Salamanca

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are evaluating the efficacy, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis, a condition characterized by skin thickening and other systemic symptoms. This Phase 2 study compares ianalumab to a placebo to understand its impact on this disease, aiming to provide new treatment options for affected individuals. The study is sponsored by Novartis Pharmaceuticals and employs a randomized, double-blind design to ensure reliable results. Participants receive either ianalumab or placebo through subcutaneous injections during the initial 52-week treatment period. After this, all participants enter a second 52-week open-label phase where they receive ianalumab. Following treatment, there is a post-treatment follow-up lasting at least 20 weeks and up to 2 years to monitor long-term effects. The study includes a screening period lasting up to 6 weeks before treatment begins. Throughout the study, participants undergo regular assessments including measuring response based on the rCRISS25 scale at Week 52, lung function tests, skin scoring, and disability index evaluations. Blood samples are taken periodically to measure drug levels and antibodies. Safety is closely monitored through adverse event reporting up to Week 208. The total participation time can extend over several years including treatment and follow-up phases.

Researchers are studying new treatments for follicular lymphoma FL, a type of cancer affecting the lymphatic system. This trial evaluates the safety and effectiveness of a new immunotherapy called MK-1045 combined with rituximab, compared to the standard treatment of rituximab plus chemotherapy. The study aims to see if MK-1045 with rituximab can better control the cancer, help it go away, and extend the time patients live without their disease worsening. Participants in this trial receive MK-1045 through weekly intravenous infusions at increasing doses for up to about 12 months, alongside rituximab infusions every 4 weeks for up to 6 months. The comparison group receives physician-chosen chemotherapy treatments combined with rituximab over similar periods. Different chemotherapy options include bendamustine or combinations of cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone. The study is divided into two parts Part 1 focuses on finding the right MK-1045 dose and safety, and Part 2 compares MK-1045 plus rituximab to standard chemotherapy plus rituximab. Throughout the study, participants undergo regular evaluations including scans to measure cancer size and tests to monitor safety and drug levels. Researchers track side effects, treatment tolerability, cancer response, and quality of life using questionnaires. The main outcomes include adverse events, response rates, and progression-free survival over several years. The trial lasts multiple years with monitoring up to about 5 years to understand long-term effects and benefits of the treatments.

Researchers are investigating new treatments for people aged 12 and older with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia B-ALL. This trial compares an experimental immunotherapy called MK-1045 to a standard immunotherapy called blinatumomab. The study aims to find out if MK-1045 leads to more patients having no cancer cells in their bone marrow and if it can help patients live longer than with blinatumomab. The study has two parts. Part 1 focuses on finding the best dose of MK-1045, with participants receiving either a lower or higher dose once a week for up to 13 cycles, each cycle lasting between 28 and 42 days. Participants receiving blinatumomab get it on days 1, 8, 15, and 22 of each 42-day cycle. At the end of Part 1, participants may choose to change treatments. Part 2 compares the effectiveness and safety of MK-1045 at the recommended dose versus blinatumomab. Participants will be closely monitored through bone marrow tests and other assessments to determine their response to treatment, including remission status and survival over up to seven years. Researchers will track side effects, treatment discontinuation, and long-term outcomes. The study includes regular visits for treatment and monitoring throughout the cycles and follow-up periods.

Primary immune thrombocytopenia ITP is a condition where the immune system mistakenly destroys platelets, leading to a lower number of platelets and increased risk of bruising or bleeding. This Phase 3 study evaluates the long-term safety, tolerability, and effectiveness of mezagitamab in adults with chronic primary ITP. The study also investigates how the body processes mezagitamab over an extended period. Participants who completed previous mezagitamab studies TAK-079-3002 or TAK-079-1004 will be invited to join this continuation trial. Eligible participants may receive mezagitamab injections on demand, with treatment courses repeated as needed based on specific criteria and the investigators clinical judgment. The treatment is administered subcutaneously. During the study, participants will visit the clinic several times for assessments. Researchers will monitor safety by tracking treatment-emergent adverse events, and evaluate effectiveness through platelet response and remission rates. Measurements of drug levels and antibodies will also be taken. The study may last up to approximately 108 weeks, allowing detailed long-term follow-up.

This research aims to gather long-term safety and effectiveness information for people treated with ibrutinib, a medicine taken by mouth that blocks a specific enzyme called brutons tyrosine kinase. The study focuses on participants who previously took part in ibrutinib studies that have finished and are still receiving ibrutinib treatment, continuing to benefit from it. It is an open-label study, meaning both participants and researchers know the treatment being given. Participants will continue taking ibrutinib capsules daily at the dose they were given in their prior study until the doctor decides the treatment is no longer helpful due to disease progression or side effects, the participant chooses to stop, other treatment options become available, or the study ends. Safety will be monitored throughout, and effectiveness data may be combined with previous study results. No formal testing of hypotheses is planned in this extension. During the study, participants will be regularly monitored for safety and disease status. The main outcome is the number of participants experiencing side effects within 30 days after the last ibrutinib dose or before starting another cancer therapy. Participants may continue treatment until alternative access to ibrutinib is arranged or the study ends, which is planned for December 2029. Researchers will collect ongoing data to understand the long-term effects of ibrutinib treatment.

