T-Cell Lymphoma

This research aims to evaluate the effectiveness and safety of a combination treatment using Selinexor, Pegaspargase, and Dexamethasone for patients with early-stage NK/T-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.

Researchers are studying the use of 3'-deoxy-3'-[18F] fluorothymidine (FLT) positron emission tomography (PET) imaging in patients with cancer. This phase I trial aims to evaluate how well FLT PET imaging measures tumor growth and the activity of the DNA synthetic pathway in various cancers, including solid tumors and blood cancers. The study also seeks to determine how effective this imaging method is at detecting lesions and assessing response to treatment. Participants receive up to four FLT PET imaging procedures. During each procedure, a small amount of the FLT tracer compound is injected into the vein, followed by PET scan data collection for two hours to measure tumor growth. Blood samples may be taken during the scans, and urine samples collected afterward to analyze breakdown products of the tracer. Throughout the study, patients undergo assessments including PET or CT PET scans to measure tracer uptake and retention in tumors and normal organs. Researchers also evaluate changes in key enzymes related to DNA synthesis before and after therapy. These evaluations help monitor tumor activity and treatment response. The total time participants spend in the scanner during imaging is up to two hours per session, with a focus on capturing detailed tumor growth information.

Researchers are studying the safety, how the body processes, and effectiveness of a drug called CHT101 in adults aged 18 to 70 who have certain types of relapsed or refractory blood cancers, including Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma, and Non-Hodgkin Lymphoma. This research is a Phase 1, open-label, single-arm study aiming to find the best dose and observe initial effects in these patients. The treatment involves giving CHT101, a CD70-targeted UCAR-T cell therapy, to participants. The study starts with a dose escalation phase where three dose levels will be tested. After a safety review committee evaluates safety, drug levels in the body, and early responses, a dose expansion phase will begin to further assess the treatment. Participants will be closely monitored for side effects, treatment responses, and how the drug moves and acts in the body over two years. Researchers will measure dose-limiting toxicity and maximum tolerated dose within 28 days of the first infusion. Other outcomes include adverse events, response rates, progression-free survival, overall survival, pharmacokinetics, and pharmacodynamics. Safety and effectiveness will be followed for up to two years after treatment begins.

Researchers are evaluating SCTC21C, a biological treatment, in patients with relapsed or refractory CD38-positive hematologic malignancies. This multicenter, open-label Phase I trial aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary anti-tumor activity, and immune response to SCTC21C. The study includes a dose-finding stage to determine safe dosage levels and a dose-expansion stage to further evaluate selected doses. In the dose-finding stage, participants receive increasing doses of SCTC21C ranging from 0.01 mg up to 960 mg. In the dose-expansion stage, at least 20 participants are randomly assigned in a 1:1 ratio to receive two different doses determined from the earlier stage. SCTC21C is given by subcutaneous injection weekly for the first two cycles, then every two weeks for cycles three to six, and every four weeks thereafter until disease progression or unacceptable side effects occur. Participants will be closely monitored throughout the study with assessments including safety evaluations, adverse event tracking up to 45 days after the last dose, and measuring dose-limiting toxicities during the first 28-day cycle. Researchers will also evaluate tumor response over about one year of treatment. The study expects participants to have regular visits for treatment and monitoring, with the total duration varying depending on individual response and tolerability.

Researchers are evaluating the safety and effectiveness of combining Cidabenamine with Azacitidine as maintenance therapy after allogeneic peripheral blood hematopoietic stem cell transplantation in patients with high-risk peripheral T-cell lymphoma. This phase II clinical trial aims to prevent disease progression in this group of patients. The study is conducted at a single center and plans to enroll 40 patients, focusing on those meeting specific high-risk criteria and transplant conditions. Participants will receive the combination of Cidabenamine and Azacitidine following their transplant. Before treatment, patients will undergo screening including consent, eligibility verification, and collection of demographic and medical history data. Assessments such as vital signs, physical exams, PET-CT scans, bone marrow tests, flow cytometry, lymphoid gene rearrangement analysis, and bone marrow pathology will be performed to monitor health and disease status. Throughout the study, researchers will track overall survival up to 2 years as the primary outcome. Secondary outcomes include progression-free survival, non-relapse mortality, and relapse rates within 1 to 2 years. Patients will be closely monitored for treatment responses and safety. The total participation duration spans from screening through follow-up assessments, allowing comprehensive evaluation of the maintenance therapy's impact.

