New Berlin

This trial investigates whether eptinezumab can reduce the number of migraine days in children and teenagers aged 6 to 17 with episodic migraine. The study focuses on pediatric participants who have had migraine headaches for at least six months, aiming to evaluate the preventive treatment potential of this medication. This is a Phase 3 randomized, double-blind, placebo-controlled study designed to assess both the effectiveness and safety of eptinezumab given intravenously. Participants will receive either eptinezumab or a placebo, both administered as a solution through an infusion. The study includes a screening period where migraine and headache frequency are recorded using an electronic diary. The main measurement is the change from baseline in the average number of monthly migraine days over the first 12 weeks of treatment. During the study, participants and their caregivers will complete headache diaries to track migraine occurrences. Researchers will monitor migraine frequency and evaluate safety throughout the trial. The primary outcome is the difference in migraine days per month compared to the start of the study, assessed over the 12-week treatment period. This study helps understand how well eptinezumab may prevent episodic migraine in the pediatric population.

Researchers are evaluating the effectiveness of two different monoclonal antibody treatments, rituximab and mosunetuzumab, for patients with follicular lymphoma that has a low tumor burden. This is a phase III trial aiming to compare how well these treatments work in preventing disease progression, transformation to a more aggressive lymphoma, or death. The study also looks at overall survival, response rates, event-free survival, and the frequency and severity of side effects. Specimens will be collected and stored for future research. Participants are randomly assigned to one of two treatment groups. In the first group, patients receive rituximab intravenously on the first day and then rituximab combined with hyaluronidase subcutaneously on several days during a 56-day cycle, repeated for up to five cycles if the disease does not worsen or cause unacceptable side effects. In the second group, patients receive mosunetuzumab subcutaneously on several days during a 21-day cycle, repeated for up to eight cycles under the same conditions. Both groups undergo CT or PET/CT scans and blood sample collection during treatment and follow-up. After completing the treatment cycles, patients are followed every six months for five years and then yearly up to a total of 10 years to monitor their health and disease status. Researchers collect imaging results, blood tests, and other assessments to track progression-free survival, overall survival, treatment response, and safety. The study measures how long participants live without disease progression or transformation and records any treatment-related toxicities throughout the study period.

Researchers are studying early-stage oral cavity squamous cell carcinoma (OCSCC) to compare the effects of sentinel lymph node (SLN) biopsy surgery versus standard elective neck dissection (END). This phase II/III trial aims to evaluate patient-reported neck and shoulder function and quality of life after surgery, as well as disease-free survival. The study includes patients with specific early-stage oral cavity cancers and uses various imaging and diagnostic tools to guide treatment and assessment. Participants are randomly assigned to one of two groups. One group receives an imaging agent and undergoes planar imaging and SPECT/CT scans before having SLN biopsy surgery, which removes fewer lymph nodes by targeting those most likely affected by cancer. The other group undergoes standard END surgery, which removes many lymph nodes from the neck. Both groups receive additional imaging such as FDG PET/CT, CT, or chest x-rays during screening and follow-up. Throughout the study, participants complete patient-reported outcome questionnaires assessing neck and shoulder function and quality of life at multiple time points before and after surgery, including up to 12 months. Disease-free survival is monitored for up to 11 years to track cancer recurrence or death. Researchers also assess patterns of failure, overall survival, surgical toxicity, hospitalization length, and diagnostic accuracy of imaging. Follow-up includes visits at 3 weeks post-surgery, every 3 months for the first year, every 4 months in the second year, every 6 months in the third year, and yearly thereafter.

