Mutlangen

Researchers are studying the real-world effectiveness, safety, and patient experience 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 patient compliance and quality of life among those treated with ribociclib, abemaciclib with endocrine therapy, or endocrine therapy alone. The goal is to understand treatment decisions and how these therapies perform in routine care settings. Participants receive treatment as prescribed by their doctors based on local guidelines and product information for ribociclib plus aromatase inhibitor with or without LHRH, abemaciclib with endocrine therapy plus or minus LHRH, or endocrine therapy alone plus or minus LHRH. There is no random treatment assignment since this is an observational study. Baseline data are collected shortly before or after treatment initiation depending on the cohort. During the study, patients will be followed for up to 36 months to monitor invasive disease-free survival and other health outcomes. Researchers will collect information on adverse events, treatment modifications, adherence measures, quality of life questionnaires, and socio-economic factors at various timepoints. This will provide insights into treatment tolerability, patient compliance, and overall impact on quality of life in a real-world setting.

Researchers are evaluating treatments for patients with high-risk chronic lymphocytic leukemia CLL, a type of blood cancer that is aggressive and currently incurable. This phase 3, open-label, multicenter, randomized study aims to compare the effectiveness of a triple drug combination acalabrutinib, obinutuzumab, and venetoclax against a double combination obinutuzumab and venetoclax in prolonging progression-free survival PFS for patients with specific high-risk genetic features such as 17p-deletion, TP53 mutation, complex karyotype, or unmutated IGHV gene status. The study addresses a crucial medical need for better treatments in this difficult-to-treat group. Participants will be randomly assigned to one of two treatment groups. One group receives the triple combination of acalabrutinib, obinutuzumab, and venetoclax, while the other group receives obinutuzumab plus venetoclax. Obinutuzumab is given as intravenous infusions on specific days across six cycles. Venetoclax is taken orally with a carefully planned dose escalation and maintenance over 12 cycles. Acalabrutinib is administered orally twice daily during cycles 15 to 24. The study explores whether adding acalabrutinib improves outcomes by using these fixed-duration, chemotherapy-free regimens. Throughout the study, participants will undergo regular assessments to monitor response and safety, including checks for minimal residual disease MRD and overall survival. These evaluations occur up to 50 months after the first patient is enrolled. Researchers will also track progression-free survival, complete and overall response rates, event-free survival, duration of response, and time to next treatment. Safety monitoring and laboratory tests will be performed as part of study visits. The total study participation is expected to last several years to capture long-term outcomes for this high-risk patient population.

Researchers are studying an experimental drug called odronextamab, combined with chemotherapy, in adults with Diffuse Large B-cell Lymphoma DLBCL. The study includes patients who have not been treated before, as well as those whose lymphoma has returned or not responded to prior treatment. The goal is to evaluate the safety, dosing, and effectiveness of odronextamab combined with chemotherapy compared to the current standard treatment of rituximab plus chemotherapy. The study consists of three parts Part 1A involves dose escalation to find safe levels of odronextamab Part 1B explores two dosing schedules of odronextamab with chemotherapy and Part 2 compares the combination of odronextamab with chemotherapy against rituximab with chemotherapy. Odronextamab and rituximab are given by intravenous infusion, while chemotherapy drugs cyclophosphamide, doxorubicin, and vincristine are given intravenously and prednisone or prednisolone is taken orally. Participants will have regular evaluations including safety monitoring, blood tests to measure drug levels and antibodies, and assessments of quality of life and physical functioning. The study will track side effects, response to treatment, survival, and disease progression over several years. The total study duration can be up to five years, with ongoing assessments to understand the long-term impact of the treatments.

Researchers are evaluating different treatment combinations for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma CLLSLL. This phase 3 study compares how well sonrotoclax combined with either obinutuzumab or rituximab works against venetoclax plus rituximab. The study also monitors the safety of these treatments as part of the comparison. Participants will receive one of four treatment combinations sonrotoclax with obinutuzumab, sonrotoclax with rituximab, sonrotoclax with obinutuzumab guided by minimal residual disease evaluation, or venetoclax with rituximab. Sonrotoclax and venetoclax are given orally, while obinutuzumab and rituximab are given intravenously. Treatment continues with evaluations based on disease response and minimal residual disease status. During the study, participants will have regular assessments including disease progression, response rates, overall survival, quality of life, and safety monitoring. These assessments include clinical evaluations, laboratory tests, and quality of life questionnaires. The primary outcome is progression-free survival up to about 51 months, with other outcomes assessed up to 84 months. Participants are monitored from study start through treatment and follow-up periods, which may last several years.

Researchers are evaluating the effectiveness and safety of combining sonrotoclax with zanubrutinib compared to zanubrutinib with placebo in adults who have relapsed or refractory mantle cell lymphoma MCL. This phase 3 randomized, double-blind study aims to determine if sonrotoclax plus zanubrutinib can improve outcomes for patients who have received prior treatments including anti-CD20 monoclonal antibodies or chemoimmunotherapy. The trial is sponsored by BeOne Medicines and includes patients with measurable disease and adequate organ function. Participants are randomly assigned to one of two groups one receives sonrotoclax plus zanubrutinib taken orally, and the other receives a placebo plus zanubrutinib, also taken orally. Treatment continues under blinded conditions to compare the effects of the study drug combination versus placebo. The study includes multiple outcome measures such as progression-free survival, overall survival, response rates, and quality of life assessments over periods ranging from about 41 to 92 months. During the trial, participants will undergo regular assessments including tumor evaluations, laboratory tests, and quality of life questionnaires using specific tools like the EORTC-QLQ-NHL-HG29 and EORTC-QLQ-C30. Safety is closely monitored from the first dose until 30 days after the last dose. The study spans several years, allowing researchers to track long-term outcomes and treatment-emergent side effects while participants continue follow-up visits according to the study schedule.

