New Berlin

Researchers are evaluating whether eptinezumab can reduce the number of days with episodic migraine in children and adolescents aged 6 to 17 years. This Phase 3 clinical trial focuses on the preventive treatment of episodic migraine in pediatric participants using intravenous infusion. The study is randomized, double-blind, and placebo-controlled to compare the effects of different doses of eptinezumab with a placebo. Participants will be assigned to one of three groups a single intravenous infusion of eptinezumab 300 mg adjusted for weight, a single intravenous infusion of eptinezumab 100 mg adjusted for weight, or a single intravenous infusion of a placebo matching eptinezumab. The dosing occurs once, and the study monitors results over subsequent weeks. This design allows for comparison of the medication against placebo to evaluate treatment effects in this population. During the study, participants and their caregivers will complete headache diaries to document migraine and headache days. Researchers will assess changes in the number of monthly migraine days over 12 weeks, response rates to treatment, headache duration and intensity, acute medication use, and disability related to migraine using questionnaires like the Pediatric Migraine Disability Assessment PedMIDAS. Blood samples will be collected to measure drug concentrations and antibodies. Safety and efficacy are monitored throughout the study period, which concludes approximately 12 weeks after dosing.

Researchers are comparing two monoclonal antibody treatments, rituximab and mosunetuzumab, for adults with previously untreated follicular lymphoma that has a low tumor burden. The study aims to understand which treatment better controls disease progression and improves outcomes over time. Both drugs target cancer cells but work differently, and this phase III trial evaluates their effectiveness and safety. Participants are randomly assigned to one of two groups. One group receives rituximab intravenously and subcutaneously in cycles repeating every 56 days for up to five cycles unless the disease progresses or side effects become unacceptable. The other group receives mosunetuzumab subcutaneously in cycles repeating every 21 days for up to eight cycles under similar conditions. During treatment, patients undergo CT or PETCT scans and blood tests to monitor their disease and health. After completing the treatment phase, participants are followed with visits every six months for five years, then annually up to ten years. Researchers collect imaging and blood samples during and after treatment to assess progression-free survival and other health outcomes, including overall survival and treatment side effects. This long-term follow-up helps understand the treatments lasting effects and safety.

Researchers are evaluating how sentinel lymph node SLN biopsy surgery compares to standard elective neck dissection END in treating patients with early-stage oral cavity squamous cell carcinoma OCSCC. This phase IIIII trial focuses on patient-reported neck and shoulder function, quality of life, and disease-free survival to determine if SLN biopsy works better or at least as well as the standard surgery while potentially causing less impairment. Participants are randomly assigned to one of two groups. One group receives an imaging agent injection followed by planar imaging and SPECTCT scans over 1 to 2 hours, then undergoes SLN biopsy surgery. The other group undergoes the standard neck dissection surgery. Both groups have FDG PETCT, CT, andor chest x-rays at screening and during follow-up. The trial includes detailed assessments of surgical outcomes, complications, and diagnostic imaging performance. Participants complete patient-reported outcome questionnaires on neck and shoulder function and quality of life before surgery, and at intervals up to 12 months after surgery. Imaging tests and chest x-rays are done at screening and during follow-up visits scheduled at 3 weeks post-surgery, then every 3 months in the first year, every 4 months in the second year, every 6 months in the third year, and annually thereafter. Researchers measure disease-free survival, overall survival, treatment toxicity, and hospital stay length over an extended follow-up of up to 11 years.

