Feasibility and Safety of Collecting and Combining Autologous Hematopoietic Stem Cells With Chimeric...
Hematologic MalignancyLarge B-cell Lymphoma4 moreThe study is designed to examine the feasibility and safety of collecting autologous hematopoietic stem cells (HSCs) to be combined with CAR T-cell therapy for patients with relapsed/refractory (r/r) hematological disease. The study will evaluate feasibility of collecting the target dose of HSCs from at least 50% of enrolled patients. The study will assess safety based on incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in the first 60 days post CAR T dosing, and also through the collection of adverse events (AEs) and serious adverse events (SAEs) as well as the durability of response after treatment with HSCs with CAR T. The study follows an open-label, single-center and single non-randomized cohort design. 20 subjects with r/r hematological malignancies will be enrolled and treated to evaluate the feasibility and preliminary safety of collecting autologous HSCs and combining them with CAR T-cell therapy.
A Multicenter, Phase 2 Study Evaluating the Value of Radiotherapy in Advanced Diffuse Large B-cell...
Advanced Diffuse Large B-Cell LymphomaExtra-nodal Involvement2 moreThis study is a prospective, single center, phase II clinical study involving 108 patients with primary and late stage Diffuse Large B-cell Lymphoma complicated by large masses and extranodal involvement. The study aims to evaluate the efficacy of radiotherapy targeting large masses and extranodal involvement in treatment-naïve advanced DLBCL patients with large mass lesions and/or extranodal involvement after they had initially been treated with standard immunochemotherapy and received complete remission as assessed by PET-CT. After completing the standard immunochemotherapy, subjects will be randomly divided into the radiotherapy group or the non-radiotherapy group, and the curative effects will be evaluated every three months after the end of the treatment or after their leaving the group, so as to obtain the relevant data and data of the 2-year Progression Free Survival, survival of the subjects and Treatment-related side effects.
Mitoxantrone Hydrochloride Liposome Injection in Patients With Relapsed/Refractory Diffuse Large...
Diffuse Large B-Cell LymphomaA multicenter, single-arm, phase 2 study of mitoxantrone hydrochloride liposome injection in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients...
Large B-cell LymphomaTo learn if adding epcoritamab to the treatment combination R-miniCVP (rituximab, cyclophosphamide, vincristine, prednisone) can help to control newly diagnosed DLBCL. The safety of this combination will also be studied.
Relmacabtagene Autoleucel as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL
LymphomaLarge B-Cell4 moreThe primary objective of this study is to asess the efficacy of Relmacabtagene autoleucel as second-line therapy in adult patients with aggressive B-cell Non-Hodgkins Lymphoma who are ineligible for haematopoietic stem cell transplantation.
Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell...
Central Nervous System LymphomaDiffuse Large B-Cell LymphomaThis study evaluates pharmacogenomic effects on high-dose methotrexate clearance in patients with diffuse large B-cell lymphoma.
Study of Orelabrutinib in Combination With Gemox in Refractory / Relapsed Diffuse Large B-cell Lymphoma...
DLBCLThis study aims to investigate the treatment of refractory or relapsed DLBCL with orelabrutinib and gemox. The primary endpoint is response rate (complete response rate and overall response rate), and the second endpoints are survival time (OS and PFS) and toxicities.
Safety, Efficacy and Pharmacokinetics of XKDCT023 in DLBCL
Diffuse Large B Cell LymphomaThis study is a phase I multicenter, single arm, open, dose increasing, single treatment clinical study. This study plans to recruit a total of about 10-16 adult patients with CD19 positive recurrent or refractory DLBCL for a single autologous car-t cell therapy. There are three dose groups in the study. The first dose group has one patient. If there is no dose limiting toxicity (DLT), it can be increased to the second dose group, otherwise it will continue to be enrolled according to the "3 + 3" method; The follow-up dose group is conducted according to the traditional "3 + 3" design, that is, three subjects are first enrolled in a dose group. If there is no dose limiting toxicity (DLT) in the three patients in the dose group, it can be increased to the next higher dose after completing the DLT observation period; If DLT occurs in 1 of the 3 patients in the dose group, it is necessary to continue to enroll 3 patients in the dose group for DLT observation. The highest dose level of DLT in less than or equal to 1 of the last 6 confirmed patients will be defined as MTD. The safety of car-t treatment was evaluated by observing the adverse events after cell therapy; Evaluate the effectiveness of car-t treatment compared with the results or historical data of the patient's own previous standard treatment regimen. Blood and bone marrow were collected before and 12 months after cell infusion, the number and activity of car-t cells were detected, and the pharmacokinetics (PK) of car-t cells was evaluated.
High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host...
Acute LeukemiaChronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma14 moreThis pilot phase II trial studies how well high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil work in preventing graft versus host disease in patients with hematological malignancies undergoing myeloablative or reduced intensity donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). Giving high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil after the transplant may stop this from happening.
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies...
Accelerated Phase Chronic Myelogenous LeukemiaAdult Acute Lymphoblastic Leukemia in Remission125 moreThis randomized phase I trial studies the side effects of vaccine therapy in preventing cytomegalovirus (CMV) infection in patients with hematological malignancies undergoing donor stem cell transplant. Vaccines made from a tetanus-CMV peptide or antigen may help the body build an effective immune response and prevent or delay the recurrence of CMV infection in patients undergoing donor stem cell transplant for hematological malignancies.