Lymphoma

This research aims to evaluate the effectiveness and safety of a combination treatment using Selinexor, Pegaspargase, and Dexamethasone for patients with early-stage NKT-cell lymphoma. The study is designed as a Phase 1 and Phase 2 clinical trial and focuses on improving local disease control and overall prognosis in this specific type of lymphoma. Patients receive an oral regimen combining Selinexor, Pegaspargase, and Dexamethasone. Selinexor works by inhibiting nuclear export proteins that are overexpressed in malignant tumor cells, including viral mRNA such as EBV. This treatment is combined with sequential radiotherapy to potentially enhance outcomes. The study monitors the responses to this combined therapy in early-stage lymphoma. Participants will be involved in regular assessments to track tumor response and overall health. The primary outcome measured is the complete response rate CRR based on tumor volume reduction, evaluated up to 36 months from randomization. Safety and treatment effects will be closely monitored during the trial period, which runs from September 2024 through December 2026.

This research aims to understand how patients with cancer respond to COVID-19 vaccination by studying the levels of protective antibodies over time. The focus is on individuals with solid organ malignancies receiving various anti-cancer treatments such as chemotherapy, targeted therapy, and immunotherapy, as well as those who have been disease-free for at least six months. Since cancer patients were excluded from initial vaccine trials, this study seeks to fill knowledge gaps about vaccine safety and effectiveness in this group. Participants include cancer patients who are either undergoing active treatment or are disease-free for six months or more. They are grouped based on their treatment type chemotherapy, targeted therapy, immunotherapy, or disease-free status. The study involves monitoring antibody trends related to COVID-19 infection and vaccination at multiple time points over a 12-month period. During the study, researchers will collect blood samples to measure neutralizing and spike antibody levels every three months for up to one year. Participants will be followed to track their immune response depending on their cancer treatment and biological aging status. The study will also assess how antibody levels change over time and correlate with different treatments and patient characteristics. Safety and consent are carefully monitored throughout the trial.

Researchers are evaluating the potential usefulness of 18F-FAPI-04 positron emission tomographycomputed tomography PETCT and positron emission tomographymagnetic resonance imaging PETMR for diagnosing primary and metastatic cancer lesions, detecting recurrence, and assessing pathological response across various cancer types. The study is observational and aims to assess how well these imaging methods perform compared to standard diagnosis using histopathology and follow-up. Participants with different types of cancer undergo imaging with 18F-FAPI-04 PETCT and PETMR scans. The tracer 18F-FAPI-04 is injected into patients before the scans. Tumor uptake is measured by maximum standard uptake value SUVmax and tumor to background ratio TBR. The imaging results are compared using sensitivity, specificity, positive predictive value, negative predictive value, and accuracy to evaluate diagnostic performance. During the study, participants are assessed through these imaging procedures to monitor tumor presence, recurrence, or response to treatment. The primary outcome is the diagnostic performance evaluated over one year. The study includes participants aged 18 to 90 years and involves informed consent and ethical approval. The total duration and follow-up details are based on imaging and clinical evaluations to confirm findings.

Researchers are evaluating 18F-grazy-02 PETCT imaging to study its safety and usefulness in monitoring immunotherapy treatments for patients with lymphoma or solid tumors, including lung cancer and melanoma. This diagnostic trial involves adults aged 18 to 75 years and focuses on immunotherapy approaches such as immune checkpoint inhibition and CAR-T cell therapy. The study is conducted in an open-label format, meaning both researchers and participants know the treatment being administered. Participants will receive an intravenous injection of 18F-grazy-02 at a dose of 2.96-3.7 MBqkg body weight. After injection, a total-body PETCT scan using a uEXPLORER scanner will be performed to image granzyme B expression. This imaging process occurs during the study period, which includes phases 1 and 2, to assess both safety and early monitoring capability of this tracer with immunotherapy. During the trial, participants will undergo PETCT imaging procedures and clinical monitoring to assess adverse events and biodistribution of 18F-grazy-02 over one year. The study also evaluates the ability of this PET tracer to monitor immunotherapy responses over a longer period of three years. Participants will be assessed for their health status, including ECOG performance score and ability to complete imaging procedures. The total study duration extends until December 2028, ensuring comprehensive safety and clinical data collection.

Researchers are evaluating the use of 18F-Pentixafor PET imaging to improve the diagnosis, staging, and response evaluation of hematological malignancies such as multiple myeloma, leukemia, and lymphoma. This imaging method targets the CXCR-4 receptor, which is overexpressed in these tumors and is linked to tumor growth and poor prognosis. The study aims to assess how well 18F-Pentixafor PET performs compared to current imaging methods like 18F-FDG PET. Participants will receive a single intravenous injection of 18F-Pentixafor at a dose of 55 MBqkg. After 60 minutes, they will undergo either a PETCT or PETMR scan. This process allows for detailed imaging without special preparation. The study includes patients with suspected or confirmed hematological malignancies and involves only one imaging session per participant. During the study, researchers will monitor diagnostic accuracy and compare 18F-Pentixafor PETs performance with traditional 18F-FDG PET imaging. They will also assess disease activity using the Deauville Score over a period of up to 3-4 years. Participants will be involved in imaging procedures and may undergo biopsies if needed for diagnosis. The study will continue until December 2029, with an average follow-up of about 1.5 years for primary outcome assessment.