This research aims to evaluate how well inotuzumab ozogamicin and blinatumomab, with or without ponatinib, work in treating adults with newly diagnosed, recurrent, or refractory CD22-positive B-lineage acute lymphoblastic leukemia ALL. The study focuses on patients with Philadelphia chromosome-negative or positive B-cell ALL, including those who are older or transplant-ineligible. It also seeks to assess safety, tolerability, survival outcomes, response rates, and molecular markers related to treatment effectiveness. Participants are assigned to one of three cohorts based on their disease status and Philadelphia chromosome presence. Cohorts 1 and 2 receive inotuzumab ozogamicin intravenously on specific days, followed by blinatumomab infusions, while cohort 3 receives a combination of ponatinib orally, inotuzumab ozogamicin, blinatumomab, dexamethasone, methotrexate, and other treatments over multiple courses. Treatment courses vary in length from 21 to 126 days, with maintenance ponatinib for 24 months in cohort 3. Bone marrow aspirations, biopsies, lumbar punctures, and sample collections are performed throughout the study. During the study, participants undergo regular assessments including blood and cerebrospinal fluid sample collections, bone marrow evaluations, and monitoring for treatment response and safety. Researchers measure event-free survival, overall survival, relapse-free survival, response rates, minimal residual disease negativity, and molecular response over periods up to 10 years. After treatment completion, participants are followed every 3 months for 3 years, then every 6 months up to 10 years to monitor long-term outcomes.

The Master Screening and Reassessment Protocol MSRP for the NCI MyeloMATCH clinical trials focuses on patients with myeloid cancers, including acute myeloid leukemia AML and myelodysplastic syndrome MDS. The study evaluates the use of a screening tool and specific laboratory tests, including rapid genetic testing of bone marrow and blood, to better identify biomarkers that can guide treatment decisions. The goal is to improve the ability to assign participants to targeted treatment studies or to continue standard care through a Tier Advancement Pathway TAP. Participants undergo bone marrow aspiration and blood collection for biomarker testing. Based on their mutational profiles, patients may be assigned to specific treatment substudies testing therapies tailored to their cancer or placed on TAP if no targeted treatment is available. The study includes various treatment regimens involving drugs such as azacitidine, venetoclax, daunorubicin, and others administered via intravenous, oral, or subcutaneous routes. Screening also includes echocardiography or multigated acquisition scans to assess heart function. Throughout the study, participants have ongoing bone marrow biopsies and aspirations, blood sample collections, and additional imaging such as chest x-rays, PET, or CT scans as needed. Researchers monitor treatment assignment timing, treatment responses, adverse events, minimal residual disease, and patient survival. The study aims to maintain access to investigational treatments and collect specimens for translational research. The total duration varies by treatment assignment and disease progression, with continuous monitoring throughout.

This trial evaluates whether a shorter duration of HER2-targeted therapy is as effective as the standard length for treating early-stage HER2-positive breast cancer in patients who had a complete response after preoperative chemotherapy with trastuzumab. The study focuses on comparing 6 months versus 12 months of combined neoadjuvant and adjuvant HER2 blockade and also assesses quality of life and safety outcomes. The trial aims to determine if shorter treatment can maintain similar recurrence-free survival and reduce side effects. Participants are randomly assigned to receive trastuzumab and possibly pertuzumab either intravenously or subcutaneously every 21 days. One group receives treatment for up to 17 cycles about 12 months, while the other group receives treatment for up to 9 cycles about 6 months, as long as no disease progression or unacceptable toxicity occurs. Throughout the trial, patients undergo heart function tests echocardiography or MUGA and breast imaging mammography, ultrasound, or MRI. Optional blood and tissue samples may be collected for additional studies. Participants are followed for recurrence and survival for up to 10 years after treatment begins, with check-ins every 6 months for the first 5 years and then yearly afterward. The study measures recurrence-free survival, overall survival, local and distant cancer recurrence, and patient-reported quality of life using specific questionnaires. It also monitors serious side effects and symptoms like diarrhea, fatigue, and rash. This comprehensive follow-up helps evaluate long-term outcomes and treatment impact.

This trial studies patients with newly diagnosed grade 3 astrocytoma that have mutations in the IDH1 or IDH2 genes. It evaluates whether adding the enzyme inhibitor vorasidenib to the usual chemotherapy drug temozolomide after radiation can improve outcomes compared to temozolomide with a placebo. This phase III study focuses on progression-free survival and other measures of treatment effectiveness and safety in these patients. Participants receive radiation therapy using advanced techniques such as intensity-modulated radiation therapy, volume modulated arc therapy, pencil beam scanning, or intensity-modulated proton therapy once daily Monday through Friday for 33 sessions. Starting four weeks after radiation, patients are randomly assigned to receive temozolomide with either vorasidenib or placebo taken orally in 28-day cycles, with temozolomide given on days 1-5 and the study drug or placebo on days 1-28, for up to 12 months. Blood samples and MRI scans are collected throughout the treatment period. After completing study treatment, participants will be followed regularly for up to 10 years to monitor progression-free survival and overall survival. Follow-ups occur every three months for the first two years, every four months for the next two years, and then every six months thereafter. Researchers also assess response rates, safety, quality of life, seizure control, and other health outcomes during treatment and follow-up to better understand the impact of vorasidenib combined with temozolomide.

