Meschede

Researchers are evaluating treatments for patients with high-risk chronic lymphocytic leukemia CLL, a type of blood cancer that is aggressive and currently incurable. This phase 3, open-label, multicenter, randomized study aims to compare the effectiveness of a triple drug combination acalabrutinib, obinutuzumab, and venetoclax against a double combination obinutuzumab and venetoclax in prolonging progression-free survival PFS for patients with specific high-risk genetic features such as 17p-deletion, TP53 mutation, complex karyotype, or unmutated IGHV gene status. The study addresses a crucial medical need for better treatments in this difficult-to-treat group. Participants will be randomly assigned to one of two treatment groups. One group receives the triple combination of acalabrutinib, obinutuzumab, and venetoclax, while the other group receives obinutuzumab plus venetoclax. Obinutuzumab is given as intravenous infusions on specific days across six cycles. Venetoclax is taken orally with a carefully planned dose escalation and maintenance over 12 cycles. Acalabrutinib is administered orally twice daily during cycles 15 to 24. The study explores whether adding acalabrutinib improves outcomes by using these fixed-duration, chemotherapy-free regimens. Throughout the study, participants will undergo regular assessments to monitor response and safety, including checks for minimal residual disease MRD and overall survival. These evaluations occur up to 50 months after the first patient is enrolled. Researchers will also track progression-free survival, complete and overall response rates, event-free survival, duration of response, and time to next treatment. Safety monitoring and laboratory tests will be performed as part of study visits. The total study participation is expected to last several years to capture long-term outcomes for this high-risk patient population.

This research aims to evaluate the effectiveness of luspatercept in adults with very low, low, or intermediate risk myelodysplastic syndromes MDS who have anemia but do not require blood transfusions and have not been treated with erythropoiesis-stimulating agents ESA. It focuses on patients who are transfusion-independent and have symptomatic anemia, studying the response to treatment in this specific group. All participants receive luspatercept administered as a subcutaneous injection at a dose of 1.75 mg per kg of body weight every 21 days. This treatment continues for 24 weeks initially, and for those who respond by week 25, therapy may extend for up to 1.5 years or until loss of response. This is a single-arm, open-label phase II study without a placebo group. Participants will have assessments at regular intervals, including blood tests and bone marrow sampling, to monitor blood cell counts and treatment response. The main outcome is erythroid response measured after eight treatment cycles each cycle is 21 days. Secondary outcomes include the duration of response, time to response, neutrophil and platelet responses, safety monitoring for adverse effects, and quality of life evaluations using validated questionnaires. The study lasts up to 48 months, including long-term follow-up.

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.

Researchers are evaluating maintenance therapies for patients with newly diagnosed multiple myeloma who have undergone induction therapy and autologous stem cell transplantation ASCT. The study compares a combination of iberdomide and isatuximab with iberdomide alone to determine if adding isatuximab reduces measurable myeloma cells in the bone marrow after two years. This is a multicenter, randomized, open phase III trial building on prior treatments from the GMMG-HD8DSMM XIX trial or similar regimens. Participants are randomly assigned to one of two groups. One group receives oral iberdomide alone for 39 cycles, each lasting 29 days, with dexamethasone added during the first cycle. The other group receives the same iberdomide regimen plus subcutaneous isatuximab injections using a wearable injector system, with dexamethasone also given in the first cycle. Treatment continues for up to 36 months. Randomization considers factors like minimal residual disease MRD status and the number of transplantations. During the study, participants will undergo bone marrow assessments to measure MRD using next-generation flow cytometry. Researchers will monitor progression-free survival, overall survival, response rates, and quality of life using validated questionnaires. Safety and treatment effects will be followed for up to five years after randomization. Participants will have regular evaluations including laboratory tests and clinical assessments throughout the maintenance period and follow-up.

This research aims to evaluate the addition of venetoclax to standard induction and consolidation chemotherapy in adults newly diagnosed with acute myeloid leukemia AML or myelodysplastic syndrome with excess blasts-2 MDS-EB-2. It is a randomized, placebo-controlled, double-blind phase 3 clinical trial preceded by a dose-escalation feasibility phase to establish the venetoclax dose. The study is conducted across multiple centers and sponsored by the University of Ulm. Participants first undergo a feasibility run-in phase where venetoclax dosing is determined. Then, eligible patients are randomly assigned to receive either intensive chemotherapy combined with venetoclax or with a placebo. Treatment includes two cycles of induction chemotherapy followed by consolidation therapy based on initial randomization and established protocols. Patients achieving complete remission or certain other response states continue consolidation, and some may undergo allogeneic stem cell transplantation or other treatments depending on clinical factors. During the study, participants receive detailed evaluations including assessments of treatment safety and effectiveness. Researchers monitor event-free survival, dose-limiting toxicities, remission rates, relapse, survival, and quality of life using questionnaires and laboratory testing. Treatment adherence and safety are closely tracked. The study follows participants until at least 16 months after the last patient is enrolled, with some outcome measures extending to 28 months, to gather comprehensive data on treatment impact and patient health.

Researchers are conducting a registry study involving adult patients diagnosed with acute myeloid leukemia AML and related myeloid neoplasms, including newly diagnosed or relapsedrefractory cases. The study aims to collect comprehensive data on patient characteristics, family history, biological disease profiles, and clinical outcomes. It also focuses on analyzing disease-related genetic markers and the impact of measurable residual disease MRD using various methods. The study does not involve specific treatments but collects data and biological samples such as bone marrow, blood, plasma, and normal tissue including skin biopsies and other specimens. This observational study enrolls patients from around 80 to 90 sites in Germany and Austria. Patients treatment responses, decisions, and outcomes are tracked over time. Participants are observed for up to 10 years, during which researchers gather information on treatment response, survival, relapse rates, quality of life, and genetic markers. The study includes assessments of event-free survival, relapse-free survival, cumulative incidence of relapse and death, and overall survival. Patient consent is required for registration, data storage, and biobanking of specimens for analysis throughout the observation period.