Researchers are evaluating a radioactive agent linked to an antibody called 211At-BC8-B10 followed by donor stem cell transplant for patients with high-risk acute leukemia or myelodysplastic syndrome that has returned or is not responding to treatment. This phase III trial studies the side effects and best dose of this treatment. The antibody may interfere with cancer cell growth, and the transplant aims to help the patients bone marrow produce healthy blood cells. Additional medications are given to help prevent complications like graft versus host disease. Participants receive a preparative regimen including an infusion of 211At-BC8-B10 over 6-8 hours on day -8, followed by chemotherapy drugs fludarabine and cyclophosphamide over several days. Total-body irradiation TBI is given on day -1. On day 0, patients undergo peripheral blood stem cell or bone marrow transplant. After transplant, patients receive medications cyclophosphamide, mycophenolate mofetil, and tacrolimus to reduce the risk of graft versus host disease. Granulocyte colony-stimulating factor G-CSF is started on day 5 to support white blood cell recovery. Throughout the study, patients undergo bone marrow biopsies, aspirations, and blood sample collections. They are followed up at day 100 and then at 6, 9, 12, 18, and 24 months after treatment. Researchers monitor side effects including dose-limiting toxicities, remission rates, engraftment success, donor chimerism, immune recovery, graft versus host disease, survival, and disease-free survival. Patient health and safety are regularly assessed during and after treatment.

Researchers are evaluating a new formulation of 64Cu-LLP2A, a drug used for PETCT imaging, in both healthy volunteers and patients with blood cancers such as multiple myeloma and low-grade lymphoma. This early phase study aims to confirm that the new formulation provides comparable human dosimetry to the previous formulation while expanding the patient population to include those with confirmed diagnoses or those who have undergone bone marrow transplant with suspected disease recurrence. Participants will receive the 64Cu-LLP2A drug followed by PETCT imaging at up to three different time points depending on the day of injection. Imaging includes multiple quick body scans shortly after injection, scans at 120-180 or 180-240 minutes post-injection, and a delayed scan 15-28 hours later. Some participants will also undergo a dynamic PETCT scan focused on a known target lesion for 60 minutes, followed by an additional whole-body scan. During the study, participants will be monitored for organ dosimetry and safety through adverse event tracking up to 7 days after administration. The quality of PET images will be assessed based on overall image quality, bone marrow uptake, and tumor-to-background ratios. Participants must lie still within the scanner for up to 75 minutes during imaging sessions. The study is expected to complete by March 2027.

This research aims to evaluate the use of a new imaging agent called 68Ga-ICAM-1pep in cancer patients undergoing radiotherapy. Researchers want to see if this agent can help predict the abscopal effect, a phenomenon where radiotherapy affects tumors outside the treated area. The study focuses on patients with various cancers such as lung, esophagus, and cervical cancer, and it is an early-phase clinical trial investigating this new approach. Participants will receive a single intravenous dose of 2.96 MBqkg of 68Ga-ICAM-1pep. PETCT scans will be performed about one hour after the injection. There are two groups patients who have not yet received radiotherapy and those who have completed radiotherapy. Imaging will be done before and during radiotherapy to observe tumor responses. During the study, participants will undergo PETCT scans covering from the head to the upper thigh. Researchers will measure the standardized uptake values SUVs of 68Ga-ICAM-1pep before treatment and monitor changes during radiotherapy, about 3 to 4 weeks after it begins. The study includes monitoring for compliance with imaging procedures and overall safety until the study ends in late 2025.

Researchers are evaluating the uptake characteristics of 68Ga-NYM096 PETCT imaging in various types of tumors, including both primary and metastatic cancer lesions. This prospective, single-center study aims to provide important insights into how different tumors take up this imaging tracer, helping to identify the most promising uses of 68Ga-NYM096 PETCT for future cancer diagnosis and treatment assessment. Participants will receive a single intravenous dose of 68Ga-NYM096, with the amount adjusted based on body weight. After injection, a whole-body PETCT scan will be performed approximately 45 to 75 minutes later to capture detailed images of tumor uptake. The study focuses on quantitative analysis of tracer uptake in cancer lesions, measuring factors such as lesion number, maximum standardized uptake value SUVmax, and tumor-to-background ratio. During the study, participants will undergo the PETCT imaging procedure and provide informed consent. Researchers will analyze the images to assess tracer uptake characteristics in confirmed tumors. Safety and compliance with study procedures will be monitored. The main outcome is the quantitative assessment of tumor lesions on the 68Ga-NYM096 PETCT scan, evaluated from study completion to one month after. The study plans to enroll 120 patients with confirmed cancer diagnoses and will follow ethical guidelines throughout the research.

Researchers are studying the stimulator of interferon gene STING protein, which plays an important role in the immune systems ability to detect tumors. This trial focuses on evaluating a new imaging agent called 68GaGa-Sa-DABI-4, designed to noninvasively detect STING expression in the tumor environment using positron emission tomography PET. The study aims to assess the safety, distribution in the body, and potential usefulness of this imaging agent for cancer patients. Participants will receive one intravenous injection of the investigational drug 68GaGa-Sa-DABI-4 during the study. This single administration is followed by PET imaging to monitor how the agent interacts with the tumor. The study is conducted in an early phase 1 design, focusing on initial safety and diagnostic capabilities. During the trial, participants will undergo PET scans to evaluate the diagnostic effectiveness of the imaging agent within 15 days after injection. Researchers will monitor safety and how the drug distributes throughout the body. The study includes patients suspected of having or newly diagnosed with malignant diseases. Participation involves a single dosing and imaging session, with safety and diagnostic data collected during this period.