Deggendorf

Researchers are evaluating the effectiveness of avapritinib BLU-285 in treating people with indolent systemic mastocytosis ISM who have symptoms not well controlled by other treatments. This non-interventional study aims to fill gaps in understanding the natural history and management of ISM in real-world settings in Germany. Each participant will be followed for up to 24 months to observe treatment outcomes. Participants will receive avapritinib as an oral tablet prescribed by their healthcare provider, following standard treatment guidelines. The study does not assign treatment but observes participants who are starting avapritinib as part of their usual care. This approach allows researchers to gather data on how avapritinib is used and its effects in typical clinical practice. During the study, participants will undergo assessments including questionnaires to measure quality of life and mastocytosis symptoms at multiple time points up to 24 months. Researchers will collect information on demographics, medical history, medication changes, hospital visits, and safety events such as anaphylaxis. The main outcome is the change in quality of life measured at 6 months, with ongoing monitoring throughout the study period.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating the combination of Surovatamig AZD0486, a fully human bispecific monoclonal IgG4 antibody, plus rituximab versus standard immunochemotherapy regimens in adults with untreated follicular lymphoma FL. This global, randomized, open-label Phase III study aims to assess the efficacy, safety, and added benefit of this combination compared to investigator-chosen standard treatments. The study includes a safety run-in and a Phase III portion with three treatment arms. The study has two parts first, a Safety Run-in to determine the recommended Phase III dose RP3D of Surovatamig combined with rituximab second, a Phase III comparison of Surovatamig plus rituximab two dosing schedules against one of three standard chemoimmunotherapy regimens chosen by the investigator R-CVP, R-CHOP, or B-R, all followed by rituximab maintenance. Participants are assigned to one of these three arms to evaluate treatment effects. Participants will be monitored for up to 10 years, with assessments including adverse event tracking, dose adjustments, and efficacy measures such as response rates, progression-free survival, and overall survival. Evaluations involve physical exams, laboratory tests, and imaging to measure disease activity and safety. The study aims to gather long-term data on treatment impact and safety in this patient population.

Researchers are conducting a Phase III, randomized, open-label multicenter study to evaluate the effectiveness and safety of giredestrant compared with fulvestrant. Both drugs are combined with the investigators choice of a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib in participants with estrogen receptor-positive ER, HER2-negative advanced breast cancer who have become resistant to prior adjuvant endocrine therapy. Participants will be randomly assigned to one of two groups one group will receive giredestrant 30 mg orally daily on Days 1-28 of each 28-day cycle, while the other will receive fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and Day 1 of subsequent 28-day cycles. Both groups will also receive a CDK46 inhibitor chosen by the investigator, with dosing schedules depending on the specific inhibitor selected. Preperimenopausal women and men will receive a luteinizing hormone-releasing hormone LHRH agonist during treatment. Participants will be assessed for progression-free survival over up to 5 years, with additional measures including overall survival, response rates, duration of response, clinical benefit, and quality of life. Safety will be monitored through adverse event reporting, vital signs, and laboratory tests during treatment and up to 28 days after the last dose. The study is led by Hoffmann-La Roche and aims to provide detailed information on the treatments effects in this patient population.

Researchers are evaluating the effectiveness and safety of two fixed-duration treatment combinations for adults with previously untreated chronic lymphocytic leukemia CLL. The study compares sonrotoclax plus zanubrutinib with venetoclax plus acalabrutinib to determine which regimen may better manage this condition. This Phase 3 trial aims to provide insights into these oral therapies for CLL patients needing initial treatment. Participants will be randomly assigned to receive either sonrotoclax and zanubrutinib or venetoclax and acalabrutinib. Both treatment groups will follow a fixed duration of therapy, after which participants will be observed without active treatment. The study drugs are taken orally, and the treatment period is followed by a monitoring phase to evaluate ongoing health. During the study, participants will undergo evaluations including imaging tests to measure disease status and assessments of bone marrow and organ function. Researchers will track progression-free survival and minimal residual disease levels up to about 70 months. Other outcomes such as overall survival, response rates, adverse events, and quality of life will also be monitored. The total study duration extends until November 2031, offering long-term follow-up for participants.

Researchers are evaluating the addition of letrozole, an aromatase inhibitor, to the standard maintenance therapy in women diagnosed with estrogen-receptor ER positive epithelial ovarian cancer, including fallopian tube and primary peritoneal cancer. This study focuses on both low and high grade serous or endometrioid ovarian cancers at FIGO Stage II-IV, whose cancer has not progressed after primary surgery and platinum-based chemotherapy. The main goal is to determine if letrozole can increase progression-free survival compared to the current standard maintenance treatment with placebo. Participants are randomly assigned to receive either letrozole 2.5 mg daily or a placebo tablet once daily for up to five years or until toxicity symptoms or disease progression occur. This randomized, double-blinded, multicenter phase III trial involves 540 eligible women who will be monitored throughout the treatment period. The study also includes a sub-study focusing on low grade ovarian cancer LOGOS. Treatment adherence and tolerability will be assessed during regular visits. Participants will undergo health assessments including blood tests, physical and gynecological exams, and possibly imaging during routine follow-ups every 12 weeks for the first two years, then every 24 weeks for three additional years. Quality of life will be evaluated using specific questionnaires, and participants will wear an activity tracker for one week before visits. Researchers will measure progression-free survival as the primary outcome and also evaluate overall survival, time to next treatment, and quality-adjusted survival. Follow-up data will be collected for up to 12 years, including up to seven years after treatment ends to monitor long-term outcomes.

