Ludenscheid

Researchers are evaluating bronchoscopic lung volume reduction using thermoablation as a treatment for patients with severe emphysema. This prospective, randomized, open-label clinical trial compares this interventional procedure to the usual conservative standard therapy guided by GOLD guidelines. The study aims to provide evidence supporting this procedure as an effective and safe treatment option to improve care for emphysema patients based on current medical knowledge. The treatment involves using the InterVapor® System, which applies heated water vapor to ablate targeted lung regions. This process triggers lung remodeling through inflammation and healing, reducing tissue and air volume in diseased lung areas. The resulting lung volume reduction is expected to improve lung function, exercise capacity, and quality of life by decompressing healthier lung segments and enhancing respiratory muscle efficiency. Participants will be monitored for changes in patient-reported disease-specific quality of life over 9 months. The study includes assessments such as pulmonary function tests, high-resolution CT scans, blood gas measurements, dyspnea scoring, and a 6-minute walk test. Researchers will also evaluate safety and treatment effects through follow-up visits, with total participation lasting at least 9 months to track outcomes and any adverse events.

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 studying adult patients with newly diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) to evaluate different treatment approaches involving tyrosine kinase inhibitors (TKIs) combined with low-dose chemotherapy. The trial aims to compare Ponatinib versus Imatinib, both combined with chemotherapy, and to assess different strategies based on patients' molecular response to therapy. The study challenges the current standard of care by examining alternative treatments for patients who respond well or poorly to initial therapy. Participants receive either Imatinib at 600 mg once daily with chemotherapy or Ponatinib at 45 mg once daily with chemotherapy. Patients with molecular failure or intermediate response receive one cycle of Blinatumomab before stem cell transplantation (SCT). Those who achieve molecular complete remission (CR) and are randomized to the experimental arm receive three cycles of Blinatumomab plus chemotherapy, while patients in the standard arm or with molecular failure or intermediate response have an indication for SCT. The trial includes randomization to different treatments and a non-randomized Blinatumomab treatment for suboptimal responders. During the study, participants will be monitored for overall survival up to four years from randomization. Molecular evaluations for BCR-ABL1 are performed to guide treatment decisions, and safety is closely observed. Patients must consent to participate in a registry and agree to contraception requirements if applicable. Clinical assessments include performance status, blood tests, and cardiac monitoring. The study involves multiple centers and aims to gather long-term data on survival outcomes and treatment effectiveness.

This research focuses on adult patients with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) and related myeloid neoplasms. It aims to register all patients treated at approximately 80-90 sites in Germany and Austria, capturing comprehensive data on patient characteristics, family history, biological disease features, and clinical outcomes. The study also seeks to analyze genetic markers related to the disease and evaluate treatment responses and survival outcomes over an extended period. Patients enrolled in the study will have their disease-related genetic markers analyzed rapidly to inform treatment recommendations. Biosamples such as bone marrow, blood, plasma, skin biopsy, fingernails, hair, sputum, or urine will be collected and stored for further analysis. The study intends to assess measurable residual disease using various methods and correlate biological markers with clinical outcomes. Participants will be observed for up to 10 years, during which researchers will monitor event-free survival, relapse-free survival, cumulative incidence of relapse and death, overall survival, and quality of life. Treatment decisions, response to therapy, and geographical representation will also be recorded. Data collection includes clinical assessments and storage of biosamples, with ongoing evaluation of disease progression and patient outcomes throughout the study period.

Researchers are evaluating the effectiveness and safety of a subcutaneous cladribine treatment for patients with hairy cell leukemia who need therapy. This study focuses on patients who are either untreated or have only been pretreated with alpha-interferon. It aims to assess remission rates four months after treatment and whether a second cycle benefits those with a non-optimal response, defined by residual disease or partial remission. Participants receive cladribine 0.14 mg/kg as a subcutaneous bolus injection once daily for five consecutive days. If the response after the first cycle is not optimal, patients may receive a second cycle of the drug to improve their remission status. This treatment approach is being studied in a Phase 2/3 clinical trial setting. During the study, remission status is evaluated four months after the first treatment cycle. Patients undergo assessments to detect residual disease in bone marrow and peripheral blood. Researchers monitor the rate of complete remissions and any treatment-related toxicities. The overall health, laboratory tests, and disease markers are regularly checked throughout the study period to ensure safety and to measure the treatment's impact.