Researchers are evaluating how well inotuzumab ozogamicin and blinatumomab, with or without ponatinib, work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia (ALL). This includes patients with newly diagnosed, recurrent, or treatment-resistant (refractory) forms of the disease, both Philadelphia chromosome-negative and positive. This phase II trial aims to confirm tolerability, estimate survival rates, response rates, and assess safety and molecular responses in different patient cohorts. Participants are assigned to one of three cohorts based on their disease status and Philadelphia chromosome status. Treatments include intravenous inotuzumab ozogamicin and blinatumomab given in cycles over several weeks, with some groups also receiving daily oral ponatinib. Various courses of treatment are outlined, including induction, consolidation, maintenance, and extended therapy depending on response. Procedures such as bone marrow biopsies, lumbar punctures with cerebrospinal fluid collection, and blood draws are performed throughout the study. During the study, patients undergo regular assessments including bone marrow aspiration, blood tests, and lumbar punctures to monitor disease status and treatment effects. Researchers measure event-free survival, treatment completion, response rates, molecular responses, and safety outcomes over periods up to 10 years. Follow-up visits occur every three months for three years and then every six months up to ten years to monitor long-term outcomes and safety.

Researchers are evaluating a Master Screening and Reassessment Protocol (MSRP) called myeloMATCH for people with myeloid cancers such as acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). This Phase 2 study aims to improve how patients are matched to clinical trials or standard treatments by testing bone marrow and blood samples for specific biomarkers. These markers help doctors understand the cancer's characteristics and identify targeted treatments or assign patients to a standard of care treatment pathway called the Tier Advancement Pathway (TAP). Participants undergo bone marrow aspiration and blood collection for rapid genetic testing to identify mutations that guide treatment assignment. Based on these results, patients are placed into treatment substudies targeting their cancer type or, if no targetable mutation is found, into TAP to receive standard care with ongoing monitoring. The study includes multiple treatment arms with various drug regimens such as azacitidine, venetoclax, daunorubicin, cytarabine, and others, delivered through intravenous, subcutaneous, or oral routes. Some participants may receive hematopoietic stem cell transplants and conditioning therapies. Treatment cycles generally repeat every 21 to 28 days, with adjustments based on response and tolerance. Throughout the trial, participants undergo regular assessments including bone marrow biopsies, blood tests, imaging scans (such as chest x-rays, CT, PET, echocardiography, and MUGA scans), and specimen collection for translational medicine and biobanking. The study monitors treatment assignment timing, response rates, remission status, measurable residual disease, survival outcomes, and safety. Participants remain on study for ongoing reassessment and potential assignment to higher-tier treatments or TAP. The protocol requires informed consent and continues as long as disease progression or unacceptable toxicity does not occur.

Researchers are evaluating whether 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy is as effective as 12 months of the same treatment for patients with early-stage HER2-positive breast cancer who have no remaining invasive cancer after preoperative chemotherapy with trastuzumab. This phase III trial focuses on patients who achieved a pathologic complete response (pCR), aiming to assess recurrence-free survival and quality of life outcomes. The study also explores differences in side effects and survival among subgroups based on treatment delivery and hormone receptor status. Participants are randomly assigned to receive either 6 or 12 months of HER2-targeted therapy, including trastuzumab and possibly pertuzumab, administered intravenously or subcutaneously every 21 days. The treatment cycles continue up to 9 or 17 cycles respectively, unless disease progression or unacceptable side effects occur. Throughout the trial, patients undergo regular heart function tests (echocardiography or MUGA), breast imaging (mammography, ultrasound, or MRI), and may optionally provide blood and tissue samples. During the study, patients complete quality of life questionnaires and are monitored for cancer recurrence and side effects. Follow-up visits occur every 6 months for 5 years and then annually up to 10 years after registration. The main outcomes measured include time without cancer recurrence and patient-reported quality of life at 12 months. Safety and long-term effects of the different treatment durations are also assessed.

Researchers are evaluating whether continuous or intermittent treatment with zanubrutinib after achieving complete remission with rituximab is effective and safe for older adults with previously untreated mantle cell lymphoma (MCL). This phase III trial addresses the challenge of ongoing treatment burden and financial toxicity from indefinite zanubrutinib use by comparing two maintenance strategies in this patient population. Participants first receive induction therapy with oral zanubrutinib combined with intravenous rituximab. Those who reach complete remission are then randomly assigned to either continuous zanubrutinib treatment until disease progression (Arm A) or observation until disease progression followed by zanubrutinib retreatment until a second progression (Arm B). Throughout the trial, patients undergo various scans including PET/CT, CT, and MRI, as well as optional procedures like bone marrow biopsy, endoscopy, colonoscopy, and blood sample collection. During the study, researchers assess progression-free survival, overall survival, response rates, adverse events, and quality of life using patient-reported outcomes and functional assessments. Safety and effectiveness are monitored up to 10 years after randomization, with follow-up visits every six months after treatment completion. The trial also explores cognitive function and minimal residual disease to better understand treatment impact.

