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一项研究，用于评估Glofitamab细胞因子释放综合征的优化与吉西他滨和奥沙利铂联合使用的参与者中的复发/难治性弥漫性大B细胞淋巴瘤的研究。

2026年11月6日 更新者：Hoffmann-La Roche

一项II期开放标签的多中心研究，用于评估Glofitamab的细胞因子释放综合征概况与吉西他滨加上吉西他滨加Oxaliptin在复发/难治性弥漫性大型B细胞淋巴瘤的患者中的优化。

This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) followed by glofitamab monotherapy treatment regimen (Cohort A), and for glofitamab monotherapy (Cohort B) in participants with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma. The study utilizes an optimized steroid premedication regimen and monitoring schedule specifically designed to enable the administration of the treatment regimen in an outpatient setting.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

130

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

研究联系人备份

  • 姓名：Reference Study ID Number: GO45434 https://forpatients.roche.com/ No attachments to email below.
  • 电话号码：888-662-6728 (U.S. Only)
  • 邮箱：global-roche-genentech-trials@gene.com

学习地点

  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 5G2
        • 招聘中
        • Arthur J.E. Child Comprehensive Cancer Center
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3E 0V9
        • 招聘中
        • CancerCare Manitoba (CCMB)
  • 德国
      • Berlin、德国、12200
        • 撤销
        • CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
      • Berlin、德国、13353
        • 撤销
        • Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
      • Cologne、德国、50937
        • 招聘中
        • Universitätsklinikum Köln
      • Magdeburg、德国、39120
        • 招聘中
        • Otto von Guericke Uni Magdeburg Uniklinik
  • 意大利
    • Campania
      • Naples、Campania、意大利、80131
        • 招聘中
        • Istituto Nazionale Tumori Irccs Fondazione g. Pascale
    • Emilia-Romagna
      • Meldola、Emilia-Romagna、意大利、47014
        • 招聘中
        • IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
    • Lombardy
      • Brescia、Lombardy、意大利、25123
        • 招聘中
        • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
      • Milan、Lombardy、意大利、20141
        • 招聘中
        • Irccs Istituto Europeo Di Oncologia (IEO)
      • Rozzano、Lombardy、意大利、20089
        • 招聘中
        • Istituto Clinico Humanitas
  • 法国
      • La Tronche、法国、38700
        • 招聘中
        • CHU de Grenoble
      • Montpellier、法国、34295
        • 招聘中
        • Chu de Montpellier-St Eloi
      • Pessac、法国、33600
        • 招聘中
        • CHU de Bordeaux
      • Rennes、法国、35033
        • 撤销
        • CHU DE RENNES - CHU Pontchaillou
      • Tours、法国、37000
        • 招聘中
        • Chu De Tours
  • 澳大利亚
    • Victoria
      • East Melbourne、Victoria、澳大利亚、3002
        • 招聘中
        • Epworth Hospital
  • 美国
    • Alaska
      • Anchorage、Alaska、美国、99508
        • 招聘中
        • Alaska Oncology & Hematology, LLC
    • California
      • Clovis、California、美国、93611
        • 招聘中
        • Community Cancer Institute (CCI)
      • Fullerton、California、美国、92835
        • 招聘中
        • Providence Medical Foundation
      • Glendale、California、美国、91204
        • 撤销
        • Los Angeles Cancer Network
      • Los Angeles、California、美国、90067
        • 招聘中
        • Valkyrie Clinical Trials
      • Panorama City、California、美国、91402
        • 招聘中
        • Valkyrie Clinical Trials
      • San Francisco、California、美国、94110
        • 招聘中
        • Zuckerberg San Francisco General Hospital
      • Torrance、California、美国、90502-2006
        • 招聘中
        • The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
    • Colorado
      • Aurora、Colorado、美国、80012
        • 招聘中
        • Rocky Mountain Cancer Centers, LLP
    • Florida
      • Gainesville、Florida、美国、32608
        • 撤销
        • North Florida/ South Georgia VA Medical Center
      • Miami、Florida、美国、33140
        • 招聘中
        • Mount Sinai Comprehensive Cancer Center
      • Orlando、Florida、美国、32806
        • 招聘中
        • Orlando Health Cancer Institute
    • Idaho
      • Boise、Idaho、美国、83712
        • 招聘中
        • St Luke?s Cancer Institute
    • Illinois
      • Swansea、Illinois、美国、62226
        • 招聘中
        • Cancer Care Specialists of Central Illinois
    • Iowa
      • Waukee、Iowa、美国、50263
        • 招聘中
        • Mission Blood and Cancer - MercyOne Cancer Center
    • Kentucky
      • Lexington、Kentucky、美国、40536
        • 招聘中
        • University of Kentucky - Markey Cancer Center
    • Louisiana
      • Baton Rouge、Louisiana、美国、70809
        • 招聘中
        • Mary Bird Perkins Cancer Ctr
    • Massachusetts
      • Boston、Massachusetts、美国、02118
        • 招聘中
        • Boston Medical Center
    • Michigan
      • Grand Rapids、Michigan、美国、49503
        • 招聘中
        • Corewell Health
    • Nebraska
      • Omaha、Nebraska、美国、68130
        • 招聘中
        • Nebraska Cancer Specialists
    • New York
      • Albany、New York、美国、12206
        • 招聘中
        • New York Oncology Hematology, P.C.
      • East Syracuse、New York、美国、13057
        • 招聘中
        • Hematology Oncology Associates of Central New York
    • Oregon
      • Eugene、Oregon、美国、97401
        • 招聘中
        • Oncology Associates of Oregon, P.C
      • Portland、Oregon、美国、97213
        • 招聘中
        • Providence Portland Medical Center
      • Portland、Oregon、美国、97225
        • 招聘中
        • Providence St. Vincent Medical Center
    • Tennessee
      • Chattanooga、Tennessee、美国、37403
        • 招聘中
        • Tennessee Oncology
      • Nashville、Tennessee、美国、37203
        • 招聘中
        • Tennessee Oncology
    • Texas
      • Temple、Texas、美国、76502
        • 招聘中
        • Baylor Scott & White Health
      • The Woodlands、Texas、美国、77380
        • 招聘中
        • Texas Oncology - Gulf Coast
      • Tyler、Texas、美国、75702
        • 招聘中
        • Texas Oncology- Northeast Texas
    • Virginia
      • Fairfax、Virginia、美国、22031
        • 招聘中
        • Virginia Cancer Specialists, PC
      • Virginia Beach、Virginia、美国、23456
        • 招聘中
        • Virginia Oncology Associates - Virginia Beach
    • Washington
      • Tacoma、Washington、美国、98405
        • 招聘中
        • Northwest Medical Specialties
  • 韩国
      • Seongnam-si、韩国、463-707
        • 主动，不招人
        • Seoul National University Bundang Hospital
      • Seoul、韩国、03080
        • 撤销
        • Seoul National University Hospital
      • Seoul、韩国、05505
        • 主动，不招人
        • Asan Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Life expectancy >= 12 weeks.

