Meschede

Researchers are evaluating treatments for patients with high risk chronic lymphocytic leukemia (CLL), a common and aggressive form of leukemia. This phase 3, open-label, randomized study aims to compare a triple combination therapy of acalabrutinib, obinutuzumab, and venetoclax (GAVe) against a double combination of obinutuzumab and venetoclax (GVe) to see which better prolongs progression-free survival (PFS). High risk CLL patients are identified by specific genetic risk factors such as 17p-deletion, TP53-mutation, complex karyotype, or unmutated IGHV gene status, which indicate a poorer prognosis and less response to chemotherapy. Participants receive fixed-duration treatments. The triple combination group receives obinutuzumab via intravenous infusion during cycles 1 through 6, venetoclax orally with a gradual dose ramp-up from cycle 1 to 12, and acalabrutinib orally twice daily during cycles 15 to 24. The comparison group receives obinutuzumab and venetoclax on the same schedules but without acalabrutinib. The study investigates how adding the BTK inhibitor acalabrutinib to the existing combination may improve outcomes by targeting different pathways and reducing early disease progression. During the study, participants are closely monitored for progression-free survival over 50 months after the first patient is included. Researchers assess clinical status, laboratory tests, and genetic markers to evaluate response and safety. The study also tracks liver and kidney function, infection status, and adverse events to ensure treatment tolerability. The total duration includes initial treatment cycles and extended follow-up to measure the long-term effectiveness of these therapies in high risk CLL patients.

This research focuses on patients with very low, low, or intermediate risk myelodysplastic syndromes (MDS) who have anemia but do not require blood transfusions and have not previously been treated with erythropoiesis-stimulating agents (ESA). The study aims to evaluate the effectiveness of luspatercept in these patients, including those with or without ring sideroblasts, in improving their anemia condition. This is a Phase II, open-label, single-arm study designed to explore the potential benefits of luspatercept in this specific group of MDS patients. All patients enrolled in the study will receive luspatercept injections at a dose of 1.75 mg/kg administered under the skin every three weeks on day 1 of each 21-day cycle. This treatment will continue for 24 weeks initially. Patients who show a positive erythroid response at week 25 will continue to receive the same dose of luspatercept until their response is lost or for a maximum expected duration of 18 months. Participants will be closely monitored through scheduled assessments including blood tests and bone marrow sampling during screening and treatment. The primary outcome measured is the erythroid response at the end of cycle 8, where each cycle lasts 21 days. Safety and treatment effectiveness will be evaluated throughout the study period, with ongoing follow-up to track patient outcomes and any adverse effects. The total participation duration varies depending on individual response to treatment.

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 evaluating maintenance therapies for patients with newly diagnosed multiple myeloma who have undergone induction therapy and autologous stem cell transplantation (ASCT). This phase III clinical trial compares a maintenance treatment combining iberdomide and isatuximab with iberdomide alone. The main goal is to see if adding isatuximab reduces the amount of myeloma cells in the bone marrow after two years. Participants are randomly assigned to one of two groups. One group receives 39 cycles of oral iberdomide, each cycle lasting 29 days. The other group receives the same iberdomide treatment plus subcutaneous isatuximab injections given on specific days during the first three cycles and then monthly from cycle four onward. Both groups receive dexamethasone during the first cycle. The study treatment continues for up to 36 months. During the study, participants undergo regular assessments including bone marrow tests to measure minimal residual disease, blood tests, and questionnaires to evaluate quality of life. Researchers monitor disease progression, response to treatment, and survival over time. The primary outcome is the level of minimal residual disease in the bone marrow 24 months after starting maintenance therapy. Secondary outcomes include progression-free survival, overall survival, response rates, and patient-reported quality of life measures.

Researchers are evaluating the use of venetoclax combined with induction and consolidation chemotherapy in adults newly diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndrome with excess blasts-2 (MDS-EB-2). This phase III, multicenter, double-blind, randomized, placebo-controlled study aims to establish the effectiveness and safety of adding venetoclax to standard chemotherapy compared to placebo. The study includes a feasibility run-in dose-escalation phase to determine the appropriate venetoclax dose for the main phase 3 trial. Eligible patients will first enter a dose-escalation phase if applicable, then be randomized to receive either venetoclax or placebo along with intensive chemotherapy. Treatment includes two induction chemotherapy cycles with cytarabine and daunorubicin, followed by consolidation chemotherapy based on age and response. Patients achieving complete remission or morphologic leukemia-free states may continue consolidation therapy. Some patients may also proceed to allogeneic stem cell transplantation based on institutional guidelines and individual factors. Participants will be closely monitored for events such as survival without leukemia relapse and treatment toxicities over 6 and 16 months. Safety assessments include tracking dose-limiting toxicities during the first treatment cycle. The study also involves molecular testing, kidney and liver function tests, and adherence to contraceptive measures for participants of childbearing potential. The total study participation duration varies based on treatment response and follow-up needs.

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.