Krefeld

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC whose tumors express PD-L1 at levels of 1% or higher. This Phase III, randomized, double-blind, global study aims to compare these treatments to improve outcomes for this patient group. Participants will receive either rilvegostomig or pembrolizumab, each given intravenously on Day 1 of every 21-day cycle, combined with platinum-based doublet chemotherapy either carboplatin or cisplatin also given on Day 1 of each cycle for up to four cycles. After chemotherapy cycles, patients continue with rilvegostomig or pembrolizumab monotherapy combined with pemetrexed maintenance. The study follows patients for up to approximately six years to monitor treatment effects and safety. During the study, participants undergo assessments including imaging scans to measure tumor size, blood tests to evaluate organ function, and questionnaires about symptoms and quality of life. Researchers monitor overall survival and progression-free survival as primary outcomes, alongside other measures such as response duration and physical functioning. Safety is closely observed throughout, with study visits scheduled regularly during treatment and follow-up periods, lasting up to six years in total.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with platinum-based chemotherapy as a first treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1. This Phase III global study focuses on patients with PD-L1 tumor cell expression of 1% or higher and aims to determine which treatment provides better overall and progression-free survival. Participants will be randomly assigned to one of two study groups one group will receive rilvegostomig plus carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, while the other group will receive pembrolizumab plus the same chemotherapy options. Rilvegostomig and pembrolizumab are both given intravenously on Day 1 of each 21-day cycle, with chemotherapy given up to 4 cycles. Nab-paclitaxel may be administered on Days 1, 8, and 15 of each cycle. Treatment continues with rilvegostomig or pembrolizumab until disease progression or other criteria are met. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests to monitor organ function, and patient questionnaires about physical function and quality of life. Researchers will track overall survival, progression-free survival, response rates, and duration of response for up to approximately 6 years. Safety and immune response to rilvegostomig will also be evaluated. Participants will be closely monitored throughout the treatment and follow-up periods.

Researchers are evaluating the efficacy and safety of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced Stage III, unresectable non-small cell lung cancer NSCLC whose disease has not progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

This research aims to improve treatment and survival quality for infants, children, and young adults aged 0 to 45 years with acute lymphoblastic leukaemia ALL. It combines experiences from multiple European study groups into a master protocol that offers comprehensive risk stratification and treatment plans. The study includes randomized and interventional trials to identify therapies that may be less toxic and more effective, particularly focusing on reducing relapse and treatment-related side effects. Participants receive treatment based on a master protocol considered standard care, with additional randomized interventions testing modifications like reducing or omitting specific chemotherapy drugs such as Doxorubicin, Vincristine, and Dexamethasone. Some patients receive experimental treatments including Inotuzumab ozogamicin, Imatinib, 6-tioguanine, and Blinatumomab. Specific sub-studies also examine pharmacokinetics, neurocognitive outcomes, and cerebrospinal fluid diagnostics. The study design allows modular addition or stopping of sub-protocols and interventions. Throughout the study, participants undergo various assessments including monitoring of disease progression, side effects, and drug activity. Researchers evaluate event-free survival, disease-free survival, minimal residual disease response, and overall survival over multiple years, with follow-up periods extending up to 8 years. Participants cognitive functions and treatment toxicities are also assessed using specialized tests and questionnaires. Safety and adverse events are closely monitored to better understand treatment impacts over time.

Researchers are evaluating the effects of a 12-week moderate to high-intensity exercise program on cardiorespiratory fitness in children and adolescents who have completed acute cancer treatment. This trial focuses on pediatric patients aged 7 to 23 years and begins 6 weeks after finishing their cancer treatment. The study is a randomized controlled trial with 56 participants divided into two groups to compare exercise intervention with standard exercise recommendations. Participants in the intervention group will engage in two supervised exercise sessions each week one personal training session and one group-based session focusing on endurance, strength, mobility, and coordination. Both groups receive an initial consultation with general physical activity recommendations, a brochure, and a fitness tracker. The intervention group also receives daily activity targets adjusted biweekly. The study includes a control group receiving only exercise recommendations without supervised sessions. During the study, participants will undergo assessments at baseline, after 12 weeks of intervention, and at a 12-week follow-up to measure changes in maximal oxygen uptake VO2peak, muscle strength, mobility, balance, body composition, physical activity levels, quality of life, fatigue, cognitive function, and blood markers related to metabolic, immune, and heart health. Safety and adverse events will be monitored throughout. The total participation includes the 12-week intervention and a follow-up period extending to 24 weeks from study start.

