Winnenden

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.

Researchers are evaluating the real-world effectiveness of asciminib in adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase Ph CML-CP. This observational study compares patients who are newly diagnosed or previously treated with one ATP-competitive tyrosine kinase inhibitor TKI to those treated with other TKIs. The study aims to assess tolerability, safety, and molecular response outcomes in routine clinical care. Participants are grouped into cohorts based on their treatment those receiving asciminib, those newly diagnosed treated with imatinib, and those newly diagnosed treated with second-generation TKIs such as dasatinib, bosutinib, or nilotinib. Treatment decisions are made by physicians prior to enrollment, and treatment must not have started more than 14 days before joining the study. The study follows patients over time to document treatment patterns, dose changes, interruptions, and discontinuations. Participants will attend routine follow-up visits and complete patient-reported outcome questionnaires assessing medication adherence, quality of life, and work productivity at multiple time points up to 24 months. Researchers will measure major molecular response at 12 months as the primary outcome and evaluate various secondary molecular responses, reasons for treatment changes, and quality of life scores. The study duration extends through September 2030, allowing long-term observation of treatment effectiveness and safety.

Researchers are collecting data in a registry study for adults diagnosed with acute myeloid leukemia AML, including newly diagnosed and relapsed cases. The study aims to gather important information about the diseases epidemiology, such as patient age and prognostic factors, and to compare incidence and age distribution with population tumor registry data. It also evaluates key clinical outcomes like relapse-free survival, time to relapse, cumulative incidence of relapse, and overall survival. This observational study does not involve treatment assignment but documents treatment strategies used by patients. Data is gathered over a 10-year period to thoroughly monitor outcomes and disease patterns. The registry also collects information on complete remission rates, treatment-related mortality, therapy-associated morbidity, and quality of therapy and diagnosis. Additionally, the study seeks to validate known prognostic factors and explore new ones while describing new therapies and supportive care measures. Participants are adults aged 18 years and older diagnosed with AML according to WHO criteria, including acute promyelocytic leukemia. The study involves long-term follow-up with yearly assessments over 10 years. Researchers will evaluate epidemiological parameters and important survival outcomes. Since this is an observational registry, participants continue with their usual care while data is collected. The study is sponsored by Technische Universitt Dresden and involves multiple sites in Germany.

Researchers are evaluating the safety and effectiveness of combining midostaurin and gemtuzumab ozogamicin with standard chemotherapy as a first treatment for patients newly diagnosed with acute myeloid leukemia AML who have specific genetic changes in core-binding factor CBF genes or mutations in the FLT3 gene. This phase III clinical trial aims to improve outcomes in these groups where relapse and resistance to treatment remain challenges. Midostaurin and gemtuzumab ozogamicin target key molecules involved in leukemia cell growth and survival, potentially enhancing treatment effects. The trial includes several parts Phase I MODULE tests increasing doses of midostaurin and gemtuzumab ozogamicin combined with standard chemotherapy drugs cytarabine and daunorubicin. Phase II includes two studies MAGNOLIA compares midostaurin plus chemotherapy and gemtuzumab ozogamicin versus chemotherapy and gemtuzumab ozogamicin alone for CBF AML patients MAGMA compares chemotherapy plus midostaurin and gemtuzumab ozogamicin versus chemotherapy plus midostaurin alone for patients with FLT3 mutations. Doses and schedules vary by study part, with midostaurin taken orally and gemtuzumab ozogamicin given intravenously during induction cycles. Participants will undergo treatment cycles including induction, consolidation, and maintenance phases, with regular monitoring for safety and response. Researchers will assess outcomes such as the highest tolerated dose of the drug combination, event-free survival up to three years, remission rates, relapse rates, overall survival, and early mortality. The study involves frequent clinical visits, laboratory tests, and imaging to track disease status and side effects throughout the treatment and follow-up periods.

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.

Researchers are evaluating treatments for patients with high-risk pulmonary embolism, a serious condition where blood clots block blood flow in the lungs. The trial compares early catheter-directed treatment plus conventional care against conventional care alone. This open-label, multicenter, randomized controlled trial aims to assess which approach better reduces mortality and severe complications within seven days. Participants are randomly assigned to one of two groups. One group receives conventional care following guidelines, including reperfusion treatments, with catheter-based intervention only if no improvement occurs. The other group undergoes catheter-interventional treatment within 60 minutes of randomization, using certified devices such as aspiration thrombectomy and local fibrinolytic therapy, possibly combined with ultrasound assistance. Sheaths used during the catheter procedures are removed shortly after treatment, and fibrinolytic drugs are prepared concurrently to avoid delays if needed. Throughout the study, researchers monitor participants closely, measuring outcomes like death from any cause, recurrent cardiac arrest, and shock within seven days. Secondary outcomes include mortality at 30 days, bleeding events, use of life support devices, heart function changes via echocardiography, ICU stay length, and time to stabilize blood flow. The trial is led by Leipzig Heart Science gGmbH and participants are followed up to assess these key health indicators.

Researchers are evaluating elacestrant compared to standard endocrine therapy in patients with estrogen receptor-positive ER and human epidermal growth factor receptor 2-negative HER2- breast cancer who have a relapse detected by circulating tumor DNA ctDNA. This international, multi-center, randomized, open-label phase III trial focuses on patients without distant metastasis who show ctDNA positivity during screening. The study aims to assess whether elacestrant can improve outcomes over the current standard endocrine treatments. The study consists of two phases. First, during the ctDNA screening phase, patients on standard adjuvant endocrine therapy will have plasma samples collected every six months for about 5.7 years to detect ctDNA. Patients who test positive will undergo imaging to confirm no distant metastasis and then be randomized 11 to either continue their current endocrine therapy or receive elacestrant 400 mg orally once daily. Treatment duration depends on prior endocrine therapy length, lasting between 2 to 6 years. Intensive follow-up with ctDNA testing and imaging occurs for up to 3 years after randomization. Participants will be monitored closely with blood tests for ctDNA at weeks 4, 16, and every 16 weeks thereafter, along with yearly mammograms, bone scans, and CT scans every 16 weeks to detect metastases or recurrences. Safety, quality of life, and overall survival are assessed throughout, with follow-up continuing until three years after the last patient enrolls. The primary outcome measured is distant metastasis-free survival at 6.25 years after the first randomization.

Researchers are studying patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer who have gBRCA12 mutations. This study aims to evaluate whether adding elacestrant, a new oral estrogen receptor blocker, to the standard olaparib treatment can improve progression-free survival compared to olaparib alone. This is a phase II, multi-center, randomized, open-label study with patients assigned in a 21 ratio to two different treatment groups. Participants randomized to Arm A will receive 600 mg of olaparib daily plus 400 mg of elacestrant daily, while those in Arm B will receive 600 mg of olaparib daily alone. Treatment will continue until disease progression, unacceptable side effects, patient withdrawal, or the study ends. Pre- and perimenopausal women, as well as men, will also receive a GnRH analogue at least two weeks before treatment starts. Dose modifications are provided for managing specific side effects. During the study, blood tests will be done at the start of each treatment cycle, and imaging scans along with quality of life assessments will be performed every three months or if disease progression is suspected. Researchers will measure progression-free survival, overall survival, treatment failure times, response rates, clinical benefit, adverse events, and treatment compliance. Participants may remain in the study for up to 48 months, with an average treatment duration of about 12 months per patient.

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.

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.