Lewistown

This research aims to collect data and samples from patients who experience side effects from immunotherapy used in cancer treatment. The goal is to better understand, predict, prevent, and treat these immune-related side effects, including serious adverse events, rare infections, or accelerated tumor growth. This observational study is led by the Alliance for Clinical Trials in Oncology and focuses on patients treated with immuno-oncology therapies who have experienced significant immune-related adverse events. Participants provide tissue and blood samples, with optional stool samples for those experiencing colitis, within 72 hours of confirming a serious immune-related adverse event and again one month later. The study also includes a review of patients' medical records for up to one year. This approach helps establish a national biorepository of biospecimens and clinical data for future research. During the study, participants will undergo sample collection at two time points and have their medical history reviewed over a year. Researchers will monitor the establishment of the biorepository and collect clinical data to support future studies. This process aims to improve knowledge about immune-related side effects from immunotherapy and contribute to better patient care over time.

Researchers are evaluating treatments for younger patients with intermediate risk acute myeloid leukemia (AML) in this phase II MyeloMATCH trial. The study compares three treatment approaches: cytarabine with daunorubicin, cytarabine with daunorubicin plus venetoclax, and venetoclax with azacitidine. The goal is to determine if adding venetoclax improves the elimination of leukemia cells by measuring undetectable residual disease after treatment. Participants are randomly assigned to one of three treatment groups. The first group receives daunorubicin intravenously on days 2-4, cytarabine intravenously continuously on days 2-8, and venetoclax orally once daily on days 1-11, with possible reinduction cycles based on bone marrow assessments. The second group receives azacitidine intravenously or subcutaneously on days 1-7 or days 1-5 and 8-9 and venetoclax orally daily for 28 days, repeating cycles every 28 days for two cycles. The third group receives daunorubicin intravenously on days 1-3 and cytarabine intravenously continuously on days 1-7, with possible reinduction based on bone marrow results. Treatment continues unless disease progresses or unacceptable side effects occur. Participants undergo bone marrow aspirations and blood sample collections during the study and as needed. After treatment, follow-up visits occur at 4 weeks, then every 3 months for a year, every 6 months for the second year, and yearly afterward. Researchers measure the rate of undetectable measurable residual disease, treatment toxicities, remission rates, event-free survival, relapse-free survival, overall survival, and responses related to genetic findings. The total study duration includes treatment and long-term follow-up up to 10 years.

Researchers are investigating treatments for patients with high-risk smoldering multiple myeloma, a condition where abnormal plasma cells grow in the bone marrow but without symptoms. This phase III trial evaluates how well lenalidomide and dexamethasone work together, with or without the addition of daratumumab, an immunotherapy drug. The study aims to compare overall survival, progression-free survival, response rates, and quality of life between these two treatment approaches. Participants are randomly assigned to one of two treatment groups. One group receives daratumumab intravenously on a set schedule alongside oral lenalidomide daily and dexamethasone on specific days within repeated 28-day cycles, up to 24 cycles. The other group receives lenalidomide and dexamethasone on a similar schedule without daratumumab. Treatment continues until disease progression or unacceptable side effects occur. After treatment, patients are followed up for up to 15 years to monitor long-term outcomes. Throughout the study, participants undergo evaluations including blood and urine tests, bone marrow biopsies, and imaging scans such as FDG-PET/CT. Researchers assess treatment response, minimal residual disease status, safety, and quality of life using questionnaires. They also monitor treatment adherence and side effects, including infusion reactions. The main outcomes measured are overall survival and changes in quality of life. Safety and various laboratory and imaging markers are regularly reviewed to understand treatment effects and disease progression.

