Winnenden

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.

Researchers are collecting data in a registry study focused on adults with newly diagnosed or relapsed acute myeloid leukemia (AML). The study aims to gather detailed epidemiological information such as age, prognostic factors, and subgroup distributions. It also compares AML incidence and age distribution with population-based tumor registry data. Important clinical outcomes like relapse-free survival, time to relapse, cumulative incidence of relapse, and overall survival are being evaluated over a 10-year period. This study does not involve experimental treatments but instead documents current treatment strategies used in AML patients. Data collection occurs at 60 investigator sites across Germany, providing a broad overview of patient characteristics and management. There is no upper age limit, and all adult patients diagnosed according to WHO criteria, including acute promyelocytic leukemia, are eligible. Participants will be followed for up to 10 years, during which epidemiological parameters and survival outcomes will be monitored. Researchers will record relapse events, time until relapse, and survival status to understand long-term outcomes. This extensive follow-up intends to support improved knowledge about AML patient prognoses and treatment impacts over time.

Researchers are evaluating the safety and effectiveness of combining midostaurin and gemtuzumab ozogamicin (GO) with standard first-line chemotherapy in adults newly diagnosed with acute myeloid leukemia (AML). The study focuses on patients with specific genetic changes involving core-binding factor (CBF) genes or mutations in the FLT3 gene. This research addresses the challenge of relapse and resistance in AML by targeting key receptors and proteins that influence leukemia cell growth and survival. Midostaurin acts as a powerful inhibitor of these targets, and GO is an antibody-drug that kills AML cells expressing CD33, a common marker on these cancer cells. The trial includes several treatment groups combining standard chemotherapy drugs cytarabine and daunorubicin with midostaurin and GO in different ways. Midostaurin is given orally at specified doses during induction, consolidation, and maintenance phases. GO is administered intravenously during induction, either as a single dose or multiple doses depending on the group. Chemotherapy drugs are given by infusion during induction and consolidation cycles with dose adjustments based on patient response. The study explores the best tolerated dose combination and compares treatment effects in different genetic AML subgroups in separate trial parts named MODULE, MAGNOLIA, and MAGMA. Participants will undergo regular monitoring including laboratory tests, scans, and clinical assessments throughout induction, consolidation, and up to 12 maintenance cycles spanning several months. Researchers will measure the highest tolerated dose of the drug combination and track event-free survival for up to three years. Safety, treatment response, and long-term outcomes will be carefully evaluated. The study requires participants to meet specific health and laboratory criteria and includes careful follow-up to assess how well the combined treatments work and how safe they are over time.

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 conducting a prospective, multicenter, open-label randomized controlled trial to compare early catheter-directed treatment combined with conventional care versus conventional care alone in patients with high-risk pulmonary embolism. This trial focuses on patients with acute massive pulmonary embolism who have a high risk of mortality as defined by specific European Society of Cardiology (ESC) guidelines. The primary goal is to evaluate outcomes related to mortality, recurrent cardiac arrest, or persistent shock within 7 days. Participants randomized to the early catheter-interventional treatment group will undergo catheter-directed therapy within 60 minutes of randomization. This treatment may involve the use of certified devices such as aspiration thrombectomy, local fibrinolytic therapy, or ultrasound-assisted fibrinolysis, administered via transfemoral venous access. Sheaths used during the procedure are typically removed immediately after thrombectomy or 5 to 10 hours following local fibrinolysis. The comparator group will receive conventional reperfusion treatment. Preparations for fibrinolytic therapy are made in parallel to ensure timely administration if needed. During the study, participants will be closely monitored for clinical outcomes related to survival, cardiac arrest, and shock within the first week. Assessments include imaging studies such as CT angiograms and echocardiograms to confirm pulmonary embolism status and right-ventricular function. Safety and effectiveness are evaluated through this observation period. The study includes adults aged 18 years and older and excludes those with contraindications to catheter-based or fibrinolytic treatments, as well as pregnant individuals. Total study duration and follow-up details are not specified.