Researchers are collecting real-world data in Germany to better understand how patients with non-squamous metastatic non-small cell lung cancer NSQ mNSCLC, including certain cases of large cell neuroendocrine carcinoma, respond to a combination of tremelimumab, durvalumab, and platinum-based chemotherapy TDC. The study focuses on the effectiveness of this treatment in relation to specific genetic mutations and protein expressions such as KRAS, STK11, KEAP1, TP53, TTF-1, and PD-L1. This observational study aims to improve knowledge about biomarker-guided treatment strategies for distinct patient subgroups with high medical needs. The study follows patients who are starting first-line treatment with TDC as prescribed by current marketing authorizations. Researchers will observe and record outcomes without altering the treatment plan. The study includes molecular testing such as Next Generation Sequencing for gene mutations and protein expression analyses initiated according to institutional standards. Women who can become pregnant must use effective contraception during and for three months after durvalumab treatment. Participants will be monitored over time for up to two years to assess overall survival rates, treatment responses, progression-free survival, and safety through adverse event collection. Data will be gathered from routine clinical practice visits and medical records. The main measurement is the two-year overall survival rate in the total population and in subgroups with specific gene mutations. This study helps track how well treatments work and their safety in everyday medical settings.

Researchers are exploring the experiences of parents who have lost a child during pregnancy or birth. This study aims to develop treatment recommendations for healthcare professionals on how to support these parents. It follows a participatory and co-creative design, involving affected parents as part of the research team to ensure their voices guide the process. The study includes several steps first, workshops and focus groups will be held to identify the main needs of parents after child loss. Then, narrative interviews will be conducted to gain a deeper understanding of these experiences. Finally, the findings will be summarized and translated into practical treatment recommendations for healthcare professionals using a Delphi approach. Participants will share their experiences and needs during pregnancy and up to seven days after birth. Data will be collected through interviews and group discussions. The researchers will analyze this information to understand parents perspectives and develop supportive care guidelines. The study involves voluntary participation and focuses on parents who have experienced child loss within the past 12 months, lasting until December 2026.

Researchers are investigating the effects of additional chemotherapy treatment after surgery or ablation in patients with metastatic colorectal cancer whose tumor lesions have been definitively treated. This phase III, open-label, randomized, controlled trial aims to compare the effectiveness, quality of life, and safety of mFOLFOXIRImFOLFOX-6 chemotherapy against active follow-up without additional chemotherapy. The study also includes a translational research component to analyze tumor biopsies and blood samples for disease relapse markers. Patients are assigned randomly in a 21 ratio to receive either active chemotherapy mFOLFOXIRI, mFOLFOX6, FOLFIRI, or CAPOX for up to six months or structured follow-up without chemotherapy. Chemotherapy regimens involve intravenous infusions and oral medications administered in cycles every two or three weeks, with a maximum of 12 cycles for most treatments. After treatment or follow-up, participants continue with structured monitoring for up to five years. Participants undergo re-assessments every three months during the first two years, including CT or MRI scans of the thorax and abdomen, blood tests, and quality of life evaluations to detect disease relapse. After two years without relapse, follow-up intervals extend to every six months. The primary outcome measured is progression-free survival at 24 months, with secondary outcomes including overall survival, lesion control, adverse events, and quality of life monitored for up to five years following randomization.

Researchers are studying patients with breast cancer, focusing on those with metastatic disease who typically have the poorest outlook. The trial aims to improve treatment decisions and quality of care by analyzing tumor characteristics. Although national guidelines recommend molecular reassessment of metastatic tumors, biopsies are rare due to invasiveness, so the study explores blood-based methods to assess tumor features and their relation to treatment outcomes and health economics. The study involves two groups about 3,500 patients with locally advanced or metastatic breast cancer receiving any line of treatment, and approximately 10,000 patients with early breast cancer undergoing neoadjuvant or adjuvant therapy regardless of regimen. Blood samples will be collected during routine blood draws to analyze tumor molecular characteristics and biomarkers for progression and survival. Participants will be followed with assessments including quality of life, therapy adherence, depression factors, and adverse events at study entry and regularly up to 60 months. The study will measure progression-free survival in metastatic breast cancer and disease-free survival in early breast cancer, along with overall survival and health economic outcomes. Results of molecular testing will be shared with patients at study end, providing comprehensive data to support improved breast cancer care.