Krefeld

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Researchers are evaluating the safety and effectiveness 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 worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

This research evaluates treatments for acute lymphoblastic leukemia (ALL) in infants, children, and young adults up to 45 years old. It combines successful approaches from multiple European study groups into a master protocol with several randomized and interventional sub-studies. The goal is to improve survival rates while reducing treatment toxicity and relapse, especially focusing on better risk stratification and targeted therapies for different patient groups, including those with genetic differences and high relapse risk. The study uses a master protocol considered as standard care, with additional randomized interventions testing if treatment can be safely reduced in some risk groups or improved with new therapies in higher risk groups. Randomizations include testing omission of drugs like Doxorubicin or Vincristine+Dexamethasone pulses, adding Inotuzumab ozogamicin or 6-tioguanine to maintenance therapy, and treating certain patients with tyrosine-kinase inhibitors or Blinatumomab. The design allows flexible addition or stopping of sub-studies, and some interventions target specific patient subgroups such as those with ABL-class fusions or Down syndrome. Participants will undergo diagnosis confirmation and follow-up at participating centers and receive assigned treatments based on risk and randomization. Researchers monitor event-free survival, disease-free survival, and minimal residual disease response up to 5 to 8 years. Additional assessments include neurocognitive testing, pharmacokinetics of drugs like Imatinib and Asparaginase, cerebrospinal fluid analysis, and quality of life evaluations. Safety and long-term outcomes are closely tracked, with at least 5 years of follow-up for most measures.

The POWER study is a randomized controlled trial designed to assess the effects of a 12-week moderate to high-intensity exercise program on cardiorespiratory fitness in children and adolescents aged 7 to 23 years who have recently completed acute cancer treatment. The study will begin 6 weeks after the end of their cancer treatment and aims to improve their maximal oxygen uptake (VO2peak) as a measure of fitness. Secondary goals include evaluating muscle strength, mobility, balance, body composition, quality of life, fatigue, cognitive function, and blood markers related to metabolism, immune function, and heart health. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive a partially supervised exercise program consisting of two weekly sessions: a group-based multi-modal exercise session and a personal training session focusing on endurance, strength, mobility, and coordination at 60-80% of maximum heart rate. Both groups will have an initial consultation with physical activity recommendations, a brochure, and a fitness tracker to monitor daily activity. The intervention group will have individualized daily activity targets adjusted every two weeks. During the study, participants will undergo a maximal incremental exercise test on a bicycle ergometer at baseline, after 12 weeks of intervention, and at 24 weeks post-inclusion to measure changes in VO2peak. Researchers will also assess additional performance markers, patient-reported outcomes, and blood markers throughout the study. Participation includes adherence tracking via fitness trackers and regular consultations to monitor progress and safety over the total study period.

Researchers are evaluating the safety, effectiveness, and quality of life for combining Abemaciclib with either an Aromatase Inhibitor or Fulvestrant in women with hormone receptor positive, HER2 negative metastatic breast cancer. This includes both premenopausal and postmenopausal patients receiving first-line treatment. The trial also explores biomarker research to understand responses and resistance to this combined endocrine therapy. Participants receive Abemaciclib 150 mg orally every 12 hours along with either an Aromatase Inhibitor (Anastrozole, Letrozole, or Exemestane) taken once daily in 28-day cycles, or Fulvestrant given by injection on days 1 and 15 of the first cycle, then on day 1 of subsequent 28-day cycles. Side effects and patient-reported outcomes are monitored using the CANKADO digital health app, allowing daily tracking alongside standard clinical documentation. During the study, patients regularly report symptoms and side effects through the app, and undergo laboratory tests, imaging, and clinical assessments to monitor disease progression and treatment safety. The main outcome measured is progression-free survival over up to 48 months. Safety and quality of life are also closely observed throughout the trial period.

Researchers are investigating the use of ribociclib combined with standard endocrine therapy as a first-line treatment for women with advanced hormone receptor positive (HR+) and human epidermal growth factor receptor negative (HER2-) breast cancer. This phase IV, open-label, single-arm study aims to evaluate the progression-free survival (PFS) and overall survival (OS) rates at 12 months, along with quality of life, treatment toxicity, and comprehensive biomarker analysis to understand patterns of treatment efficacy and resistance. Participants will receive ribociclib orally at a dose of 600 mg daily for 21 consecutive days followed by 7 days off, in 28-day cycles, combined with standard endocrine therapy according to current guidelines and local practice. The study includes extensive biomarker sampling before, during, and after treatment or at disease progression, including blood, tissue, and immune cell analyses to support translational research. During the trial, patients will attend scheduled visits for monitoring and assessments including survival status, safety evaluations, and quality of life questionnaires. Biomarker samples such as circulating tumor DNA and RNA, serum, plasma, and tumor tissue will be collected to evaluate biological changes. The trial plans to enroll 1000 female patients across 75 sites in Germany, with comprehensive follow-up to track treatment outcomes and long-term safety.

Researchers are collecting detailed information on adults diagnosed with Acute Lymphoblastic Leukemia (ALL) and related blood cancers such as other leukemias and certain types of Non-Hodgkin's Lymphoma. The purpose is to gather real-world data on diagnosis, treatments, and outcomes to support ALL research and improve quality of care. This registry includes patients whether or not they are part of other clinical trials. Participants included in this registry are adults aged 18 and older diagnosed with ALL or similar leukemias who are treated according to established ALL treatment protocols. It also includes patients with specific subtypes of Non-Hodgkin's Lymphoma treated according to B-ALL protocols. The study involves collecting clinical data and biological samples over time to understand treatment responses and disease progression. Throughout the study, researchers will monitor participants' health outcomes, including overall survival for up to 10 years. Data collected will cover diagnostics, treatments received, and patient outcomes in routine clinical care. This long-term follow-up aims to provide valuable insights into the effectiveness of current therapies and patient experiences with these blood cancers.

Researchers are evaluating a treatment protocol using blinatumomab for infants under 1 year old diagnosed with acute lymphoblastic leukemia (ALL) or mixed phenotype acute leukemia who have a specific genetic change called KMT2A-rearrangement. This study aims to improve outcomes for these very young patients with this challenging disease. The trial is a Phase 3 international collaboration focusing on this rare population. All enrolled infants will receive one cycle of blinatumomab after their initial induction therapy, alongside standard treatment. Medium risk patients who respond well to the first cycle may receive a second cycle replacing one chemotherapy course after consolidation therapy. Those who do not respond well will follow the current standard treatment. High risk patients who become minimal residual disease (MRD) negative after the first blinatumomab cycle may be eligible for allogeneic stem cell transplantation. MRD levels guide treatment decisions throughout the protocol. Participants will be closely monitored with assessments including MRD testing to measure response to treatment. The main outcome measured is event-free survival over 5 years. Parents or legal guardians will provide informed consent prior to enrollment. The study involves continuous intravenous infusion of blinatumomab over four weeks per cycle and follows infants through treatment and follow-up to evaluate long-term outcomes and safety.