Researchers are evaluating the effects of two chemotherapy combinations, mFOLFIRINOX and mFOLFOX, with or without the immunotherapy drug nivolumab, for treating advanced, unresectable, or metastatic HER2 negative cancers of the esophagus, gastroesophageal junction, and stomach. This phase III trial aims to determine if overall survival improves with mFOLFIRINOX compared to mFOLFOX and to assess differences in progression-free survival, response rates, safety, and patient-reported outcomes. Participants are randomly assigned to one of two groups: one receives fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan intravenously, with nivolumab given as needed; the other group receives fluorouracil, leucovorin calcium, and oxaliplatin intravenously, also with nivolumab as indicated. Throughout the trial, patients undergo MRI and CT scans and may provide blood samples for additional research on markers like PD-L1 combined positive score and cell-free DNA. During the study, participants will have regular imaging scans and blood collections to monitor their cancer and treatment effects. Researchers will track overall survival for up to two years and monitor progression-free survival, tumor response, duration of response, and adverse events for up to three years. Patient-reported outcomes will be collected at baseline and throughout treatment cycles to assess tolerability and side effects.

Researchers are evaluating a Master Screening and Reassessment Protocol (MSRP) to improve how patients with myeloid cancers, such as acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), are matched to clinical trials or standard treatments. This study focuses on testing bone marrow and blood samples for biomarkers that may guide targeted therapies. The goal is to speed up and improve the assignment process to relevant treatment studies or to a Tier Advancement Pathway (TAP) for standard care. Participants undergo bone marrow aspiration and blood collection, which are tested rapidly to identify genetic markers. Based on these results, patients are assigned to specific treatment substudies tailored to their cancer's mutations or placed on TAP if no matching study is available. Treatments include various drug regimens delivered intravenously or by mouth, with cycles typically repeating every 21 or 28 days, depending on the specific therapy. Some substudies also include stem cell transplantation and maintenance therapies. Throughout the trial, participants have regular blood draws, bone marrow biopsies, and imaging tests such as echocardiograms, CT scans, and PET scans to monitor disease status and treatment effects. Researchers measure how quickly patients are assigned to treatments, track their response to therapies including minimal residual disease, and observe overall survival. The study continues for as long as patients remain on treatment or TAP, with ongoing specimen collection and safety monitoring.

Researchers are studying the relationship between low muscle mass (myopenia) at diagnosis and chemotherapy side effects in older adults newly diagnosed with advanced colorectal cancer. This prospective cohort study also investigates how genetic differences may influence the link between myopenia and chemotherapy toxicity, focusing on overall survival in this population receiving specific chemotherapy treatments. Participants in this observational study are older adults with metastatic colorectal cancer who are starting or recently started 5-Fluouracil (5-FU) based chemotherapy, alone or combined with other drugs like oxaliplatin, irinotecan, or immunotherapy. The study groups include adults aged 60-74 years and those 75 years or older. The study tracks chemotherapy toxicities over 6 months following treatment initiation. During the study, participants will be monitored for chemotherapy toxicities graded 3 to 5 and overall survival for up to one year. Researchers will collect information through questionnaires available in English or Spanish and assess the impact of muscle mass and genetics on treatment side effects and survival. The total participation time varies, with ongoing assessments during and after chemotherapy treatment.

Researchers are evaluating the effectiveness of radiation therapy compared to observation in patients with newly diagnosed grade II meningioma that has been completely removed by surgery. This phase III randomized trial aims to determine the clinical benefit of adding radiation after surgery, including effects on survival, neurocognitive function, patient quality of life, and tumor progression. The study also investigates biomarkers and pathology concordance to better understand treatment outcomes. Participants are randomly assigned to one of two groups. One group receives observation with regular MRI scans and blood sample collection, while the other group receives intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy five days a week for 6.5 to 7 weeks, totaling 33 treatment sessions, along with MRI and blood collection. Treatment continues unless the disease progresses or unacceptable side effects occur. After treatment, participants have follow-up visits at 3, 6, and 12 months, then every 6 months for two years, and yearly up to 10 years. During the study, participants undergo MRI scans, blood collection, and assessments of neurocognitive function and patient-reported outcomes. Researchers monitor progression-free survival as the primary outcome over up to 10 years, as well as overall survival, disease-specific survival, treatment side effects, and adherence to protocol. Biomarker studies and pathology reviews are also part of the evaluations. Total participation may last up to 10 years with regular check-ups to assess health and study endpoints.

