity refers to the financial burden and distress patients may experience during cancer treatment. The study is observational and multicenter, focusing on assessing FT using the PROFFIT questionnaire, a validated tool designed specifically for Italian cancer patients. Researchers will also explore how changes in financial toxicity relate to quality of life, treatment side effects, and overall survival. Participants will complete the PROFFIT questionnaire, which consists of 16 items measuring financial toxicity and its possible causes. The questionnaire will be administered before starting radiotherapy, at the end of radiotherapy treatment, and during the first follow-up visit 1 to 2 months after treatment. Additional assessments include the EORTC QLQ-C30 questionnaire to measure quality of life and the PRO-CTCAE to evaluate treatment-related symptoms. The study compares financial toxicity across different groups based on cancer type, radiotherapy type, treatment, age, and sex. During the study, patients will be asked to complete questionnaires at specific time points baseline, end of radiotherapy, and first follow-up visit within 1 to 2 months post-treatment, with follow-up up to 12 months. Researchers will monitor financial toxicity scores and analyze how these relate to patients quality of life and treatment effects. Participation involves completing surveys and clinical monitoring without any experimental treatment. The study duration varies depending on individual follow-up schedules.

Researchers are evaluating the safety and effectiveness of tucatinib combined with trastuzumab and capecitabine in adult women with HER2-positive metastatic breast cancer in a real-world setting. This observational study includes patients who have previously received multiple HER2-targeted treatments and aims to understand how this combination therapy works outside of clinical trials. HER2 is a protein that promotes cancer cell growth and is overexpressed in about 20% of breast cancers. Tucatinib is an oral drug that selectively inhibits the HER2 protein, and this study follows approved treatment guidelines and doses. Patients will receive tucatinib, trastuzumab, and capecitabine as prescribed by their doctors according to local clinical practice without any additional treatment procedures mandated by the study. The study is non-interventional and multicenter, enrolling about 300 women who are candidates for tucatinib therapy, including those with prior treatments such as trastuzumab, pertuzumab, T-DM1, and T-DXd. Patients will be observed during their treatment period and followed for 18 months after finishing tucatinib therapy to monitor outcomes and safety. During the study, researchers will collect baseline data, safety information, and performance status using the Eastern Cooperative Oncology Group ECOG score. They will assess response to treatment and survival based on clinicians evaluations and local practice. Follow-up will include monitoring for symptoms, treatment response, and survival status for 18 months post-treatment. The study also records any treatments patients receive before or after tucatinib therapy to better understand its real-world effectiveness and safety.

Researchers are evaluating how a healthy lifestyle implemented through a Survivorship Care Plan LS-SCP may affect the quality of life for long-term lymphoma survivors who have been in remission for at least three years and up to ten years. The study focuses on patients with classical Hodgkin lymphoma, Diffuse Large B-cell lymphoma DLBCL, or Primary mediastinal large B-cell lymphoma PMBCL who have completed first-line therapy and are aged between 18 and 50 years. This randomized, open-label, multicenter trial aims to understand the impact of lifestyle changes on survivors well-being over time. Participants are randomly assigned to one of two groups the experimental arm receives a Survivorship Care Plan including a nutritional plan and physical activity guidance for six months, with bi-monthly automated calls to support adherence. The control arm receives no specific intervention and follows standard clinical care with self-administered questionnaires at 6 and 12 months. Both groups complete assessments using validated questionnaires at baseline, 6 months, and 12 months to evaluate various health and quality of life measures. During the study, participants undergo clinical assessments and complete questionnaires such as the EORTC QLQ-C30, SF12, MEDI-LITE, Chronic Fatigue Syndrome Self-assessment, Fatigue Assessment Scale, and Hospital Anxiety and Depression Scale. Researchers will monitor outcomes including global quality of life, psychosocial well-being, fatigue frequency, cognitive function, metabolic health, cardiovascular events, adherence to healthy behaviors, and overall survival for up to 30 months from study start. The study includes safety follow-up and compliance tracking to understand how lifestyle interventions might support long-term health in lymphoma survivors.

