Palencia

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

Researchers are evaluating the effectiveness and safety of subcutaneous immunotherapy in patients aged 12 to 65 who have mild to moderate rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, caused by sensitivity to grass and olive pollen. This randomized, double-blind, placebo-controlled phase 3 trial aims to study allergy treatments to improve symptoms and reduce medication use over one year. Participants are randomly assigned to one of three groups one receiving 10,000 TUmL MG01 plus 10,000 TUmL T517, another receiving 30,000 TUmL MG01 plus 10,000 TUmL T517, and a placebo group receiving the same solution without active ingredients. The allergen extracts come from a mixture of grasses and olive pollen, administered through subcutaneous injections. Treatment lasts for one year, evaluating different doses compared to placebo. During the study, participants will regularly record symptoms and medication use using a smartphone app. Researchers will monitor combined symptoms and medication scores as the primary outcome, along with medication-free days, symptom-free days, asthma exacerbations, quality of life tests for rhinitis and asthma, and immune response measures. Safety is closely followed through adverse reaction monitoring and immunological and security parameters over the 12-month treatment period.

Researchers are evaluating the safety and effectiveness of subcutaneous immunotherapy in patients aged 12 to 65 who have rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, and who are sensitive to cupressaceae and grass pollen. This phase 3, multicenter, randomized, double-blinded, placebo-controlled trial aims to better understand treatment options for allergy symptoms related to these pollens. Participants will be randomly assigned to one of three groups two groups receiving different doses of a purified and polymerized allergen extract from grasses and cupressaceae mixed with aluminum hydroxide, and one placebo group receiving a similar solution without active ingredients. The treatment will be given by subcutaneous injections and will last for 18 months. The study will monitor symptoms and medication use during the specific pollen seasons for cupressaceae January to March and grasses May to June. Throughout the trial, participants will record their symptoms and medication intake using an electronic diary via a smartphone. Researchers will assess combined symptom and medication scores as the primary outcome, along with various secondary measures such as symptom-free days, medication-free days, asthma and rhinitis symptom scores, quality of life, immunological parameters, and safety. The total participation time for each subject is 18 months, during which their health and response to treatment will be closely monitored.

Researchers are conducting a long-term observational study to collect information from patients diagnosed with early-stage invasive breast cancer. These patients were previously part of neoadjuvant or adjuvant clinical trials conducted by the GEICAM group, starting from 1998. The study aims to evaluate the long-term effects and outcomes of breast cancer treatments over an extended follow-up period. The study includes patients who completed follow-up in the original GEICAM trials and will continue to monitor them for approximately 30 years. This extended observation allows researchers to assess long-term event-free survival and disease-free survival, along with overall survival, providing valuable insights into the durability of treatment effects and potential late effects. Participants will be followed regularly during this period, with data collected to track their health status and cancer outcomes. The study gathers vital information useful for healthcare professionals, hospital managers, patients, and society to better understand long-term needs and treatment impacts in early-stage invasive breast cancer. The total participation duration can be up to 30 years from the start of the study.

Inflammatory bowel disease IBD, including ulcerative colitis UC and Crohns disease CD, involves chronic inflammation affecting the digestive tract with periods of flare-ups. This study evaluates the real-world effectiveness and safety of granulocytapheresis GMA using the Adacolumn device in adult patients with UC or CD. GMA selectively removes inflammatory cells from the blood to reduce inflammation and is considered as an alternative or complementary treatment to corticosteroids and biological therapies in IBD management. Participants will receive GMA treatment with Adacolumn, typically following the standard regimen of one session per week for five weeks. In some cases, induction regimens with two sessions per week or maintenance regimens with one to two sessions per month may be used. The study is noninterventional and conducted across about 30 sites, aiming to enroll approximately 350 patients. Treatment use and regimens will be observed according to routine clinical practice without interfering with patient care. Patients will be followed through up to four visits baseline, and follow-ups at about 1 month, 6 months, and 12 months after the last induction session. Data collection includes clinical remission rates, steroid use, adverse events, quality of life assessments, and biomarker changes. All assessments coincide with routine care visits. The primary outcome is the proportion of patients achieving steroid-free remission at six months, with additional secondary outcomes evaluating remission rates, treatment regimens, safety, and quality of life over 12 months.

Researchers are conducting a national, multicenter observational study called SOGUG-PRINCIS to collect and analyze data on patients with genitourinary cancers treated with recently approved drugs under routine clinical practice in Spain. This study is both retrospective and prospective, aiming to validate real-world effectiveness of these drugs and support future funding decisions. It will serve as a registry where new subprojects will open whenever new drugs receive authorization. The study follows patients who have started treatment with specific drugs funded by the Spanish National Health System, including darolutamide combined with androgen deprivation therapy and docetaxel for hormone-sensitive prostate cancer, adjuvant nivolumab after surgery for urothelial carcinoma, and enfortumab vedotin for urothelial carcinoma. All treatments follow their approved dosing and administration guidelines and standard clinical practice. Participants progress will be monitored through routine data collection to evaluate outcomes such as progression-free survival at 18 months, relapse-free survival at 24 months, and overall survival at 12 months after starting treatment. Data will be gathered from patients treated at participating centers, with follow-up continuing as per routine care. The study does not intervene in treatment decisions, which are made independently before enrollment.

Researchers are studying adults aged 18 to 60 years with Philadelphia chromosome-negative acute lymphoblastic leukemia Ph-negative ALL. The study evaluates treatment outcomes based on measurable residual disease MRD status and genetic testing done at the start. The goal is to tailor therapy after initial consolidation to improve survival and remission rates. Patients initially receive a four-drug induction chemotherapy regimen including vincristine, prednisone, pegylated asparaginase, and daunorubicin. Those who do not respond may receive a second induction with fludarabine, cytarabine, G-CSF, and idarubicin. Patients with good MRD clearance and favorable genetics continue with early and delayed consolidation, reinduction, and maintenance chemotherapy using pediatric-type protocols. Others may proceed to allogeneic hematopoietic stem cell transplantation alloHSCT. Participants will undergo regular assessments of MRD after induction and consolidation phases, along with monitoring for complete remission at 4 to 8 weeks. Researchers will track overall survival for 3 years. Safety and treatment responses are evaluated throughout, with ongoing follow-up. The total study duration includes treatment periods and observation to assess long-term outcomes under the guidance of the PETHEMA Foundation.