Castelfranco Veneto

Researchers are investigating new treatments for advanced renal cell carcinoma RCC that has returned after prior therapy. The study aims to find out if the combination of belzutifan and zanzalintinib can help people with recurrent advanced RCC live longer without their cancer worsening compared to the drug cabozantinib. This is a phase 3 randomized trial evaluating these treatments in participants who have experienced recurrence during or after prior anti-PD-1L1 therapy. Participants are randomly assigned to receive either belzutifan plus zanzalintinib taken orally once daily or cabozantinib taken orally once daily. They continue their assigned treatment until certain reasons require stopping the study intervention. The study compares the effects of these treatments on cancer progression and survival among people with advanced RCC who have had disease recurrence after adjuvant therapy. During the study, participants will be regularly monitored for progression-free survival and overall survival for up to about 73 months. Researchers will also assess tumor response, duration of response, adverse events, and quality of life using questionnaires over approximately 25 months. The study involves ongoing evaluations to understand how these treatments affect symptoms, functioning, and overall health during long-term follow-up.

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.

Researchers are evaluating the safety and effectiveness of new treatments and combinations in adults with metastatic colorectal cancer CRC. This Phase II, global, open-label study includes a master protocol with substudies to test these treatments in participants who have not received prior systemic therapy for advanced disease and whose cancer is mismatch-repair-proficient pMMR or microsatellite stable MSS without liver metastases. Participants will be randomly assigned to one of two groups one receiving volrustomig combined with FOLFIRI a chemotherapy regimen of irinotecan, fluorouracil, and leucovorin plus bevacizumab, and the other receiving FOLFIRI plus bevacizumab alone. All treatments are given as intravenous infusions. The study aims to compare these combinations over approximately three years. During the trial, participants will undergo regular assessments including tumor measurements, safety monitoring through adverse event tracking, and laboratory tests. Researchers will evaluate progression-free survival, overall survival, response rates, and drug concentrations in the body. The study includes monitoring for immune responses and other side effects, with total participation lasting up to about three years.

Researchers are conducting a phase III randomized clinical trial to study early stage Follicular Lymphoma, a type of lymphoma that has not been treated before. The trial compares the effects of local Radiotherapy alone versus Radiotherapy combined with the drug Obinutuzumab. The goal is to better understand how these treatments work for patients with early stage Follicular Lymphoma and to evaluate progression-free survival and other outcomes. Participants will be randomly assigned to one of two groups one group will receive involved-site Radiotherapy at a standard dose of 24Gy alone the other group will receive the same Radiotherapy followed by Obinutuzumab infusionsfour weekly doses plus four additional doses every three weeks, totaling eight doses. This open-label study is conducted across multiple centers. During the study, participants will be monitored for treatment response and side effects over a period of up to 45 months, including 9 months of treatment and 36 months of follow-up. Assessments include imaging scans, laboratory tests, and molecular analyses to evaluate response rates, disease progression, and molecular markers. Safety and adverse events will be tracked throughout, with long-term follow-up to understand treatment effects and disease status.

This research aims to evaluate the real-life effectiveness, safety, and usage patterns of Octapharmas factor VIII FVIII concentratesNuwiq, Octanate, and Wilatein patients with severe haemophilia A who have either never been treated or have had minimal treatment. The study focuses on previously untreated patients, often young children, and minimally treated patients, gathering more data on treatment outcomes and inhibitor development to better understand optimal treatment approaches in routine clinical practice. Participants receive one of the three FVIII concentrates Nuwiq recombinant FVIII, Octanate plasma-derived FVIII, or Wilate plasma-derived FVIII combined with von Willebrand factor. The study observes how these products are used, including dosing and frequency, without altering prescribed treatments. This non-interventional study collects data during routine care to assess product utilization, safety, and effectiveness, including responses to surgical prophylaxis. During the study, researchers monitor participants for breakthrough bleeding rates and any adverse drug reactions over 100 exposure days to assess treatment effectiveness and safety. They also collect information on FVIII dosing and physicians evaluations of surgical prophylaxis effectiveness. The study involves patients of all ages and follows them through their usual clinical visits, with data gathered via observation rather than treatment changes. The study is designed to provide valuable real-world evidence on these FVIII concentrates in severe haemophilia A patients.

Researchers are investigating the relationship between MYC gene changes, lymphoma genetic mutations, and the immune environment in adults with Diffuse Large B-cell Lymphoma DLBCL or High-Grade B-cell Lymphoma HGBCL. These lymphomas are diverse diseases making up over a third of adult lymphomas, with survival rates of around 60-70% over five years. The study aims to better understand these genetic factors and their impact on disease outcomes to improve treatment approaches. This observational study includes patients diagnosed with DLBCL or HGBCL who have MYC gene rearrangements or increased MYC gene copies. Participants have received standard first-line chemotherapy treatments such as R-CHOP or intensified regimens. The study collects data retrospectively and prospectively to explore genetic markers, immune cell patterns, and clinical outcomes related to these MYC changes and other genetic alterations. Participants provide tissue samples and clinical information, which researchers analyze for genetic and histological features. The study evaluates how these factors relate to patient responses and survival over up to 36 months. Researchers also review treatment types, risk of disease recurrence, and the effectiveness of preventive therapies. The study spans from diagnosis after January 2019 through long-term follow-up, helping to identify potential prognostic and predictive markers in lymphoma.