This research aims to evaluate the effects of adding Vitamin D supplementation to standard immunochemotherapy in elderly patients diagnosed with Diffuse Large B-Cell Lymphoma or Follicular grade IIIb lymphoma. This open-label, randomized phase III trial compares two treatment approaches to understand whether Vitamin D affects outcomes in patients aged 65 and older undergoing immunochemotherapy. Participants are randomly assigned to one of two groups. Both groups receive a prephase of oral prednisone followed by six cycles of immunochemotherapy with R-CHOP or R-miniCHOP every 21 days. The experimental group also receives Vitamin D supplementation starting before treatment and continuing through immunochemotherapy according to a set schedule, including loading doses based on baseline Vitamin D levels and weekly maintenance. Patients may continue Vitamin D supplementation after treatment for up to two years. During the study, participants undergo baseline assessments and are monitored regularly through the treatment cycles. Researchers track progression-free survival over 54 months as the primary outcome, along with overall survival, response rates, Vitamin D levels, physical functioning, and fatigue. Safety and treatment adherence are also monitored, with follow-up visits extending up to several years to evaluate long-term outcomes.

Researchers are evaluating the safety and effectiveness of combining atezolizumab with the BEGEV regimen as a first salvage treatment for patients with relapsed or refractory Hodgkins lymphoma who are candidates for autologous stem-cell transplantation ASCT. This study includes a phase I part to find the maximum tolerated dose MTD of atezolizumab when combined with BEGEV, and a phase IIb part to compare treatments with or without atezolizumab in a larger group of patients. The goal is to improve treatment responses and patient prognosis through this combined approach. In the phase I part, 6 to 18 patients will receive atezolizumab combined with the BEGEV regimen every 3 weeks for 4 cycles to determine the MTD. Patients without dose-limiting toxicity or disease progression will undergo stem cell mobilization with additional cycles of A-BEGEV and granulocyte colony-stimulating factor G-CSF, followed by myeloablative therapy and ASCT. In phase IIb, 122 patients will be randomized into two arms one receiving BEGEV alone followed by ASCT, and the other receiving atezolizumab plus BEGEV followed by ASCT and consolidation with six doses of atezolizumab every 4 weeks. Radiotherapy may also be planned based on clinical judgment. Participants will be monitored throughout the induction, consolidation, and follow-up phases for treatment response, safety, and side effects. Assessments include evaluating complete response rate before ASCT, overall response rates, stem cell mobilization, engraftment after ASCT, duration of response, progression-free survival, and overall survival. After the last treatment, all patients will enter a long-term follow-up for 18 months to track disease status, survival, secondary cancers, and late toxicities, with evaluations every 6 months until withdrawal, loss to follow-up, or death.

This observational study focuses on patients with head and neck squamous cell carcinoma HNSCC undergoing radical or adjuvant radiation therapy. Researchers aim to understand how vitamin D levels vary over time in these patients and how these levels relate to therapy side effects, disease outcomes, and toxicity. The study addresses gaps in current knowledge by prospectively evaluating vitamin Ds potential impact on treatment results and patient prognosis across multiple centers. Participants will be patients with confirmed non-metastatic locally advanced HNSCC who are candidates for bilateral neck irradiation as part of their radiation therapy. The study does not involve experimental treatments but follows patients as per standard clinical practice. Vitamin D levels will be measured at diagnosis and at various time points, including 4 and 7 weeks, to observe variations and possible links with treatment toxicity and disease response. During the study, researchers will collect data on vitamin D levels alongside monitoring radiotherapy side effects, treatment responses, relapse-free survival, and overall survival up to two years. Follow-up aligns with routine clinical care, and no additional interventions are given. The primary outcome is vitamin D variation at 7 weeks, with secondary outcomes including toxicity, response, and survival measures. Participants involvement mainly consists of blood tests and clinical evaluations conducted during their regular treatment visits.