R-DHAP vs POLA-R-DHAP Followed by Autologous Transplant as First Salvage Treatment in Patient With...
Diffuse Large B Cell Lymphoma RefractoryDiffuse Large B-cell Lymphoma RecurrentProspective, multicenter, open label, phase II randomized clinical trial in DLBCL patients relapsed or refractory to first line R-chemo, aged 18-70 years and candidate to autologous transplant. Patients will be randomized 1:1 to received 4 cycles of R-DHAP or R-DHAP plus Polatuzumab Vedotin as induction treatment plus autologous transplant.
A Phase I Trial to Establish the Safety and Maximum Tolerated Dose of High-affinity Autologous BCMA-targeting...
NeoplasmsRelapsed Diffuse Large B-cell Lymphoma (DLBCL)4 moreThe purpose of this phase I study is to determine whether MDC-CAR-BCMA001 (BCMA directed CAR T-cells) is safe and tolerable in the treatment of relapsed and refractory B-cell malignancies
Sintilimab Plus R-GemOx as Second-line Salvage Therapy in Patients With R/R DLBCL
Diffuse Large B Cell LymphomaRelapsed Diffuse Large B-Cell Lymphoma1 moreThis study evaluates the addition of Sintilimab to current 2nd line salvage therapy of Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) for patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL). All patients will receive four cycles of sintilimab plus R-GemOx. Afterwards, 1) patients who achieve CR assessed by PET-CT and are eligible for autologous stem cell transplantation (ASCT) will undergo ASCT. After transplantation, patients will receive sintilimab monotherapy up to 8 cycles or until disease recurrence and progression, death, intolerance and toxicity, withdrawal of informed consent, or other reasons specified in the protocol. 2) Patients who achieve CR assessed by PET-CT and are not eligible for ASCT will directly receive sintilimab monotherapy as maintenance treatment for a maximum of 8 cycles as described above. 3) Patients achieved PR, SD or PD assessed by PET/CT will withdraw from this study and receive proper treatment based on investigator's decision.
A Phase I/II Study of Diffuse Large B-cell Lymphoma
Refractory Diffuse Large B-cell LymphomaFor continuous variables, mean, median, minimum, and maximum will be used for the descriptive purpose. For categorical variables, frequency and percentage will be used for descriptive statistics. The variables of OS will be estimated by the Kaplan-Meier method. Differences between groups will be calculated using the log-rank test for univariate analysis. Cox's proportional hazards model will be employed to test independent prognostic factors. All calculations will be performed using the Statistical Package of Social Sciences software, version 17.0 (SPSS, Inc., Chicago, IL, USA). The level of statistical significance will be set at 0.05 for all tests.
CD30biAb-AATC for CD30+ Malignancies
Pediatric CancerHodgkin Disease11 moreThis first-in-human trial will assess the safety, feasibility, and efficacy of an immunotherapy with a novel CD30 antibody conjugated to a CD3 antibody that is preloaded onto a patient's own T-cells, generating a CD30 bispecific antibody-armed, anti-CD3-activated, autologous T-cells (CD30 biAb-AATC).
Safety and Efficacy of CT125A Cells for Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies...
CD5+ Relapsed/Refractory Hematopoietic MalignanciesChronic Lymphocytic Leukemia (CLL)4 moreCurrent treatments for relapsed/refractory hematopoietic malignancies such as B-cell lymphomas (BCLs) and peripheral T-cell lymphomas (PTCLs) are far from satisfactory. CD5 is widely expressed in multiple subtypes of BCLs and PTCLs but rarely found in normal tissues except certain types of lymphocytes. Chimeric antigen receptor (CAR) T cells against CD5 offer another potential therapeutic option for patients with relapsed/refractory CD5 positive hematopoietic malignancies. In the current study, the safety and efficacy of a novel CAR T cell therapy, termed CT125A cells, are evaluated in patients with relapsed/refractory CD5+ hematopoietic malignancies. The endogenous CD5 in CT125A cells is knocked out via CRISPR/Cas9 genome editing technology to prevent fratricide during CAR T cells manufacturing.
The Potential of Patient-reported Outcome Measures in Detection of Relapse in Diffuse Large B-cell...
Diffuse Large B Cell LymphomaPatient Reported OutcomeAnnually some 450 patients are diagnosed with Diffuse Large B-cell Lymphoma (DLBCL), in Denmark. The majority of these patients are cured with immunochemotherapy, but up to 30 % will relapse, pointing to the need for targeted surveillance and follow-up strategy. However, this strategy is constantly under debate illustrated by the missing data supporting scheduled face-to-face meetings with a clinician and routine surveillance scans in order to detect relapse. On top of the clinical problems comes the psychological burden for patients enrolled in routine surveillance. This points to the need for the development of evidence-based follow-up programs both in terms of content, regularity and assignment of responsibility between the health system and the patient. In a prospective cohort study, the investigators will collect Patient Reported Outcome (PRO) measures investigating if questionnaires can be used to detect relapse in DLBCL patients. Furthermore psychological aspects of follow-up are explored.
First-line Treatment of P53 Mutation With PD-L1 Expression in DLBCL With Anti-PD-1 Mab and R-CHOP...
Diffuse Large B-Cell LymphomaDiffuse large B-cell lymphoma (DLBCL) is the most common type of lymphoma。The majority of refractory patients have PD-L1 expression due to P53 mutations, some of which account for about 10% of DLBCL.Our department has found that in refractory DLBCL with high PD-L1 expression, cedilizumab monotherapy is also more effective and has reversed chemotherapy resistance.The aim of this study was to determine whether the addition of sindilizumab to the R-CHOP regimen could improve the objective efficiency of DLBCL patients with P53 mutation with PD-L1 expression and to see if it could prolong patient survival.
P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies
Diffuse Large B Cell LymphomaFollicular Lymphoma4 morePhase 1 study comprised of open-label, dose escalation and expansion cohort study of P-CD19CD20-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed/refractory B cell malignancies
Optimizing Lymphodepletion to Improve Outcomes in Patients Receiving Cell Therapy With Kymriah
LymphomaLarge B-Cell1 moreThis is a Phase 1b study of participants with Diffuse Large B Cell Lymphoma (DLBCL). The purpose of this study is to identify an optimized lymphodepletion (LD) regimen by evaluating standard and intermediate doses of Fludarabine (Flu) / Cyclophosphamide (Cy) with or without a fixed dose of total lymphoid irradiation (TLI) in the setting of standard of care chimeric antigen receptor T (CAR T) cell therapy.