Researchers are evaluating zanubrutinib treatment approaches in older adults with mantle cell lymphoma MCL who have not received prior therapy. This phase III trial compares continuous zanubrutinib treatment versus intermittent treatment restarted upon disease progression after initial complete remission following zanubrutinib plus rituximab therapy. The study aims to find if stopping treatment and resuming later is as safe and effective as ongoing treatment, potentially reducing clinical and financial burdens for older patients. Patients begin with induction therapy receiving zanubrutinib orally twice daily and rituximab intravenously every 28 days for up to six cycles, unless disease progresses or toxicity occurs. Those achieving complete remission are randomized to either continuous zanubrutinib maintenance until progression Arm A or observation until progression followed by zanubrutinib restarted until second progression Arm B. Throughout the trial, patients may undergo bone marrow biopsies, PETCT or CT scans, and optional blood sample collections. Other procedures like endoscopies may be done as needed. Participants attend regular assessments including imaging and laboratory tests to monitor disease status and treatment effects. Researchers measure progression-free survival times, overall survival, response rates, adverse events, and quality of life outcomes with questionnaires and patient-reported symptom assessments. After study treatment ends, patients have follow-up visits every six months for up to ten years to monitor long-term outcomes and safety.

Researchers are evaluating whether adjusting the timing of doses for the prostate cancer drug Lutetium 177 Lu PSMA RLT can improve quality of life without reducing lifespan in patients with hormone-resistant prostate cancer that may have spread nearby or to distant sites. This phase III trial compares the standard dosing schedule with an adaptive dosing approach based on disease activity. The study focuses on patients whose cancer cells express a protein called PSMA, which the drug targets. Participants first receive two doses of Lutetium 177 Lu PSMA RLT intravenously every 6 weeks. Those showing sufficient PSA decline then enter a randomized phase where one group continues standard dosing every 6 weeks for up to four more doses, while the other group has treatment delayed and resumed adaptively based on PSA levels and clinical signs. Throughout the trial, patients undergo blood tests, CT scans, bone scans, PSMA PET scans during screening, and MRI if indicated. Treatment continues unless disease progresses or unacceptable side effects occur. During the study, participants have regular PSA monitoring, blood samples collected, and imaging tests to assess disease status and side effects. Quality of life, overall survival, pain severity, and treatment toxicity are measured up to several years. After treatment, patients are followed every 12 weeks until disease progression and then every 6 months for up to 5 years. The study aims to understand if adaptive dosing can maintain survival while improving life quality for men with advanced prostate cancer.

Researchers are evaluating whether the drugs mosunetuzumab and polatuzumab vedotin can provide benefits for patients with diffuse large B-cell lymphoma or grade 3b follicular lymphoma that has returned or not responded to treatment. This study focuses on patients who have already received chemotherapy with fludarabine and cyclophosphamide, followed by CAR T-cell therapy. The goal is to determine if adding these drugs after previous treatments may better control or shrink the cancer. Participants first receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by one of three CAR T-cell therapies given by infusion tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel. After this, participants are randomly assigned to one of four groups receiving mosunetuzumab alone, polatuzumab vedotin alone, both drugs together, or observation without further drug treatment. Those in the observation group who experience disease progression within 12 months may switch to receive both drugs. Throughout the study, patients undergo PET-CT or CT scans and provide blood and tissue samples for research. Participants will be monitored regularly with imaging scans and laboratory tests to assess disease status and treatment effects. Researchers will measure progression-free survival, overall survival, remission rates, and treatment side effects up to two years. The study also includes collecting and banking tissue samples and PET-CT images for future research. The total length of involvement depends on individual timelines but includes treatment and follow-up periods extending up to two years or more.