Researchers are evaluating whether adding elacestrant, an oral selective estrogen receptor degrader (SERD), to standard olaparib therapy improves progression-free survival in patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer who have gBRCA1/2 mutations. This phase II, multi-center, randomized, open-label study addresses the urgent need for better treatments in this patient group, who typically have low progression-free survival. Elacestrant has been approved for certain breast cancers resistant to endocrine therapy, and olaparib is an approved PARP inhibitor for gBRCA-mutated metastatic breast cancer. Participants will be randomly assigned in a 2:1 ratio to one of two treatment groups: Arm A receives 600 mg olaparib plus 400 mg elacestrant daily, while Arm B receives 600 mg olaparib daily alone. Treatment continues until disease progression, unacceptable side effects, patient withdrawal, or study completion. Blood tests are done at the start of each treatment cycle, and tumor imaging as well as quality of life assessments are conducted every three months or when progression is suspected. During the study, participants will undergo regular blood tests and imaging scans to monitor tumor status and safety. Quality of life questionnaires will also be used to assess patient well-being. Researchers will measure progression-free survival up to 48 months from randomization, defined as time until disease progression or death. The study includes ongoing safety monitoring and follow-up until the end of the study period.

Researchers are collecting data on patients diagnosed with BCR-ABL 1-negative myeloid neoplasms, a type of blood cancer classified by the WHO in 2008 and 2016. The study aims to register many patients at participating centers to better understand the disease by analyzing biological features and clinical outcomes, including quality of life. The research also focuses on identifying prognostic and predictive markers by correlating disease characteristics with patient results. Participants will be part of a registry study where samples such as bone marrow aspirates, blood, plasma, buccal swabs, and occasionally skin biopsies are collected and stored. Morphologic and genetic analyses will be performed on these samples. There is no intervention treatment; instead, the study gathers extensive clinical and biological data over time to support research. During the study, patients' clinical characteristics, quality of life, and outcome data will be assessed using specific questionnaires and defined clinical variables. Researchers will monitor treatment decisions, response to therapy, survival rates, and progression-free survival for up to 25 years. This long-term follow-up allows comprehensive tracking of the disease course and patient well-being.

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 the timing of radiotherapy for women with high-risk breast cancer who have already received neoadjuvant chemotherapy (NACT). This phase III international trial compares whether giving radiotherapy before surgery (preoperative) leads to better disease-free survival (DFS) and fewer late radiation side effects compared to the standard approach of radiotherapy after surgery (postoperative). The study aims to find the best timing for radiotherapy to prevent cancer recurrence and improve survival outcomes. Participants will receive either preoperative radiotherapy or postoperative radiotherapy after completing neoadjuvant chemotherapy and surgery. Radiotherapy may target the whole breast or chest wall and, if lymph nodes are involved, the regional lymph nodes as well. The treatment approach follows established guidelines and includes the possibility of an additional radiation boost to the tumor bed in breast-conserving therapy. During the study, participants will be monitored for disease-free survival over 6 to 10 years. Researchers will assess cancer recurrence, survival, and radiation-related late effects. Patients will undergo regular evaluations including clinical assessments and imaging as needed to follow their health status. The trial requires informed consent and includes safety monitoring throughout the long-term follow-up period.

Researchers are evaluating real-world clinical data in women with primary advanced (FIGO stage III or IV) or recurrent endometrial cancer who are receiving first-line treatment with Carboplatin, Paclitaxel, and Durvalumab (CPD). The study focuses on patients treated with CPD followed by maintenance therapy using either durvalumab alone or durvalumab combined with olaparib. This multi-center, prospective, non-interventional study aims to understand the effectiveness, safety, and patient-reported outcomes of these treatments in routine clinical practice in Germany. Participants receive first-line CPD chemotherapy after surgery and/or radiation if applicable. Following this, maintenance therapy is given with durvalumab for patients with DNA mismatch repair deficient tumors (dMMR cohort) or with durvalumab plus olaparib for those with DNA mismatch repair proficient tumors (pMMR cohort). Treatment decisions are made jointly by patients and their physicians as part of standard care, independent of the study itself. During the study, data on treatment effectiveness and safety will be collected along with patient-reported outcomes after the chemotherapy phase. Researchers will monitor real-world time to the next treatment over 12 months. Patients will complete questionnaires and their tumor mismatch repair status must be known. The study includes women aged 18 years or older and involves regular follow-ups to gather comprehensive information about the treatment effects and patient experience.