  • For participants in the Glofit-GemOx combination therapy cohort (Cohort A) and the glofitamab monotherapy cohort (Cohort B), participant with histologically confirmed diffuse large B-cell lymphoma, (de novo or transformed from a follicular lymphoma (FL); participants with transformed FL must be relapsed or refractory (R/R) to standard therapies of transformed FL) with one of the following diagnoses according to World Health Organization, fifth edition (Alaggio et al. 2022). A fresh biopsy at study entry is not mandated. The histology can be confirmed based on fresh biopsy, or pathology report from a previous biopsy or an assessment of archival tumor tissue.

    1. Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified (NOS).
    2. High-Grade B-Cell Lymphoma (HGBL), NOS.
    3. DLBCL/HGBL with myelocytomatosis proto-oncogene (MYC) and B-cell lymphoma 2 (BCL2) rearrangements.

  • R/R disease, defined as: relapsed = disease that has recurred following a response that lasted >/= 6 months after completion of the last line of therapy; refractory = disease that did not respond to or that progressed < 6 months after completion of the last line of therapy.

  • At least one line of prior systemic therapy.

  • Participants who have failed one prior line of therapy (eligible to Cohort A) must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant.

  • At least one bi-dimensionally measurable (> 1.5 cm) nodal lesion, or one bi-dimensionally measurable (> 1 cm) extranodal lesion, as measured on CT scan.

  • Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2.

  • According to the investigator's judgment, participants should be able to receive the step-up dose regimen in an outpatient setting.

Exclusion Criteria:

  • Prior enrollment in Studies GO41943 (NCT04313608), GO41944 (STARGLO; NCT04408638), or Study GO44900 (NCT06624085).
  • Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation.
  • Any history of Waldenstrom's macroglobulinemia.
  • Primary mediastinal B-cell lymphoma.
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products.
  • Contraindication to obinutuzumab, gemcitabine or oxaliplatin, or tocilizumab. For participants in the monotherapy cohort (Cohort B), participants with contraindication to obinutuzumab or tocilizumab will be excluded.
  • Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3.
  • For the Glofit-GemOx combination therapy cohort (Cohort A), prior treatment with gemcitabine or oxaliplatin.
  • For the Glofit-GemOx combination therapy cohort (Cohort A), peripheral neuropathy or paresthesia assessed to be Grade >= 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrolment.
  • Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment.
  • Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment.
  • Primary or secondary CNS lymphoma at the time of recruitment.
  • Prior CNS involvement that has been definitively treated and confirmed via magnetic resonance imaging (MRI) or cerebrospinal fluid analysis to be in complete remission is permissible.
  • Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
  • History of other primary malignancy, with exceptions defined by the protocol.
  • Significant or extensive cardiovascular disease.
  • Significant pulmonary disease (including moderate or severe obstructive pulmonary disease).
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to the first study treatment.
  • Positive for: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); tuberculosis; hepatitis B virus (HBV); hepatitis C virus (HCV); chronic active Epstein-Barr viral infection.
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) or progressive multifocal leukoencephalopathy.
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better (with the exception of alopecia and anorexia).
  • Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study.
  • Prior solid organ transplantation or prior allogenic stem cell transplant.
  • Active autoimmune disease requiring treatment.
  • Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents), within 4 weeks prior to first dose of study treatment.
  • Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the participant at increased risk of steroid-related iatrogenic adrenal insufficiency.
  • Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis.
  • Clinically significant history of cirrhotic liver disease.
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high-risk from treatment complications.
  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 18 months after the final dose of study treatment.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Cohort A: Glofit-GemOx Combination therapy