This observational study focuses on patients aged 18 and older who have lymphoproliferative disorders, a group of blood cancers affecting the lymphatic system. Researchers aim to understand the overall survival over 10 years for different types of these disorders. The study also examines factors like patient fitness, comorbid conditions, and how these influence treatment choices and outcomes. New therapies including chemo-free protocols, targeted drugs, and cell therapies are being evaluated to determine the best treatment sequences for cases that are refractory or relapsed. Participants will be observed through various phases of their disease, including diagnosis and treatment stages. The study investigates the impact of clinical and biological factors on disease progression or relapse, as well as potential links between genetic profiles and clinical outcomes. It also monitors adverse events like tumor lysis syndrome and their effects on treatment adjustments. Additionally, the study looks at patients managed with a watch-and-wait approach, long-term toxicities, secondary cancers, and healthcare resource use. Throughout the study, participants' health and treatment outcomes will be regularly assessed using clinical data collected from diagnosis through follow-up. Researchers will analyze survival rates, treatment effectiveness, and side effects over a long period from 2002 to 2030. This comprehensive data collection aims to improve understanding of lymphoproliferative disorders and optimize patient management strategies over time.

Researchers are conducting a global observational study to understand mature T-cell and NK-cell neoplasms (TNKL), which are types of lymphomas. The study aims to link molecular changes in the tumors to patient outcomes like overall survival and treatment response. It also explores how machine learning can help identify genetic factors that influence how patients respond or resist treatments, moving toward more personalized care. This study enrolls patients who are newly diagnosed or have relapsed/refractory TNKL from multiple institutions worldwide. Participants will be followed for up to four years during their clinical management. Researchers will collect data on demographics, clinical features, pathology, molecular tumor details, imaging, treatments, and quality of life. Genetic testing including whole exome and RNA sequencing will be done on tumor samples and other biological materials to provide a comprehensive molecular profile. Participants will have routine clinical visits where data and samples will be collected by research teams. The study will monitor key outcomes like overall survival, progression-free survival, response duration, and adverse events over four years. Data will be securely shared among sites, and advanced deep learning models will analyze the molecular information alongside clinical outcomes to predict patient responses and survival across different lymphoma subtypes and treatments.

Researchers are studying the use of unlicensed cryopreserved cord blood units (CBUs) for transplantation in both pediatric and adult patients with various blood-related cancers and other disorders affecting the blood-forming system. This observational study aims to evaluate outcomes such as the recovery of a certain level of white blood cells after transplantation, as well as the incidence of infections, infusion reactions, survival rates, and graft-versus-host disease over time. The study involves patients receiving unlicensed CBUs at multiple U.S. transplant centers. These CBUs are used for patients with hematologic malignancies and other blood disorders. The protocol collects data on patients who receive these unlicensed transplant units, without administering a new treatment but observing the outcomes after transplantation. Participants will be monitored for neutrophil recovery at 60 and 100 days post-transplant, along with assessments of infection transmission, infusion reactions, survival one year after transplant, and occurrences of acute and chronic graft-versus-host disease. Platelet engraftment levels will also be tracked. The study includes patients of any age and follows them through the transplantation and recovery process to gather information on these key outcomes.

Researchers are evaluating the safety and effectiveness of anti-CD5 CAR-T cell therapy in patients with relapsed or refractory CD5-positive T-cell malignancies who have limited treatment options. This multi-center, open-label, non-randomized phase 1/2 study aims to determine the optimal biological dose and assess the therapy's impact on cancer in these patients. The study includes three groups based on the source of the CAR T cells: autologous, previous stem-cell transplant donor-derived, or newly matched donor-derived cells. Participants will receive a lymphodepleting treatment followed by an infusion of CD5 CAR T cells from one of the three sources. The study will explore different doses, starting from 1 million cells per kilogram to 2 million cells per kilogram, with a lower dose option if cell production is insufficient. The trial involves a dose-finding phase (phase 1) to evaluate safety and a phase 2 to assess treatment response. Participants will be monitored closely for side effects and treatment response, with assessments including adverse event tracking up to two years and evaluation of tumor response at 3 months after infusion. Additional outcome measures include pharmacokinetics, progression-free survival, and overall survival. The total study duration includes monitoring for safety and effectiveness for up to two years after treatment infusion.

Researchers are evaluating the safety and effectiveness of sequential chemoradiotherapy with or without the addition of toripalimab, a PD-1 antibody, in people newly diagnosed with early-stage extranodal natural killer/T-cell lymphoma, nasal type (ENKTL). This phase 3, randomized, multi-center clinical trial aims to compare these two treatment approaches to better understand their impact on this specific lymphoma type. Participants are assigned to one of two groups. One group receives toripalimab combined with induction chemotherapy using pegaspargase, gemcitabine, and oxaliplatin every three weeks for four cycles prior to radiation. They then receive intensity-modulated radiotherapy (IMRT) and continue toripalimab every three weeks during and after radiation for a total of 13 cycles. The other group receives the same chemotherapy and radiation schedule without toripalimab. Throughout the study, participants undergo regular evaluations to monitor treatment response and safety. Researchers will measure progression-free survival over three years as the primary outcome. Secondary outcomes include complete remission rate, overall response rate, overall survival, recurrence-free survival, event-free survival, and disease-free survival, all tracked up to three years or six months as appropriate. The study follows participants from the start of treatment through multiple years to assess long-term outcomes.