This phase Ib/II trial evaluates the safety, optimal dose, and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or responded to previous treatment (refractory). Epcoritamab, a bispecific antibody, binds to two different types of receptors (proteins present on the cell surface) at the same time. The two receptors that epcoritamab binds to are called CD3 and CD20. CD3 is found on T cells, which are important cells of the immune system that help fight cancer and infections. CD20 is found on the surface of most types of aggressive B-cell non-Hodgkin lymphoma cells. By binding to both CD3 and CD20, epcoritamab brings the two cells close together so the T cells can fight and kill the lymphoma B cells. Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, binds to a protein on B cells, a type of white blood cell from which the lymphoma developed. By doing this it decreases the ability of the lymphoma B cells to survive and grow. Ibrutinib may also improve the health (or fitness) of T cells thus making epcoritamab safer and/or more effective.

开始日期2024-10-31

申办/合作机构

Ohio State University Comprehensive Cancer Center

[+2]

NCT05077527 / Recruiting临床1期IIT

Axicabtagene Ciloleucel in Relapsed or Refractory HIV-Associated Aggressive B-Cell Non-Hodgkin Lymphoma

This phase I trial evaluates the side effects and usefulness of axicabtagene clioleucel (a CAR-T therapy) and find out what effect, if any, it has on treating patients with HIV-associated aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or not responded to treatment (refractory). T cells are infection fighting blood cells that can kill tumor cells. Axicabtagene ciloleucel consists of genetically modified T cells, modified to recognize CD-19, a protein on the surface of cancer cells. These CD-19-specific T cells may help the body's immune system identify and kill CD-19-positive B-cell non-Hodgkin lymphoma cells.

开始日期2024-05-03

申办/合作机构

Memorial Sloan Kettering Cancer Center

[+1]

NCT05886036 / Recruiting临床2期IIT

NORM: Nodular Lymphocyte-Predominant Hodgkin Lymphoma Patients Treated in a Randomized Phase 2 Trial With Either Rituximab or Mosunetuzumab

This phase II trial compares mosunetuzumab to the usual treatment (rituximab) for improving survival in patients with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). Rituximab and mosunetuzumab are monoclonal antibodies. They bind to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab may be more effective at extending survival in patients with NLPHL than the usual approach with rituximab.

开始日期2024-01-23

申办/合作机构

National Cancer Institute

100 项与复发性 3b 级滤泡性淋巴瘤相关的临床结果

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100 项与复发性 3b 级滤泡性淋巴瘤相关的转化医学

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0 项与复发性 3b 级滤泡性淋巴瘤相关的专利（医药）

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项与复发性 3b 级滤泡性淋巴瘤相关的文献（医药）

2024-05-01·DMW - Deutsche Medizinische Wochenschrift

Neue Klassifikationen maligner Lymphome – Welche Änderungen sind für die Praxis relevant?

Review

作者: Rudelius, Martina ; Hartmann, Sylvia

An internationally uniform lymphoma classification is of fundamental importance for the comparability of clinical studies. There are currently 2 parallel classifications: the "International Consensus Classification" and the WHO-classification. Follicular lymphoma 3B is classified separately as follicular large cell lymphoma in WHO-HAEM5. The diagnostic criteria of lymphoplasmocytic lymphoma (LPL) have been adjusted, both classifications recommend molecular testing for MYD88 and CXCR4 mutations. There are no significant diagnostic changes in aggressive B-cell lymphomas. The ICC classify NLPBL and THRLBCL into the group of large B-cell lymphomas (LBCL). NLPHL/NLPBL-specific therapy must be considered, which differs greatly from the therapy of DLBCL, especially in the early stages. Peripheral T-cell lymphomas are a group of nodal T-cell lymphomas with a TFH phenotype and frequent mutations; peripheral T-cell lymphoma (NOS) is therefore a diagnosis of exclusion. Indolent T-cell lymphomas/lymphoproliferations of the GI tract are rare but must be differentiated from aggressive T-cell lymphomas. The WHO-HAEM5 also includes reactive/non-neoplastic lymph node lesions classified according to B or T cell predominance.

2024-01-01·Folia Pharmacologica Japonica

悪性リンパ腫治療薬エプコリタマブ（遺伝子組換え）（エプキンリ<sup>®</sup>皮下注）の薬理学的特性と臨床試験成績

Article

作者: Ganoza, Edward Ramirez ; Takaura, Kana ; Ando, Hiroshi

The prognosis of patients with B-cell non-Hodgkin lymphoma (B-NHL) has improved with the use of anti-CD20 based immunochemotherapy. However, management of relapsed or refractory disease remains a challenge, indicating a high unmet need for novel treatments. Epcoritamab (recombinant) is a humanized immunoglobulin G1 (IgG1) bispecific antibody that simultaneously binds to CD3 on T cells and CD20 on B cells or tumor cells inducing T-cell mediated cytotoxicity against CD20-positive B cells. It demonstrated consistent cytotoxic effects in B-cell lymphoma cell line-derived xenograft models, patient-derived xenograft models, and cynomolgus monkey studies. Pharmacological studies in cynomolgus monkeys showed peak plasma concentrations of cytokines were lower with subcutaneous versus intravenous administration. To reduce the risk of cytokine release syndrome (CRS) and improve convenience, Epcoritamab has been developed as a subcutaneous formulation.To further reduce the risk of CRS, clinical trials utilized a priming dose and incremental dose increases. In Phase I/II overseas trials with relapsed, progressive, or refractory B-NHL patients, the recommended Phase II trial dose was determined based on safety, efficacy, and pharmacokinetic model simulation results. The Phase II dose-expansion part demonstrated the efficacy and high tolerability of epcoritamab monotherapy at the recommended dose. Similar efficacy and tolerability were observed in Japanese Phase I/II trials in relapsed or refractory B-NHL patients. Based on these results, epcoritamab received the approval in September 2023 for the treatment of "relapsed or refractory large B-cell lymphoma (DLBCL, HGBCL, PMBCL)" and "relapsed or refractory follicular lymphoma (Grade 3B)" in Japan.

2023-10-01·Oncology letters

BR vs. R‑miniCHOP in unfit patients with B‑cell non‑Hodgkin lymphoma: A randomized, two‑center, cohort study.

Article

作者: Lin, Yong ; Zhang, Liling ; Zhang, Dongdong ; Dong, Youhong

The aim of the present study was to compare the efficacy and safety between the bendamustine plus rituximab (BR) regimen and rituximab combined with low-dose doxorubicin, cyclophosphamide, vincristine and prednisone (R-miniCHOP) in the treatment of 'unfit' patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma grade 3B (FL3B). Patients, >70 years of age with DLBCL or FL3B, defined as unfit according to Comprehensive Geriatric Assessment, were included in the present study. All patients received 4-6 cycles of a BR or R-miniCHOP regimen at a three-week interval. The objective remission rate (ORR) and adverse reactions were evaluated between the two groups. A total of 35 patients, recruited between January 2020 and December 2021, were included in this prospective study. The median age was 74 years (range, 70-82 years). The ORR in the BR group was similar to that in the R-miniCHOP group (73.3 vs. 75.0%; P=0.606). However, the BR group exhibited a lower incidence of leukopenia than the R-miniCHOP group (20.0 vs. 60.0%; P=0.037). The univariate analysis revealed that the ORR was influenced by the serum β₂ microglobulin level. The BR regimen showed equivalent efficacy but more improved safety compared with R-miniCHOP in unfit patients with DLBCL and FL3B. The BR regimen may be considered as an alternative treatment in these subgroups of patients.