Idar Oberstein

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.

Researchers are collecting information on adults diagnosed with Acute Lymphoblastic Leukemia ALL and related diseases like certain types of Non-Hodgkins Lymphoma. This observational registry gathers data from routine clinical care to support research and improve quality assurance. The study includes adults treated according to ALL or related treatment protocols, whether they are part of a clinical trial or not. This registry does not involve any specific treatments but collects detailed data on diagnosis, treatment, and outcomes. It prospectively gathers information on patient progress, including survival and remission rates, as well as biomaterial samples when available. The study monitors various types of leukemia and lymphoma subtypes treated under ALL protocols. Participants contribute by allowing their medical data and biomaterial to be collected and analyzed over time. Researchers track many outcomes such as overall survival, remission status, relapse rates, quality of life, and treatment-related side effects. Follow-up can extend up to 10 years, with ongoing evaluations to understand long-term health and treatment effects.

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.

Researchers are evaluating treatments for adults aged 18 to 65 with newly diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Ph ALL. This phase 2 multicenter trial, sponsored by Goethe University, aims to compare the current standard treatment of Imatinib plus low-dose chemotherapy with Ponatinib plus chemotherapy. It also seeks to explore different treatment strategies based on patients molecular response to therapy, including the use of Blinatumomab and the role of stem cell transplantation. Participants receive either Imatinib 600 mg once daily or Ponatinib 45 mg once daily reduced to 30 mg after induction, both combined with low-dose chemotherapy during induction and consolidation phases. Patients with a good molecular response are randomized to either end therapy with indication for stem cell transplantation or continue treatment with TKI, chemotherapy, and Blinatumomab. Those with poor molecular response receive Blinatumomab followed by end of therapy and transplantation indication. Stem cell transplantation itself is not part of the trial. During the study, participants undergo molecular evaluations for BCR-ABL1, regular monitoring of blood counts, and assessments of treatment response. Researchers measure overall survival in molecular complete remission patients receiving TKI-chemotherapy-Blinatumomab versus standard end of therapy with transplantation indication. Safety and remission rates are also tracked. The study involves follow-up for up to four years from randomization to assess long-term outcomes and treatment effects.

Researchers are evaluating the use of venetoclax in people with Chronic Lymphocytic Leukemia CLL in a real-life setting. This observational study aims to understand the effectiveness, health-related costs, and participant-reported outcomes for those receiving venetoclax alone or combined with rituximab, obinutuzumab, ibrutinib, or acalabrutinib as prescribed by their doctors according to local clinical practice and labels. Participants with CLL are observed while receiving venetoclax either as a single treatment or in combination with one of four other medications rituximab, obinutuzumab, ibrutinib, or acalabrutinib. The choice of treatment is determined by the physician and follows approved local guidelines. The study groups include those on venetoclax alone and those on venetoclax combined with each of the other drugs. During the study, participants responses to the treatment are monitored, focusing on the percentage achieving the best overall response within up to 12 months. Researchers also assess health economic costs and collect participant-reported outcomes. The study follows participants over time without changing their treatment and continues until December 2030, with data collected during regular care visits.