The trial investigates treatment options for adults aged 18 to 70 with newly diagnosed higher-risk myelodysplastic syndromes HR-MDS, focusing on the feasibility of allogeneic stem cell transplantation HSCT. It compares upfront HSCT with pre-treatment using azacitidine or conventional chemotherapy based on the patients bone marrow blast counts. This phase III, open-label, randomized multicenter study aims to determine whether pre-transplant treatments affect the ability to proceed with HSCT. Participants are assigned to groups depending on their bone marrow blast levels. Those with 10% or more blasts receive either conventional chemotherapy following a 37 protocol or azacitidine given subcutaneously at 75 mgm2 daily for 7 days every 28 days for at least 4 cycles before HSCT if a suitable donor is available. Patients with less than 10% blasts may receive upfront HSCT or azacitidine prior to HSCT under similar dosing schedules. The study evaluates these different sequences of therapy to assess HSCT feasibility. During the study, participants undergo regular assessments over four years to monitor whether they proceed to HSCT. Researchers track treatment outcomes, safety, and overall feasibility by measuring the proportion of randomized patients who receive the transplantation. The trial includes follow-up for at least four years to collect data on these outcomes and ensure participant safety and treatment adherence throughout the process.

Researchers are evaluating the effect of adding gemtuzumab ozogamicin to standard chemotherapy for adults aged 18 to 60 with newly diagnosed favorable or intermediate-risk acute myeloid leukemia AML. This phase 3 study aims to reduce minimal residual disease MRD levels before transplantation and assess whether MRD-driven post-remission therapy can improve anti-leukemic outcomes. The study excludes patients with certain genetic markers or prior treatments to focus on a specific AML subgroup. Participants receive induction treatment with gemtuzumab, daunorubicin, and cytosine arabinoside, followed by consolidation therapy with adjusted doses of these drugs. After consolidation, patients undergo either autologous or allogeneic stem cell transplantation based on their MRD level. This MRD-guided approach helps tailor the intensity of post-remission therapy. Throughout the study, participants undergo MRD assessments to measure treatment activity, with the primary outcome being MRD negativity two months after starting therapy. Researchers also monitor kidney and liver function, heart health, and overall compliance with study procedures. The study involves regular clinical observations and assessments to evaluate the effectiveness of the combined treatment and its impact on MRD levels over time.

Researchers are evaluating different treatment approaches for patients with relapsed or refractory Acute Myeloid Leukemia AML. This multicenter, randomized, open-label clinical trial compares high intensity reinduction chemotherapy to low intensity therapies for patients experiencing their first or second relapse. The study addresses the need to better understand and compare these therapies as new personalized treatments emerge but have not yet been fully tested against standard chemotherapy in this setting. Participants will be randomly assigned to receive either low intensity treatments or high intensity chemotherapy. Low intensity therapies involve innovative targeted drugs alone or combined with other agents, while high intensity treatments use high doses of chemotherapy drugs, possibly combined with antibodies or targeted agents. Both treatment options will be provided according to local practices, and the study follows a pragmatic approach to reflect real-world clinical use. During the study, participants will be monitored for clinical outcomes including event-free survival over 36 months. Researchers will assess overall survival, response rates, quality of life reported by patients, and safety of the therapies. Participants health will be regularly evaluated while receiving treatment to gather data on these outcomes. The total study duration extends up to three years to capture these long-term results and better understand the benefits and risks of each therapy.

Researchers are evaluating whether letrozole is more effective than standard chemotherapy for treating patients with hormone receptor positive low-grade serous epithelial ovarian carcinoma LGSCO. This phase III, open-label, randomized trial aims to see if letrozole can extend progression-free survival compared to carboplatin and paclitaxel chemotherapy. The study also explores tumor response, quality of life, pain, overall survival, safety, and genetic markers related to the disease. Participants will be randomly assigned to one of two groups one group takes letrozole tablets daily by mouth for up to 60 months or until disease progression, while the other group receives carboplatin and paclitaxel intravenously on day 1 every 21 days for 6 to 8 cycles. The treatments are compared directly to assess their effects on cancer control and patient well-being. During the study, participants will have regular assessments including tumor response evaluations, quality of life questionnaires, pain inventory, and safety monitoring according to standard criteria. Genetic profiling and circulating tumor DNA will be analyzed to understand disease characteristics. Progression-free survival will be tracked for up to 84 months, with ongoing monitoring of overall survival and adverse events. Participants will be followed closely to observe treatment effects and side effects throughout the trial period.