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Researchers are evaluating the effectiveness and safety of pirtobrutinib in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study focuses on two parts: Part 1 tests three different doses of pirtobrutinib in participants who have had 1 to 3 prior treatments, including a covalent Bruton tyrosine kinase (BTK) inhibitor. Part 2 evaluates pirtobrutinib alone in participants who have not received prior treatment but have a specific genetic deletion called 17p. This is a phase 2, open-label, randomized study. Pirtobrutinib is given orally to participants in both study parts. Participants in Part 1 receive one of three dose levels, while those in Part 2 receive pirtobrutinib monotherapy. Part 1 participation lasts about 3 years, and Part 2 participation can last up to 2 years. The study compares the effects of different doses and treatment histories to better understand pirtobrutinib’s impact on CLL/SLL. Throughout the study, researchers monitor participants' overall response to treatment from the start up to 3 years. They assess safety and side effects, and participants are required to be able to swallow oral medication and have a performance status that allows them to participate. The study includes regular evaluations to determine how well the treatment controls the disease and to track any adverse events over the course of the study periods.

Glioblastoma (GBM) is the most common and aggressive brain tumor, affecting about 600 patients annually in Belgium. Despite treatments including surgery, radiotherapy, and chemotherapy, survival remains limited, with most patients living 12-18 months and only 5% surviving beyond 5 years. The BELGICA trial aims to determine if a more focused radiotherapy approach can reduce side effects and improve quality of life for patients with GBM. This trial compares two radiotherapy approaches: one with a smaller clinical target volume (CTV) margin of 10mm and the other with the standard margin of 15mm around the tumor or tumor bed. Reducing the CTV margin is expected to decrease the amount of healthy brain tissue exposed to radiation, potentially lowering treatment toxicity without compromising tumor control. Participants will be monitored from randomization until the study ends to assess overall survival. Researchers will also evaluate treatment side effects and quality of life. Eligibility requires adults with newly diagnosed glioblastoma who are suitable for chemoradiotherapy. Assessments include clinical evaluations and MRI scans, while safety and side effects are carefully tracked throughout the study.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

Researchers are investigating the use of elacestrant compared to standard endocrine therapy in patients with estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer who have a relapse detected by circulating tumor DNA (ctDNA). This international, multi-center, randomized, open-label phase III trial aims to determine if elacestrant offers a benefit over current endocrine treatments in this group of patients without distant metastases. The study includes a lengthy ctDNA screening phase to identify eligible participants and monitor their disease status over time. The study begins with a ctDNA screening phase, where patients receive standard adjuvant endocrine therapy such as tamoxifen, letrozole, anastrozole, or exemestane, and have blood collected every six months for ctDNA testing until about 5.7 years after enrollment ends. Those who test positive for ctDNA and show no distant metastasis on imaging will be randomized within four weeks to continue their current endocrine therapy or switch to elacestrant taken orally at 400 mg daily. Treatment duration varies based on prior endocrine therapy exposure, ranging from two to seven years. After treatment, further care is at the physician's discretion. Participants will have frequent follow-up visits with ctDNA testing at weeks 4 and 16 post-randomization and every 16 weeks thereafter for up to three years. Imaging studies including mammograms, bone scans, and CT scans will be conducted regularly to monitor for distant metastases or new cancers. The main outcome measured is distant metastasis-free survival, assessed up to 6.25 years following the first patient enrollment. The study ends when all patients complete their visits or discontinue for reasons such as withdrawal, loss to follow-up, or death, and data is fully analyzed and finalized.

Researchers are evaluating a medicine called elranatamab for the treatment of multiple myeloma (MM), a type of cancer. This study focuses on people aged 18 or older who have MM that has returned or not responded to previous treatments, including prior use of an anti-CD38 antibody and lenalidomide. The goal is to compare elranatamab to other common combination therapies that include 2 to 3 different MM medicines. This is a Phase 3 study to learn about the safety and effectiveness of elranatamab compared to these other treatments. Participants will be randomly assigned to receive either elranatamab or a combination therapy selected by the study doctor. Elranatamab is given as a shot under the skin at the study clinic about once a week, which may later reduce in frequency. The combination therapy options include medicines taken by mouth and given either as shots under the skin or through a needle in the vein at the clinic. The combination medicines used may be elotuzumab, pomalidomide, dexamethasone, bortezomib, or carfilzomib, depending on the chosen treatment plan. Participants may continue their assigned treatment until their MM stops responding. During the study, participants will visit the clinic regularly for monitoring and evaluation. Researchers will track how well the treatments work by measuring progression-free survival and will watch for any side effects or safety concerns. Follow-up will continue after treatment ends through phone calls or visits. The study may last up to about 5 years to fully assess the outcomes of the treatments.