Researchers are evaluating an experimental drug called odronextamab combined with lenalidomide in adults who have relapsed or refractory follicular lymphoma FL or marginal zone lymphoma MZL, which are subtypes of Non-Hodgkins lymphoma. The study aims to assess the safety, tolerability, and proper dosing of this new combination and compare its effectiveness to the current standard treatment of rituximab combined with lenalidomide. The research also explores side effects, drug levels in the blood, immune responses to the drug, and impacts on quality of life and daily functioning. The study has two parts Part 1 is a safety phase where all participants receive odronextamab plus lenalidomide to determine the appropriate dose. Part 2 is randomized and compares two groupsone receiving odronextamab with lenalidomide, and the other receiving rituximab with lenalidomide followed by lenalidomide alone. Participants receive these treatments according to the study protocol during these phases. Throughout the study, participants will undergo various assessments including safety monitoring for side effects, measurement of drug concentrations and immune responses, imaging scans to evaluate disease status, and quality-of-life questionnaires. The primary outcomes include tracking dose-limiting toxicities up to 35 days and treatment-emergent adverse events up to 2 years. Longer-term outcomes such as progression-free survival and overall survival will be followed for up to 5 years, with ongoing evaluations to understand the treatments impact over time.

Researchers are evaluating an experimental drug called odronextamab for adults with previously untreated follicular lymphoma, a type of non-Hodgkin lymphoma. The study aims to assess the safety, tolerability, and effectiveness of odronextamab compared to rituximab combined with chemotherapy, which is the current standard treatment. Additional questions include the study drugs side effects, blood levels, antibody responses, and impact on quality of life and daily activities. The study has two parts Part 1 is a non-randomized safety phase where all participants receive odronextamab alone. Part 2 is randomized and compares two groups one receiving odronextamab followed by maintenance treatment, and the other receiving rituximab with chemotherapy followed by rituximab maintenance. Chemotherapy types include CHOP, CVP, or bendamustine regimens, all given according to protocol. Participants will undergo regular assessments including imaging scans like CT or MRI to measure disease, blood tests to monitor drug levels and antibodies, and questionnaires to evaluate quality of life. Researchers will track safety through dose-limiting toxicities and treatment-emergent adverse events for up to two years, and measure treatment response and survival outcomes for up to five years. Overall participation may last several years to monitor long-term effects and disease progression.

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 treatment options for Waldenstrf6ms macroglobulinemia WM, a condition where chemotherapy often results in low complete or very good partial response rates and limited duration of response. WM patients tend to be older and may not tolerate chemotherapy side effects well, so treatments without chemotherapy are especially appealing. Venetoclax, a drug approved for related blood cancers, has shown promising activity and low toxicity in WM patients, including those previously treated with Ibrutinib or with certain genetic mutations. Ibrutinib, while effective, requires continuous use and its success varies with genetic factors, limiting its adoption as a standard treatment. Fixed-duration treatment combining Venetoclax and Rituximab has shown deep responses in related diseases, suggesting it might improve outcomes for newly diagnosed WM patients. The study is an international, phase II, open-label, randomized trial comparing two treatment approaches for newly diagnosed WM patients needing therapy. One group receives a combination of Venetoclax and Rituximab, with Venetoclax dose gradually increased during the first 28-day cycle and continued for 12 cycles alongside Rituximab given intravenously monthly. The other group receives a combination of Dexamethasone, Rituximab, and Cyclophosphamide for six 28-day cycles. The study uses genetic markers MYD88 and CXCR4 to stratify patients before randomization. About 80 patients will participate across multiple sites. Participants will be monitored for treatment response and safety during and after therapy, with assessments including response rates at 12 and 24 months, progression-free survival over six years, and quality of life measured by questionnaires. Safety evaluations involve tracking adverse events, laboratory tests, heart monitoring, and vital signs over 12 months. The main goal is to see if Venetoclax plus Rituximab leads to better deep response rates compared to the standard chemotherapy combination. This trial aims to provide data supporting new treatment standards for WM.

This research aims to gather a large group of patients diagnosed with BCR-ABL 1-negative myeloid neoplasms, classified according to WHO 20082016 standards. The study focuses on collecting detailed clinical, biological, and quality-of-life data to better understand disease characteristics, outcomes, and potential prognostic markers. It is an observational registry conducted by the University of Ulm to improve knowledge about this condition over time. Participants in this registry will provide various biological samples, such as bone marrow aspirate, peripheral blood, plasma, buccal swabs, and occasionally skin biopsies. These samples will be used for morphological and genetic analysis. The study does not involve any experimental treatments but collects comprehensive data and samples to assess disease features and clinical outcomes. Throughout the study, researchers will collect clinical information using a defined catalog of relevant variables and assess quality of life with specific symptom assessment forms. They will track outcomes including treatment decisions, responses, overall survival, progression-free survival, and duration of response for up to 25 years. This long-term follow-up allows detailed monitoring of patient health and disease progression.