CD19 CAR-T Expressing IL7 and CCL19 Combined With PD1 mAb for Relapsed or Refractory Diffuse Large...
Diffuse Large B-cell LymphomaDiffuse large B-cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma, accounting for 35% of lymphoma. Chimeric antigen receptor T cell (CAR-T) therapy is a new method to treat DLBCL. KTE-C19, published in the New England Medical Journal in December 2017, was used to treat relapsed and refractory B-cell lymphoma. One year of treatment for 111 patients, the total response rate was 82%, and the complete remission rate was 54%. However, a large number of clinical studies have shown that about 20% of patients with B-ALL and 50% of patients with B-NHL cannot achieve complete remission (CR) after CD19-CAR-T treatment. Targeting tumor microenvironment is an important new method to overcome the drug resistance of CAR-T cells. In this study, IL-7 and CCL19 were connected on the basis of traditional second generation CD19 CAR-T cells to construct novel fourth generation CAR-T cells, which can promote the infiltration, accumulation and survival of CAR-T cells in lymphoma tissue, and further enhance the anti-tumor effect of traditional CAR-T cells. At the same time, combined with four generations of CAR-T cells and PD1 monoclonal antibody, PD1 / PDL1 signal pathway was blocked, anti-tumor effect of CAR-T was improved, and immune response and long-term remission rate of DLBCL were improved.
Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T
Relapsed/Refractory B-cell LymphomasDiffuse Large B-Cell Lymphoma (DLBCL)10 moreThis study is designed as a long-term follow-up study of participants who have receive genetically modified autologous CLBR001 CAR-T cells
Abbreviated 3 Cycles of Rituximab Plus CHOP(Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone)...
Diffuse Large B-cell LymphomaPhase 2 Study of Abbreviated 3 Cycles of Rituximab plus CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy in Patients with Completely Excised Localized Gastrointestinal CD20 (+) Diffuse Large B-cell Lymphoma(SATURDAY STUDY)
A Phase II Trial of Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy for...
Diffuse Large B Cell LymphomaA phase II trial of ifosfamide, etoposide, cytarabine, and methotrexate (IVAM) chemotherapy for refractory or relapsed diffuse large B cell lymphoma
Exosomes and Immunotherapy in Non-Hodgkin B-cell Lymphomas
LymphomaB-cell1 moreDiffuse large B-cell lymphomas (DLBCL) are highly aggressive and heterogeneous B-cell lymphoma that would imminently be fatal without treatment. Monoclonal anti-CD20 antibody, rituximab, in combination of CHOP chemotherapy (R-CHOP) is widely used with favourable results. Although more than half of patients achieve long-term remission, many are not cured with this immunotherapy. Suboptimal response and/or resistance to rituximab have remained a challenge in the therapy of DLBCL but also of all B-NHL. Exosomes are microvesicles released from tumor B cells that are found in plasma of patients with B-NHL. Exosomes carry therapeutic targets (as CD20, PDL-1) and could act as "decoy-receptors" for immunotherapy. Our objective is to precise, in aggressive B-NHL, the role of exosomes in immunotherapy escape.
Evaluating the Feasibility of a Digital Health Coaching Program for Individuals Following CAR T...
LymphomaLymphoma7 moreThe aim of this study is to evaluate the feasibility of a digital health coaching program for, and to describe quality of life of, individuals in the 6 months following chimeric antigen receptor (CAR) T cell therapy. Up to 50 English-speaking individuals aged 18 and older who are to receive treatment with a CAR T cell therapy will be enrolled, all at The University of Texas MD Anderson Cancer Center. Participants must have internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments and will be excluded if they are unable to provide informed consent or have a prognosis of 6 months or less. Consented participants will be enrolled in a 6-month digital health coaching program delivered via weekly calls from a Health Advisor coupled with the digital delivery of content. The program focuses on identification and escalation of treatment-related toxicity, communication with providers, and physical and psychosocial health following treatment. Health related quality of life (HRQoL) will be assessed with the Functional Assessment of Cancer Therapy-Lymphoma (FACT-L), health self-efficacy will be assessed by the Cancer Behavior Inventory-Brief (CBI-B), physical and mental health outcomes will be measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health 10. Patient experience in managing CAR T specific care will be assessed with a 5-item questionnaire developed specifically for use in this study, focused on participants' confidence in understanding, identifying and managing symptoms, and communicating with providers. Study outcomes will contribute to knowledge about if and how a digital health intervention may be used to support individuals post-CAR T cell therapy.
Study of Purinostat Mesylate for Injection in the Treatment of Diffuse Large B-cell Lymphoma (DLBCL)...