Researchers are evaluating whether adding mosunetuzumab and/or polatuzumab vedotin after chemotherapy and CAR T-cell therapy can better control or shrink recurrent or treatment-resistant diffuse large B-cell lymphoma and grade IIIb follicular lymphoma. This phase II trial focuses on patients who have previously received chemotherapy drugs fludarabine and cyclophosphamide followed by CAR T-cell therapies such as tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel. Mosunetuzumab is a monoclonal antibody that may block cancer cell growth, while polatuzumab vedotin is a targeted therapy combining an antibody with a chemotherapy drug to kill cancer cells. Participants first receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by one of the FDA-approved CAR T-cell products. After this, they are randomized into one of four groups: one receiving mosunetuzumab alone, one receiving polatuzumab vedotin alone, one receiving both drugs together, and one group under observation without additional therapy. Patients undergo PET-CT or CT scans and provide blood and tissue samples throughout the study to monitor their condition. During the trial, researchers monitor progression-free survival, overall survival, remission rates, and treatment-related side effects. Imaging tests like PET-CT and CT scans assess tumor response, while blood and tissue samples are collected for further study. Participants are followed for up to two years to evaluate disease progression or survival, and those in the observation group who experience progression may switch to the combined treatment. The study also banks specimens and imaging data for future research.

Researchers are evaluating treatments for patients with PD-L1 positive head and neck squamous cell carcinoma that has returned or persisted after initial improvement. This phase II trial compares adding chemotherapy with carboplatin and paclitaxel, or chemo-immunotherapy including cemiplimab, to the usual salvage surgery followed by radiation and cisplatin. The study aims to assess if these additions improve event-free survival and other outcomes in high-risk patients. Participants are randomly assigned to one of three groups: standard salvage surgery alone; chemotherapy with carboplatin and paclitaxel before surgery; or chemo-immunotherapy with carboplatin, paclitaxel, and cemiplimab before surgery. Post-surgery, patients with high-risk features receive radiation therapy daily for 6 weeks and weekly cisplatin during radiation. Imaging scans like CT and PET, along with optional blood samples, are collected throughout treatment. After treatment, patients are followed up regularly—first at 12 weeks or end of radiation, then every 3 months for 2 years, every 6 months for years 3 and 4, and annually afterward. Researchers monitor disease progression, treatment side effects, and survival outcomes up to 7 years. They also evaluate tumor response to therapy and surgical quality measures to understand long-term benefits and risks.

Researchers are evaluating whether adding docetaxel chemotherapy to the usual hormonal therapy and apalutamide treatment improves outcomes for men with prostate cancer that has spread to other parts of the body. This phase III trial focuses on men with metastatic castrate-sensitive prostate cancer and aims to assess overall survival, progression times, symptom control, and quality of life among other outcomes. The study also explores how genetic tumor changes and disease volume impact treatment effectiveness. Participants are randomly assigned to one of two groups. One group receives androgen deprivation therapy (ADT) and daily oral apalutamide, while the other group receives the same plus intravenous docetaxel every 21 days for up to six doses. Treatments are given in 12-week cycles as long as the disease does not worsen or side effects are unacceptable. Throughout the study, participants undergo imaging scans including CT, MRI, bone scan, and optionally PSMA PET scans, along with blood sample collection. After completing treatment, participants are followed every six months for up to ten years. Researchers monitor overall survival, time to disease progression, symptom changes, quality of life scores, and safety using various questionnaires and clinical assessments. The study also collects data on tumor markers and imaging to better understand treatment responses and disease characteristics over time.