Participants with R/R aggressive B-cell Non-Hodgkin's Lymphoma will receive obinutuzumab pre-treatment, followed by glofitamab + gemcitabine + oxaliplatin, followed by glofitamab monotherapy.

NOTE: Cohort A has been closed for recruitment.
药品：Obinutuzumab

Participants will receive intravenous (IV) obinutuzumab 7 days prior to the first dose of glofitamab.

其他名称：
  • RO5072759
药品：Glofitamab

Participants will receive IV glofitamab, both in combination with gemcitabine and oxaliplatin and as monotherapy, for up to 12 cycles (cycle length = 21 days).

其他名称：
  • RO7082859
药品：Gemcitabine

Participants will receive IV gemcitabine in combination with glofitamab and oxaliplatin for up to 8 cycles (cycles length = 21 days).

药品：Oxaliplatin

Participants will receive IV oxaliplatin in combination with glofitamab and gemcitabine for up to 8 cycles (cycle length = 21 days).
实验性的：Cohort B: Glofitamab Monotherapy

Participants with R/R aggressive B-cell Non-Hodgkin's Lymphoma will receive obinutuzumab pre-treatment, followed by glofitamab monotherapy.
药品：Obinutuzumab

Participants will receive intravenous (IV) obinutuzumab 7 days prior to the first dose of glofitamab.

其他名称：
  • RO5072759
药品：Glofitamab

Participants will receive IV glofitamab, both in combination with gemcitabine and oxaliplatin and as monotherapy, for up to 12 cycles (cycle length = 21 days).

其他名称：
  • RO7082859

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Incidence of Cytokine Release Syndrome (CRS)
大体时间：Up to approximately 5 years
Up to approximately 5 years

次要结果测量

结果测量
措施说明
大体时间
Incidence of Serious Cytokine Release Syndrome (CRS) Events
大体时间：Up to approximately 5 years
Up to approximately 5 years
CRS Frequency Relative to the Start of Glofitamab Infusions
大体时间：Up to approximately 5 years
Up to approximately 5 years
Incidence and Severity of Adverse Events (AEs)
大体时间：Up to approximately 5 years
Up to approximately 5 years
Complete Response (CR) Rate as Determined by Independent Review Facility (IRF) and the Investigator
大体时间：Up to approximately 5 years

CR rate is defined as the proportion of participants whose best overall response is a CR based on PET/CT according to the 2014 Lugano Response Criteria during the study, as determined by the Independent Review Facility and the investigator.
Up to approximately 5 years
Overall Response Rate (ORR) as Determined by IRF and the Investigator
大体时间：Up to approximately 5 years

ORR is defined as the proportion of participants whose best overall response is a PR or a CR according to the 2014 Lugano Response Criteria during the study, as determined by the Independent Review Facility and the investigator.
Up to approximately 5 years
Duration of Response (DOR)
大体时间：From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)

DOR is defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression, or death from any cause, whichever occurs first.
From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)
Duration of Complete Response (DOCR)
大体时间：From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)

DOCR is defined as the time from the first occurrence of a documented CR to disease progression, or death from any cause, whichever occurs first.
From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)
Progression-Free Survival (PFS) as Determined by the IRF and the Investigator
大体时间：From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)

PFS is defined as the time from enrollment to the first occurrence of disease progression according to the 2014 Lugano Response Criteria or death from any cause, whichever occurs first, as determined by the Independent Review Facility and investigator.
From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)
Overall Survival (OS)
大体时间：From enrollment to date of death from any cause (Up to approximately 5 years)

OS is defined as the time from enrollment to date of death from any cause.
From enrollment to date of death from any cause (Up to approximately 5 years)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hoffmann-La Roche

调查人员

  • 研究主任：Study Director、Hoffmann-La Roche

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年3月5日

初级完成 (估计的)

2029年7月31日

研究完成 (估计的)

2030年7月31日

研究注册日期

首次提交

2025年1月21日

首先提交符合 QC 标准的

2025年1月30日

首次发布 (实际的)

2025年2月3日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月6日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • GO45434
  • 2024-516791-15-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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