Bad Liebenwerda

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.

Immune thrombocytopenia ITP is a rare blood disorder caused by an autoimmune condition that reduces platelet counts, increasing the risk of bleeding or prolonged bleeding. New treatments for ITP have emerged recently, but existing clinical studies are limited in their applicability to everyday patient care due to strict criteria. This registry aims to collect real-world clinical data and biospecimens from patients with various types of ITP to improve understanding of diagnosis, therapy, and patient outcomes in routine treatment. The registry includes patients diagnosed with primary or secondary ITP who consent to participate. Data collection occurs at defined points in the disease course either prospectively or retrospectively up to 12 months after diagnosis, provided continuous documentation is available. Biospecimens are collected and stored systematically to support research. Clinical information collected includes disease characteristics, treatment types, complications, quality of life, fatigue scores, and survival data over a follow-up period of up to 5 years. Participants provide clinical data and biosamples at enrollment, then again at 6 months and annually for up to 5 years. Assessments include platelet counts, bleeding and thromboembolic events, laboratory markers such as specific antibodies, and patient-reported outcomes like quality of life and fatigue. The study gathers epidemiological data on incidence, age, sex distribution, causes of ITP, treatment received, and remission status. The registry helps advance knowledge about ITP through long-term monitoring and standardized data collection.

Cholangiocarcinoma is a rare and aggressive bile duct tumor with poor outcomes and limited treatment options. Researchers are collecting real-world data on ivosidenib, an IDH1 inhibitor recently approved in Europe for adults with locally advanced or metastatic cholangiocarcinoma carrying an IDH1 R132 mutation who have undergone at least one prior systemic treatment. This observational study aims to evaluate ivosidenibs effectiveness, safety, and impact on quality of life in a broad patient population in Germany. Ivosidenib is given as monotherapy according to the current summary of product characteristics SmPC. The study follows patients receiving ivosidenib under routine clinical care without altering treatment decisions. It will gather data on treatment dosing, modifications, duration, and reasons for stopping treatment. Optional patient-reported outcomes PRO assessments are available for those who can participate in German. Participants are monitored during treatment and follow-up for up to 38 months from first patient in to last patient last visit. The study collects information on progression-free survival, overall survival, adverse events, quality of life related to cholangiocarcinoma, and physician treatment decisions. Data on prior therapies, concomitant medications, and subsequent cancer treatments are also recorded to assess real-world use and safety of ivosidenib.

Researchers are evaluating two treatment optionssurgery and rigid collar bracingfor unstable odontoid neck fractures in adults aged 70 years and older. These fractures are common in older adults and can affect mobility, independence, and quality of life. The study aims to determine which treatment leads to better recovery in daily living, pain, disability, and quality of life. This is a randomized controlled trial comparing surgical stabilization with conservative collar treatment for this population. Participants will be randomly assigned to either surgery involving posterior C1-C2 screw-rod fixation or conservative treatment using a rigid cervical collar for 12 weeks. Surgery typically lasts about 100 minutes with a hospital stay of approximately six days, while the collar group is monitored through patient diaries to track compliance. Those in the collar group may switch to surgery within 12 weeks if needed. Follow-up visits occur at about two weeks post-surgery, 12 weeks, and six months after treatment. During the study, participants will complete questionnaires assessing daily function, pain, and quality of life. CT scans and other medical assessments will be performed, and collar use will be recorded for those in the conservative group. Researchers will monitor treatment adherence, complications, crossover rates, and healing progress. The main outcome measured is the change in the Barthel Index for daily living activities at 12 weeks, with additional evaluations at six months. The total study duration includes follow-up visits up to six months after injury.

Researchers are observing adults with Chronic Lymphocytic Leukemia CLL who are receiving the drug venetoclax, either alone or combined with other medications such as rituximab, obinutuzumab, ibrutinib, or acalabrutinib. The study aims to understand how these treatments work in real-life settings, focusing on the effectiveness, costs related to health economics, and outcomes reported by the patients themselves. Participants receive venetoclax as prescribed by their doctors following local medical guidelines. They may receive it alone or alongside one of the other drugs mentioned. This study does not assign treatments but observes patients as they undergo therapy according to routine clinical practice across several countries. During the study, participants are monitored for their response to treatment, with the main focus on the best overall response rate within 12 months. Researchers collect data on health outcomes, costs, and patient experiences to better understand the impact of these therapies. The study spans several years, allowing long-term observation of treatment effects and outcomes.