Researchers are collecting data on patients with Epidermal Growth Factor Receptor (EGFR)-mutant Non-Small Cell Lung Cancer (NSCLC) who are treated outside of a clinical trial with standard care using osimertinib alone or combined with chemotherapy. The goal is to better understand the safety and effectiveness of these treatments as they are used in routine clinical practice. This is an observational study recruiting about 250 patients per treatment group, including those receiving osimertinib alone or osimertinib plus chemotherapy. Patients are treated according to standard medical care as determined by their doctors. One group receives osimertinib by mouth once daily, while the other group receives osimertinib plus chemotherapy, with chemotherapy type chosen by the treating physician. Treatment dosing and administration follow standard guidelines. The study records planned treatments at registration and observes outcomes without altering the care given. Participants will have clinical and imaging assessments as part of their usual care, with data collected on their health and treatment progress. Researchers will measure real-world progression-free survival, overall survival, and time to stopping osimertinib for up to three years. The study follows participants over time to monitor how they respond to therapy and to gather safety information.

Researchers are evaluating the addition of pembrolizumab, an immunotherapy drug, to usual chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival between different treatment approaches, including chemotherapy alone and chemotherapy combined with pembrolizumab. The study also assesses quality of life, side effects, and the impact of tumor markers on outcomes. Patients are randomly assigned to one of two active treatment groups. One group receives standard chemotherapy every 21 days for 4 cycles followed by pembrolizumab given intravenously every 21 days or every 6 weeks for up to 17 cycles. The other group receives chemotherapy combined with pembrolizumab during the initial 4 cycles, followed by pembrolizumab alone for additional cycles. Chemotherapy regimens include combinations of cisplatin, carboplatin, pemetrexed, gemcitabine, or paclitaxel. A previous group receiving chemotherapy alone followed by observation is closed. Participants undergo various assessments including echocardiograms, MRIs, CT scans, and blood sample collections during the trial. They complete quality of life questionnaires and are monitored regularly for disease recurrence, side effects, and survival for up to 10 years. Follow-up visits occur every 3 months for 2 years, then every 6 months for years 2 to 4, and annually thereafter, providing long-term monitoring of treatment effects and safety.

Researchers are evaluating different treatment combinations for adults aged 18 to 59 with newly diagnosed, high-risk acute myeloid leukemia (AML). This phase II trial compares the standard chemotherapy drugs cytarabine and daunorubicin with newer experimental regimens that include combinations with liposome-encapsulated daunorubicin-cytarabine and venetoclax, a drug that may block proteins helping cancer cells survive. The goal is to see which treatment best reduces measurable residual disease and improves remission rates in patients with hard-to-treat AML. Participants are randomly assigned to one of five treatment groups. One group receives the standard cytarabine and daunorubicin combination intravenously over 7 days. Other groups receive experimental treatments including cytarabine and daunorubicin with oral venetoclax, azacitidine with venetoclax, liposome-encapsulated daunorubicin-cytarabine alone, or combined with venetoclax. Treatments are given in cycles of 28 days, with some patients possibly receiving an additional cycle depending on their response and side effects. Before treatment, patients undergo heart function tests and during the trial, bone marrow aspirations and blood collections are regularly performed. During the study, participants are closely monitored through blood tests, bone marrow samples, and heart scans to assess treatment effects and side effects. After completing the study treatment, they have follow-up visits every month for the first year, then less frequently up to five years. Researchers measure outcomes such as remission rates, relapse times, survival, and adverse events. Specimens are also collected to support future research. This comprehensive monitoring aims to understand the benefits and risks of each treatment approach for high-risk AML patients.