This study focuses on participants who have previously been treated with ciltacabtagene autoleucel cilta-cel, an autologous CAR-T therapy targeting B-cell maturation antigen BCMA used in multiple myeloma. The purpose is to collect long-term follow-up data to understand delayed adverse events and the long-term safety profile of cilta-cel over a period of up to 15 years after the last dose. Participants were originally treated in company-sponsored clinical trials evaluating cilta-cel. No treatment is administered during this follow-up study. Participants will be observed in two phases the first phase covers the initial 5 years after their last cilta-cel dose, and the second phase covers years 6 through 15 post-treatment. The study includes yearly safety evaluations involving review of adverse events, laboratory tests, and physical examinations including neurological assessments. Participants will be followed up at least once per year for up to 15 years to monitor for new or worsening medical conditions such as malignancies, neurological or autoimmune disorders, hematologic disorders, infections, and serious adverse events. The research team will also assess laboratory markers related to the CAR-T therapy, such as lentivirus presence and CAR transgene levels. This extended monitoring aims to provide a comprehensive safety profile of cilta-cel over the long term.

This research investigates ASTX030, a combination of azacitidine and cedazuridine, given alone or with venetoclax for people with myeloid neoplasms and acute myeloid leukemia AML. The study includes multiple phases, from early dose-finding stages to larger randomized trials, evaluating the safety, pharmacokinetics, and effectiveness of ASTX030 compared to standard subcutaneous azacitidine. It aims to understand how these treatments work in participants with myelodysplastic syndromes MDS, chronic myelomonocytic leukemia CMML, and AML over approximately eight years. The study involves several treatment arms early phases focus on dose escalation and expansion of oral ASTX030 later phases compare oral ASTX030 to subcutaneous azacitidine in randomized crossover designs. Combination therapy arms test ASTX030 plus venetoclax against azacitidine plus venetoclax with specific dosing schedules over 28-day cycles. Participants may switch treatments after initial cycles. Treatments include oral tablets, capsules, and injections, with some doses taken in a fasted or fed state. Participants will undergo regular cycles of treatment with detailed monitoring including blood tests to measure drug levels and responses, assessments of side effects, and evaluations of disease status. Researchers will track outcomes like drug exposure, response rates, survival, and safety over months to years. This includes measuring DNA methylation changes, transfusion independence, and adverse events. The study is open to adults and includes ongoing safety and effectiveness follow-up.

This trial studies adults aged 50 to under 80 with mild or moderate calcific aortic valve stenosis and elevated lipoproteina levels. Researchers are assessing the safety, tolerability, and ability of pelacarsen TQJ230 given once monthly by injection to slow the progression of this heart valve condition. The study compares pelacarsen to a placebo in a randomized, double-blind design. Participants receive either pelacarsen 80 mg or a matching placebo as a subcutaneous injection monthly. They continue treatment and monitoring for up to 36 months to observe changes in heart valve narrowing and calcium buildup. The study also tracks lipoproteina levels and clinical heart-related events during this period. Throughout the study, participants will have regular assessments including imaging to measure aortic valve function and calcium score, blood tests for lipoproteina, and monitoring for safety. The main outcomes analyzed after 36 months include changes in valve jet velocity and calcium score, alongside clinical events. Participants remain under medical care while being observed for any effects of the study drug or placebo.

Researchers are studying bleximenib, an oral drug, in participants with acute leukemia to find the best dose and evaluate its safety and effectiveness. The study includes Phase 1 dose escalation to find recommended doses and Phase 1 dose expansion and Phase 2 to assess safety, tolerability, and anti-leukemia activity. Participants include both pediatric and adult patients with relapsed or refractory acute leukemia, especially those with specific genetic alterations. In Phase 1 Part 1, participants receive increasing doses of bleximenib orally to identify recommended doses based on tolerance. In Phase 1 Part 2, participants receive bleximenib at these doses to further evaluate safety. Phase 2 participants take the recommended dose to study the drugs effect on leukemia. The study monitors participants up to 4 years and 9 months for safety and treatment response. Participants will undergo assessments including monitoring adverse events, dose-limiting toxicities, and treatment responses. Blood tests will measure drug levels and leukemia remission rates. Safety and efficacy are tracked throughout treatment and follow-up, with a focus on remission rates and survival outcomes. The total study duration extends to September 2030, allowing long-term evaluation of bleximenib.