Diffuse Large B Cell Lymphoma,DLBCLPurinostat mesylate for injection (PM) was the novel and highly potent Class I a and IIb HDAC-selective inhibitors. The results of regular blood sampling analysis of the mouse B-cell lymphoma model induced by ighmyc transgenic mice showed that the treatment of PM in each group reduced the proportion of peripheral blood tumor cells in mice. Therefore, PM has the potential to treat diffuse large B cell lymphoma. The results of in vitro enzymatic activity screening showed that PM has high inhibitory activity on HDAC tumors (including HDAC1, 2, 3, 8 subtypes) and type II HDACs (including HDAC6, 10 isoforms), which are closely related to tumors in the HDAC family. Therefore, the results of in vitro enzyme activity screening showed that the IC50 values of PM for inhibiting HDAC1, HDAC2, HDAC3, HDAC8, HDAC6, and HDAC10 subtypes of HDAC class I and HDAC class IIb were 0.81, 1.4, 1.7, 3.8, 11.5, and 11 nM, respectively. However, the inhibitory activity of HDAC IIa and HDAC IV enzymes was low, and its IC50 values for HDAC4, HDAC5, HDAC7, HDAC9, and HDAC11 subtypes of HDAC IIa and HDAC IV were 1072, 426, 590, 622, and 3349 nM, respectively. These data means PM exist high selectivity for tumor-associated HDAC class I and HDAC IIb. Compared with the blank control group, the body weight of the tumor-bearing animals in each dose of PM group did not decrease seriously during the treatment process, and the animals were in good condition during the whole experiment, indicating that the PM is efficacy and safe. Main purpose: To further explore the safe and effective dose of priinostat mesylate for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma. To evaluate the objective response rate (ORR) of priinostat mesylate for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma. Secondary purpose: To explore the biomarkers related to the efficacy of priinostat mesylate for injection. To evaluate the time to tumor response (TTR), duration of response (DOR), disease control rate (DCR), and progression-free survival (PFS) in the treatment of relapsed or refractory diffuse large B-cell lymphoma with prilinostat mesylate for injection ), overall survival (OS). Assessing the safety and tolerability of priinostat mesylate for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma.
Single-Cell Map of Immune and Lymphoma Cells in B-cell Non-Hodgkin's Lymphoma
Diffuse Large B-cell LymphomaThis trial is a translational, prospective, open-label, monocentric research. The study will be conducted in a population of 60 patients with diffuse large B-cell lymphoma (DLBCL) for whom first-line treatment with R-CHOP is planned as part of their standard of care. SIMILY program aims at identifying biomarkers and/or molecular signatures related to immuno-phenotypic and -genotypic characteristics of the tumor and immune microenvironment, at the time of diagnosis, during R-CHOP, and at 24 months or time of progression. Each patient will be followed during 2 years.
Geriatric Assessment Guided Interventions to Accelerate Functional Recovery After CAR-T Therapy...
B-Cell Non-Hodgkin LymphomaMultiple MyelomaThis clinical trial compares the effectiveness of geriatric assessment (GA) guided interventions to accelerate functional recovery after chimeric antigen receptor T-cell (CAR-T) therapy compared to standard of care (SOC) in patients 60 years and older with B-cell non-Hodgkin lymphoma (NHL) or multiple myeloma (MM). A large number of patients diagnosed with cancer are over the age of 60, yet most cancer treatments are developed for younger patients. Therefore, older patients may be less likely to be offered stronger treatments, such as CAR-T therapy, due to possible side effects. Geriatric assessment is a multi-dimensional health assessment tool combining patient reported and objective measures covering physical function, mental processes (cognitive), and nutrition. Pre-treatment assessments may identify weaknesses in older adults and may guide interventions for physical therapy, cognitive changes and nutrition to decrease CAR-T therapy side effects and improve care in older adults with NHL or MM.
A Mixed Methods Study of Nutrition Practice in Cancer Care on Non-Hodgkin Lymphoma Population
LymphomaB-CellThe effects of calorie or sugar control on health and disease has been a hot topic. While established evidence has proven the health benefits of long-term calorie restriction, recent preclinical studies show encouraging results of the beneficial effects of short-term fasting on cancer treatment. In particular, short-term calorie control seems to be safe and has the potential to increase cancer cell's sensitivity to chemotherapy whereas protect normal cells from chemotherapy-induced toxicity. More human trials are needed before translating this intervention into clinical practice. The overall goal of this study is to examine if nutrition status and an intervention of sugar and calorie modification will affect patient outcomes in patients with diffuse large B-Cell lymphoma (DLBCL) receiving chemo therapy which includes Rituximab, Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone(R-CHOP). This 5-year research project with three phases will be conducted at National Taiwan University Hospital. The first phase is a case control, observational study. By reviewing electronic charts of patients who (1) were newly diagnosed with DLBCL within the past 5 years, (2) received R-CHOP, (3) were 20-year-old or older at diagnosis, we seek to examine specific aim 1 and 2. About 500 cases are needed in this phase to achieve 80% power. The second phase is a pilot study requiring 50 participants to assess feasibility of the protocol. The third phase is a prospective cohort study in which the safety, feasibility, and effects of a calorie modification protocol are examined (aim 3, 4, and 5), participants will be randomized to experimental and comparison group. While comparison group will receive standard care, experimental group will follow the protocol of calorie modification.