Researchers are evaluating the safety, effectiveness, and quality of life for combining Abemaciclib with either an Aromatase Inhibitor or Fulvestrant in women with metastatic hormone receptor-positive, HER2-negative breast cancer. This Phase IV trial focuses on both pre- and postmenopausal patients receiving first-line treatment. A digital health app called CANKADO will be used to track side effects and patient-reported outcomes daily, alongside standard documentation. The study also aims to explore biomarkers to better understand treatment responses and resistance. Participants will receive either Abemaciclib combined with an Aromatase Inhibitor Anastrozole, Letrozole, or Exemestane taken orally twice daily plus daily Aromatase Inhibitor tablets every 24 hours in 28-day cycles, or Abemaciclib with Fulvestrant which is given as an injection on specific days within 28-day cycles. The two treatment groups are experimental and non-randomized, with no masking. The trial includes monitoring for side effects and quality of life throughout treatment. During the study, participants will regularly report side effects and global health status using questionnaires at multiple time points up to 24 months, including specialized breast cancer quality of life modules. Researchers will assess progression-free survival up to 48 months, as well as adverse events, hospitalizations, clinical benefit rate, overall survival, and tumor response. The use of the CANKADO app for side effect reporting is strongly recommended but not mandatory. Participants will be followed for safety and outcomes throughout the trial duration.

Researchers are investigating ribociclib combined with standard endocrine therapy for women with advanced hormone receptor-positive HR and HER2-negative breast cancer receiving first-line treatment. This phase IV, open-label study aims to understand how ribociclib works over time and identify patterns of resistance. The study also focuses on survival rates at 12 months and includes a comprehensive program to discover and validate biomarkers related to treatment outcomes. Participants will receive ribociclib once daily for 21 days followed by 7 days off, in 28-day cycles, alongside standard endocrine therapy prescribed by their doctors. The treatment follows the approved guidelines Summary of Product Characteristics for ribociclib. This trial plans to enroll 1000 female patients across 75 sites in Germany and involves extensive biomarker sampling from blood, tissue, and immune cells before, during, and after treatment or disease progression. During the study, participants will have regular assessments including survival monitoring at various time points up to 36 months, quality of life evaluations, and safety checks for treatment-related side effects. Samples for biomarker research will be collected to help understand treatment response. Follow-up includes collecting data on progression-free and overall survival, quality of life, and adverse events, with total study involvement lasting up to 36 months.

This research aims to gather detailed data and biomaterials from adults diagnosed with Acute Lymphoblastic Leukemia ALL and related diseases, including certain types of Leukemia and Non-Hodgkins Lymphoma. The registry supports ALL research and quality assurance by collecting information regardless of whether patients participate in clinical trials. The study is observational and involves adults diagnosed and treated under ALL protocols. Participants include adults aged 18 and older with ALL subtypes, other leukemias treated according to ALL protocols, and specific subtypes of Non-Hodgkins Lymphoma treated under B-ALL protocols. The study collects data prospectively on diagnosis, treatment, and outcomes, along with biomaterials related to these conditions. Participants provide information during routine clinical care and follow-up visits for up to 10 years. Data collected includes survival rates, remission status assessed by various methods including PET scans, relapse rates, quality of life questionnaires, and monitoring of toxicities and comorbidities. The study tracks overall survival and other outcomes over long-term follow-up to support research and quality assurance in adult ALL and related diseases.

This research aims to improve outcomes for infants under one year old diagnosed with acute lymphoblastic leukemia ALL or mixed phenotype acute leukemia MPAL that have a specific genetic change called KMT2A-rearrangement. The study focuses on a difficult-to-treat group of infants and evaluates a treatment protocol involving the drug blinatumomab. It is an international phase 3 treatment protocol led by the Princess Maxima Center for Pediatric Oncology. All eligible infants whose parents or guardians provide consent will receive one cycle of blinatumomab after initial induction therapy, alongside standard treatment. Medium risk infants who respond well to this first cycle might receive a second cycle of blinatumomab replacing one chemotherapy course. If the response is not sufficient, the infants will continue with the standard treatment. High risk infants may proceed to allogeneic stem cell transplantation if their minimal residual disease MRD levels are low enough after the first cycle. MRD is used to measure how well the treatment is working. Participants will be closely monitored with assessments of minimal residual disease and other health indicators up to eight years. The primary outcome measured is event-free survival over five years. Secondary outcomes include overall survival, treatment responses by risk group, relapse types, and adverse events. The study lasts until 2030, and all treatments and follow-ups are conducted under medical supervision to evaluate the effect of blinatumomab in this infant population.