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 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.

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 11 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 therapys 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 relapsedrefractory 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 children and adults with blood cancers and other related disorders. This observational study involves patients with hematologic malignancies and various inherited and acquired disorders affecting the blood and immune system. The main goal is to monitor how well neutrophil recovery occurs after transplantation using these unlicensed CBUs in multiple institutions. Participants receive unlicensed cryopreserved CBUs as part of their transplant treatment. The study includes patients of any age receiving these CBUs for approved indications. The protocol focuses on the access and distribution of these unlicensed units rather than a specific treatment intervention. The study gathers data from recipients who receive these CBUs, tracking outcomes after transplantation. Participants are monitored for neutrophil recovery at 60 and 100 days after transplant, defined by a neutrophil count of at least 500mm3. Researchers also collect information on infection transmission, infusion reactions, survival rates at one year, and incidence of acute and chronic graft versus host disease. Platelet recovery is also evaluated. Safety and efficacy outcomes are followed over time to better understand the effects of unlicensed CBUs in this patient population.

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 12 study aims to determine the optimal biological dose and assess the therapys 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 killerT-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.

Researchers are evaluating whether telehealth music therapy can be a practical treatment for cognitive difficulties in adults who have survived blood cancers such as lymphoma, leukemia, or myeloma. The study also examines if music therapy and music education can help improve cognitive function as well as symptoms like anxiety, depression, and fatigue in this population. This pilot trial is exploring these effects in hematologic cancer survivors who experience cancer-related cognitive dysfunction. Participants will be assigned to one of three groups the experimental music therapy MT group, the therapist-attention music education TAME control group, or a wait-list control WLC group receiving usual care. Those in the MT and TAME groups will receive 12 weekly 60-minute sessions, with homework assignments between sessions to reinforce skills and concepts. The WLC group completes assessments during a 24-week wait period and can later choose to receive either the MT or TAME intervention. During the study, participants will complete assessments to measure the feasibility of telehealth music therapy, defined by completing at least 9 of the 12 sessions. Researchers will monitor cognitive function, mood symptoms, and fatigue. Participants must be able to complete study assessments independently and consent in English. The total study duration includes the intervention period and follow-up assessments to evaluate outcomes related to cancer-related cognitive dysfunction.