Castelfranco Veneto

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 the safety and effectiveness of bomedemstat (MK-3543) compared with the best available therapy (BAT) in adults with essential thrombocythemia (ET) who have not responded well to or cannot tolerate hydroxyurea. This phase 3 clinical trial aims to determine if bomedemstat provides a better durable clinicohematologic response in these participants. Participants will receive either bomedemstat as an oral capsule or one of the best available therapies, including anagrelide (oral capsule), busulfan (oral tablet), interferon alfa or its pegylated forms (subcutaneous solution), or ruxolitinib (oral tablet). The study involves a randomized, open-label design where treatments are compared directly. Throughout the study, participants will be monitored for their hematologic response up to about 52 weeks. Assessments include platelet and neutrophil counts before starting treatment to ensure eligibility. Safety and efficacy are tracked to evaluate the long-term impact of the treatments on ET.

Researchers are evaluating the safety and effectiveness of new treatment combinations for participants with metastatic colorectal cancer (mCRC). This Phase II global study uses a master protocol with substudies focused on participants who have mismatch-repair-proficient (pMMR) or microsatellite stable (MSS) mCRC without liver metastases and who have not previously received systemic treatment for advanced disease. Participants will be randomly assigned to one of two treatment groups: one receiving Volrustomig combined with FOLFIRI (a regimen of irinotecan, fluorouracil, and leucovorin) plus bevacizumab, and the other receiving FOLFIRI plus bevacizumab only. All medications will be given as intravenous infusions. This modular study takes place across multiple centers worldwide. During the approximately three-year participation, researchers will measure progression-free survival and monitor adverse events. Participants will undergo regular evaluations including tumor assessments by RECIST 1.1 criteria and organ function tests. Safety and treatment effects will be closely observed throughout the study period to understand the impact of these new treatment combinations.

The trial investigates early stage Follicular Lymphoma (grades I-IIIA) in patients who have not received prior treatment. It is a prospective, multicenter, open-label, phase III randomized clinical trial comparing two treatment approaches. The study aims to evaluate the progression-free survival over up to 33 months, including a 9-month treatment period followed by 24 months of follow-up. Participants will be randomly assigned to one of two groups. The first group will receive standard involved-site radiation therapy at a dose of 24 Gy. The second group will receive the same radiation therapy followed by obinutuzumab infusions: 4 weekly doses and then 4 additional doses every 3 weeks, totaling 8 doses. This design allows comparison of radiation alone versus radiation combined with obinutuzumab. During the study, participants will have assessments including PET/CT scans for staging, bone marrow biopsies, and blood tests for specific lymphoma markers. Performance status will be monitored, and liver and kidney function will be evaluated. Safety and effectiveness will be tracked throughout treatment and for two years afterward. The main outcome measured is progression-free survival from treatment start through the follow-up period.

Researchers are evaluating the real-life effectiveness, safety, and usage patterns of Octapharma's factor VIII (FVIII) concentrates Nuwiq, Octanate, and Wilate in patients with severe haemophilia A who have either never been treated or have had minimal previous treatment. This study focuses on previously untreated patients (PUPs), often young children, and minimally treated patients (MTPs), to better understand treatment outcomes and inhibitor development in routine clinical practice. Because haemophilia A is rare and treatment practices vary, especially for PUPs, collecting real-world data is important to improve treatment guidelines and benefit-risk assessments. The study observes patients prescribed Octapharma's FVIII concentrates without changing their treatment, capturing how these products are used in everyday healthcare settings. There are no experimental interventions as this is a non-interventional study. The study includes patients starting or continuing treatment with these FVIII concentrates, monitoring their usage, dosing, and frequency as determined by their healthcare providers. Participants are monitored for effectiveness by tracking the annual rate of breakthrough bleeding episodes and safety by recording adverse drug reactions over 100 exposure days. Data on inhibitor development is also collected. Patients of all ages and genders with severe haemophilia A are eligible if they meet treatment history criteria. Informed consent is obtained before data collection. The study gathers information from routine clinical visits and treatment records without additional procedures or interventions.

This research investigates Diffuse Large B-cell Lymphoma (DLBCL) and High-Grade B-cell Lymphoma (HGBCL), which are diverse types of lymphomas affecting adults. The study aims to understand how genetic changes in the MYC gene relate to the lymphoma's genetic makeup and immune environment, and how these factors might influence patient outcomes. It focuses especially on MYC rearrangements and gain of copy number (GCN), which may affect prognosis and response to treatment. Participants in this observational study include patients diagnosed with nodal or extranodal DLBCL or HGBCL, including certain subtypes like double and triple hit lymphomas. The research examines patients who have received curative first-line treatments such as R-CHOP or intensified chemotherapy regimens. The study involves reviewing histological samples, including immunohistochemistry and genetic analyses, to explore the relationship between MYC alterations and lymphoma characteristics. During the study, researchers evaluate clinical, genetic, and histopathological features from diagnosis through up to 36 months of follow-up. Detailed tissue analysis and genetic testing are performed to assess MYC rearrangements or GCN. The study also looks at the lymphoma's immune environment and tracks patient outcomes to identify correlations that could improve prognostic markers and treatment strategies.

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 treatments for adults with relapsed or refractory Acute Myeloid Leukemia (AML) in this randomized, open-label clinical trial. The study compares the effects of low-intensity therapies versus high-intensity reinduction chemotherapy in patients experiencing their first or second relapse. Funded by the European Commission, the trial aims to determine whether low-intensity treatments provide similar clinical benefits as high-intensity chemotherapy over a 36-month period. Participants will receive either high-intensity chemotherapy regimens, such as combinations including Cytarabine, Mitoxantrone, or Fludarabine, or low-intensity therapies like Venetoclax with hypomethylating agents, Gilteritinib, or other targeted drug combinations. Both treatment options will be selected based on local availability and clinical suitability. The study follows a pragmatic approach, focusing on real-world treatment settings and personalized options for each patient. Throughout the trial, researchers will monitor patient outcomes, including event-free survival over three years. Assessments will include clinical evaluations, treatment adherence, and safety monitoring. Patients must be able to provide informed consent and will be followed closely to compare the effectiveness and tolerability of the different therapy intensities in managing relapsed or refractory AML.

Researchers are evaluating whether letrozole, a hormonal therapy, is more effective than standard chemotherapy in treating women with hormone receptor positive low-grade serous epithelial ovarian carcinoma. This phase III, randomized, open-label trial conducted in Italy aims to see if letrozole can extend the time patients live without their cancer worsening compared to the usual chemotherapy treatment of carboplatin and paclitaxel. The study also investigates effects on tumor response, quality of life, pain, safety, and overall survival, along with genetic profiling and disease monitoring through blood tests. Participants will receive either letrozole tablets or the standard chemotherapy regimen of carboplatin AUC 5 and paclitaxel 175 mg/m2. Treatments are given as first-line therapy after surgery. The study includes detailed assessments of estrogen and progesterone receptor status and requires patients to have had surgery with residual disease status assessed. The trial also includes translational research components analyzing gene mutations and circulating tumor DNA to understand treatment response. During the study, women will be monitored for progression-free survival over a period of 54 to 84 months. Researchers will evaluate tumor response, health-related quality of life using specific questionnaires, pain levels, and safety according to established criteria. Imaging scans, blood tests, and physical exams will be regularly conducted to track disease status. Participants must provide informed consent and will be followed closely to assess long-term outcomes and side effects throughout the trial period.