Eschweiler

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

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 investigating whether adding intismeran autogene to pembrolizumab after surgery helps people with non-small cell lung cancer NSCLC stay cancer-free longer compared to pembrolizumab with a placebo. This study focuses on participants whose tumors did not fully respond to treatment before surgery. It is a phase 3 trial aiming to evaluate treatment options for resectable stage II to IIIB N2 NSCLC patients who did not achieve a complete pathological response after neoadjuvant therapy. Participants receive neoadjuvant treatment with pembrolizumab and chemotherapy drugs such as cisplatin, carboplatin, pemetrexed, gemcitabine, or paclitaxel, given by intravenous infusion every three weeks for up to four cycles. After surgery, participants receive adjuvant treatment with pembrolizumab every six weeks combined with either intismeran autogene or placebo by intramuscular injection every three weeks, for up to seven and nine doses respectively. During the study, participants undergo treatment cycles, surgery, and follow-up assessments. Researchers evaluate disease-free survival over approximately 97 months and monitor overall survival, metastasis-free survival, quality of life, physical and role functioning, and adverse events up to around 129 months. The study includes regular evaluations and safety monitoring to understand the impact of these treatments on long-term outcomes and participant well-being.

Researchers are studying the use of ribociclib, a CDK46 inhibitor, in women with early hormone receptor-positive HR and HER2-negative breast cancer who are at intermediate risk of cancer recurrence. The study aims to see if patients can avoid chemotherapy, which has significant side effects, by using ribociclib along with hormone therapy after surgery. This phase III trial builds on the NATALEE study, which showed that ribociclib added to hormone therapy improved survival free of invasive disease in similar patients. Participants will be randomly assigned to one of two groups one receiving ribociclib plus endocrine hormone therapy, and the other receiving chemotherapy followed by ribociclib and endocrine therapy. Ribociclib treatment lasts for three years, and chemotherapy is given before starting ribociclib and hormone treatment. The trial aims to compare the outcomes of chemotherapy de-escalation versus standard treatment in this patient group. During the study, participants will attend scheduled visits for treatment and monitoring, including laboratory tests, heart monitoring with ECG, and questionnaires about their quality of life. Researchers will track invasive breast cancer-free survival and other outcomes such as overall survival and treatment side effects for up to 12 years. Safety and quality of life assessments will continue during and after treatment to evaluate the long-term effects and benefits of the treatment approaches.

Researchers are evaluating the safety, effectiveness, and quality of life for combining Abemaciclib with either an Aromatase Inhibitor or Fulvestrant in women with metastatic hormone receptor-positive, HER2-negative breast cancer. This Phase IV trial focuses on both pre- and postmenopausal patients receiving first-line treatment. A digital health app called CANKADO will be used to track side effects and patient-reported outcomes daily, alongside standard documentation. The study also aims to explore biomarkers to better understand treatment responses and resistance. Participants will receive either Abemaciclib combined with an Aromatase Inhibitor Anastrozole, Letrozole, or Exemestane taken orally twice daily plus daily Aromatase Inhibitor tablets every 24 hours in 28-day cycles, or Abemaciclib with Fulvestrant which is given as an injection on specific days within 28-day cycles. The two treatment groups are experimental and non-randomized, with no masking. The trial includes monitoring for side effects and quality of life throughout treatment. During the study, participants will regularly report side effects and global health status using questionnaires at multiple time points up to 24 months, including specialized breast cancer quality of life modules. Researchers will assess progression-free survival up to 48 months, as well as adverse events, hospitalizations, clinical benefit rate, overall survival, and tumor response. The use of the CANKADO app for side effect reporting is strongly recommended but not mandatory. Participants will be followed for safety and outcomes throughout the trial duration.

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.

Researchers are evaluating whether patients with hormone-receptor positive, HER2-negative early breast cancer HRHER2- eBC who have intermediate to high risk of recurrence may benefit from an initial 5-year treatment with elacestrant, with or without a CDK 46 inhibitor, followed by standard endocrine therapy ET for an additional 0 to 2.5 years. This is compared to the current standard of care ET lasting between 5 and 7.5 years, with or without CDK 46 inhibitors. The study is designed for patients identified by genomic tests like Oncotype DX and response to preoperative endocrine therapy, aiming to improve long-term survival by targeting resistance mechanisms such as ESR1 mutations. Participants are randomly assigned to one of two groups one receiving elacestrant orally for 5 years, possibly combined with ribociclib a CDK 46 inhibitor for 3 years if indicated, and the other receiving standard endocrine treatments for 5 to 10 years with optional CDK 46 inhibitors as decided by their doctor. The treatments are evaluated in a parallel study design. The trial builds on previous findings in metastatic breast cancer and early breast cancer studies exploring endocrine therapy responses and genomic risk assessments. Throughout the study, participants undergo regular clinical assessments, including tumor pathology reviews, laboratory tests, and electrocardiograms to monitor safety and treatment effects. Researchers measure outcomes such as 5-year invasive disease-free survival and other survival metrics. Participants must comply with contraception requirements and be followed for treatment adherence and safety until study completion, which is planned for up to 2033.

Triple negative breast cancer TNBC is a type of breast cancer that lacks certain receptors and tends to have a poor prognosis and aggressive behavior. The study focuses on patients with low-risk, early-stage TNBC stage I-II node-negative who generally have better outcomes, but still face significant clinical challenges. Researchers are evaluating neoadjuvant therapies to improve treatment strategies for this group, especially comparing sacituzumab govitecan alone versus its combination with pembrolizumab. Participants will receive neoadjuvant treatment for 12 weeks, either sacituzumab govitecan alone or combined with pembrolizumab. Sacituzumab govitecan is given intravenously at 10 mgkg on Days 1 and 8 every 21 days, while pembrolizumab is administered intravenously at 200 mg every three weeks. Depending on their response after 12 weeks, some patients may continue treatment for an additional 6 weeks before surgery. Patients who achieve a complete response may not require further systemic treatment, while those with residual disease may receive additional chemotherapy as decided by their investigator. Throughout the study, participants will be closely monitored with various assessments including pathological evaluation at surgery and invasive disease-free survival measured after three years. Other outcomes include overall survival and quality of life assessments. Safety and response will be regularly evaluated to guide treatment decisions. The trial aims to enroll adult women with early-stage TNBC and will continue through September 2029, with detailed follow-up planned to capture long-term outcomes.

Researchers are evaluating the best neoadjuvant therapy for patients with less advanced HER2-positive early breast cancer EBC. This Phase 2 trial focuses on improving treatment outcomes by comparing trastuzumab-deruxtecan T-DXd with standard chemotherapy combined with trastuzumab and pertuzumab. The study targets patients with low to intermediate risk HER2 EBC, aiming to show higher rates of complete tumor response and excellent survival outcomes. Participants receive different treatment regimens depending on their risk group and assigned study arm. Treatments include 12 or 18 weeks of T-DXd alone or combined with standard chemotherapy, trastuzumab, and pertuzumab. After neoadjuvant treatment, post-neoadjuvant therapy with T-DXd or standard care continues for up to one year, with adjustments based on tumor response. Some patients may receive additional chemotherapy depending on residual tumor burden. During the study, participants undergo regular evaluations including tumor response assessments and safety monitoring for adverse drug reactions. Key outcomes measured are pathological complete response rate after neoadjuvant therapy and distant disease-free survival after three years. Researchers also track various survival outcomes, quality of life, and treatment-related side effects over time. Participants are followed until study completion in 2030, with detailed monitoring throughout the treatment and follow-up phases.