Schwabisch Hall

Researchers are evaluating various approved injectable and oral disease-modifying treatments (DMTs) in patients with relapsing multiple sclerosis (RMS) in Germany. This observational, non-interventional, multicenter, open-label study collects primary data prospectively over up to four years, alongside retrospective data. The study captures medical history, disease duration, laboratory values, disability scores (EDSS), MRI results, and relapse information to provide real-world insights into treatment use and outcomes. Patients receiving routine medical treatment with any approved injectable or selected oral DMTs—including ofatumumab, glatiramer acetate, interferon 21, teriflunomide, dimethyl fumarate, and diroximel fumarate—are enrolled without treatment allocation by the study. Two cohorts are observed: one treated primarily with injectable DMTs and another with injectable or oral DMTs. The core study period lasts about two years, with an optional extension providing an additional two years of observation, totaling up to four years. Follow-up visits and monitoring happen at the investigator's discretion and may include telemedicine. During the study, participants provide data through questionnaires and electronic case report forms. Routine clinical care procedures, such as diagnostic tests and monitoring, continue as usual. Researchers measure the proportion of patients continuing their baseline treatment at 24 months and collect ongoing clinical and imaging data. The study emphasizes real-world treatment patterns, safety, and disease activity over the extended follow-up period.

Researchers are evaluating the clinical utility of serum neurofilament light (sNfL) as a prognostic marker for disease activity in patients with relapsing multiple sclerosis (MS). This prospective, multicenter, observational, non-interventional study in Germany aims to understand how sNfL values can influence patient management and treatment decisions. The study focuses on patients treated with category 1 disease-modifying therapies (DMTs) who have incorporated sNfL testing into their care. Participants will either continue their current category 1 DMT, which includes therapies such as dimethylfumarate, glatiramer acetate, interferon beta, and teriflunomide, or switch to ofatumumab based on their physician’s clinical judgment. There is no treatment allocation by the study itself. Data collection will cover up to 24 months, and the frequency of visits and assessments will follow routine clinical practice without a fixed protocol. During the study, baseline and follow-up data will be gathered according to standard care recommendations, including clinical evaluations and sNfL measurements. Researchers will monitor the proportion of patients with high sNfL levels over time to assess disease activity. The observational period is flexible and guided by the treating physician, with no additional diagnostic or monitoring procedures beyond standard care. Participants will be followed for up to two years to better understand how sNfL influences treatment management in relapsing MS.

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 evaluating the recurrence-free survival of women with advanced HRD-positive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and clear cell carcinoma of the ovary after complete tumor removal. This phase II, randomized, open-label study compares two treatment strategies involving chemotherapy and maintenance therapy with niraparib. The study focuses on patients with no residual tumor mass following primary tumor debulking and aims to determine if fewer cycles of chemotherapy followed by niraparib maintenance are as effective as the standard number of chemotherapy cycles plus niraparib. Participants are randomly assigned to one of two groups: one receiving 3 cycles of carboplatin plus paclitaxel chemotherapy followed by niraparib maintenance, and the other receiving 6 cycles of carboplatin plus paclitaxel followed by niraparib maintenance. Randomization is based on genetic analysis and disease stage. Tumor assessments using CT or MRI scans will be done at defined intervals after treatment starts and during maintenance. Blood markers and safety monitoring will be conducted regularly throughout the treatment period. During the study, patients will have clinical visits every 3 weeks during chemotherapy and monthly during the first 11 months of maintenance, then quarterly thereafter. Safety is monitored continuously through adverse event reporting. The study plans to enroll 640 patients across about 60 sites in six European countries over 36 months. The primary outcome measured is recurrence-free survival over 8 years.

Researchers are evaluating sacituzumab tirumotecan as a second-line treatment for female participants with recurrent or metastatic cervical cancer who have previously received platinum chemotherapy and anti-PD-1/PD-L1 therapy. This study has two phases: a safety run-in to assess the safety and efficacy of sacituzumab tirumotecan, followed by a Phase 3 portion comparing sacituzumab tirumotecan to treatment chosen by physicians. The study aims to determine if sacituzumab tirumotecan improves overall survival, especially in participants with high TROP2 expression. Participants will receive intravenous infusions of sacituzumab tirumotecan during the safety run-in phase. In the Phase 3 portion, participants are randomized to receive either sacituzumab tirumotecan or one of several physician-chosen treatments including pemetrexed, tisotumab vedotin, topotecan, vinorelbine, gemcitabine, or irinotecan, all given by IV infusion. This setup allows comparison of sacituzumab tirumotecan monotherapy against standard second-line therapies. Throughout the study, participants will undergo evaluations for tumor response, adverse events, and overall survival, with monitoring lasting up to approximately 51 months for the safety run-in and about 43 months for the Phase 3 portion. Researchers will use imaging and tumor tissue analysis to assess measurable disease and TROP2 expression. Safety and treatment tolerability will be closely observed, including tracking discontinuations due to adverse events.

Approximately 1100 adult participants will be enrolled after central FRα testing into two independent cohorts (about 550 FRα-high and 550 FRα-low) and randomized 1:1 within each cohort to receive AZD5335 or the relevant standard of care (mirvetuximab soravtansine in FRα-high; investigator's choice single-agent chemotherapy in FRα-low). Participants will remain on assigned treatment and undergo regular tumor evaluations per RECIST v1.1 until disease progression or another reason for treatment discontinuation. All participants will be followed for overall survival. An independent data monitoring committee (IDMC) of external experts will periodically review unblinded safety and interim efficacy to confirm participant safety and study integrity.

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, 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 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 collecting long-term follow-up data on patients with multiple myeloma who took part in therapy studies conducted by the German-Speaking Myeloma Multicenter Group (GMMG). This observational registry study aims to track important outcomes such as overall survival, progression-free survival, and follow-up duration to support scientific research. The registry combines data from previous trials with ongoing patient information for comprehensive analysis. The GMMG Myeloma Registry is a national, observational, and non-interventional study that includes both past and ongoing patient data. It incorporates study databases from various GMMG trials, including the phase 3 GMMG-HD6 trial, which evaluated adding the monoclonal antibody elotuzumab to standard therapy for newly diagnosed multiple myeloma patients eligible for transplant. Data is collected from 35 centers across Germany, with no limit on sample size. Participants will be followed during their standard care treatment until death, loss to follow-up, or withdrawal of consent. Follow-up visits occur every six months until the first disease progression and then yearly afterward. Clinical data is securely stored and regularly monitored with automated checks to ensure accuracy. The main outcome tracked is progression-free survival after five years and through the study's completion, averaging one additional year of observation.