Researchers are evaluating treatments for patients with hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer that has a PIK3CA mutation. This Phase 3 study compares the effectiveness and safety of RLY-2608 combined with fulvestrant versus capivasertib combined with fulvestrant. The study focuses on patients whose cancer returned or worsened after treatment with a CDK4/6 inhibitor. Participants will receive either RLY-2608 taken orally twice daily every day in 28-day cycles or capivasertib taken orally twice daily on days 1 through 4 each week within a 28-day cycle. All participants will also receive fulvestrant by intramuscular injection on day 1 and day 15 of the first cycle, then on day 1 of each following 28-day cycle. Treatment continues until disease progression or other criteria are met. During the study, researchers will monitor participants regularly to assess progression-free survival, which is the time from starting treatment until cancer progression or death. Assessments include radiographic imaging based on RECIST v1.1 criteria and safety evaluations. The study duration may extend up to approximately 77 months, allowing for long-term monitoring of treatment effects and safety.

Researchers are evaluating the safety and effectiveness of Lacutamab, a monoclonal anti-KIR3DL2 antibody, in patients with relapsed or refractory KIR3DL2-positive Peripheral T Cell Lymphoma (PTCL). This phase II, open-label, multicenter, randomized, non-comparative study includes several PTCL subtypes such as PTCL-NOS, PTCL-TFH (including AITL and follicular T-cell lymphoma), ALCL, ATL, HSTL, EATL, MEITL, NKT, and ANKL. The study design uses an unbalanced randomization (2:1) favoring the experimental arm to confirm assumptions made for sample size calculation without directly comparing arms. Participants receive treatment with either Lacutamab combined with GemOx (Gemcitabine and Oxaliplatin) or GemOx alone. Lacutamab is given intravenously at 750 mg, while Gemcitabine and Oxaliplatin are dosed at 1000 mg/m² and 100 mg/m², respectively. The study evaluates responses over a planned follow-up period, with no mention of additional extension or crossover phases. Throughout the study, participants undergo CT scans to assess disease progression, with the primary outcome being median modified progression-free survival measured over 5 years. Safety and efficacy outcomes are monitored regularly, while participants provide informed consent and comply with specific eligibility criteria related to disease status, prior treatments, and health conditions. The study includes monitoring for adverse events and requires contraception use for participants of childbearing potential during and after treatment.

Researchers are conducting a phase III, randomized, open-label, international trial to compare the effectiveness and safety of mosunetuzumab combined with lenalidomide versus an anti-CD20 monoclonal antibody plus chemotherapy. The study focuses on patients with previously untreated Follicular Lymphoma International Prognostic Index (FLIPI) 2-5 follicular lymphoma. This trial includes patients needing treatment based on disease characteristics and symptoms. It aims to assess progression-free survival and overall survival over a long-term period. Participants are divided into two groups. The experimental group receives mosunetuzumab in a step-up dosing schedule with cycles lasting from 3 to 8 weeks, combined with lenalidomide taken daily during specific cycles. The control group receives anti-CD20 monoclonal antibody with either CHOP chemotherapy or bendamustine chemotherapy over several cycles, followed by maintenance therapy lasting up to 30 months. The study disallows switching between groups. The total study duration is about 10 years, including screening, treatment, safety follow-up, and survival follow-up. During the study, patients undergo screening lasting up to 6 weeks before starting treatment. Assessments include evaluations at specific months during treatment to check response and safety. After treatment, patients are followed every 3 months for 2 years, then every 6 months for 3 years, and yearly thereafter until the study ends. Researchers monitor progression-free survival events assessed by an independent review committee. Participants are also evaluated for laboratory and heart function, and must adhere to visit schedules and protocol requirements throughout the study.