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Obinutuzumab [RO5072759 (GA101)] 联合 CHOP 化疗治疗先前未治疗的晚期弥漫性大 B 细胞淋巴瘤 (GATHER) 患者的研究

2026年9月24日 更新者：Genentech, Inc.

GA101 (RO5072759) 与 CHOP 化疗联合治疗先前未治疗的晚期弥漫性大 B 细胞淋巴瘤患者的疗效、安全性和生物标志物的 II 期、开放标签、多中心研究

This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab [RO5072759 (GA101)] in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients will receive 8 cycles of obinutuzumab (1000 mg intravenously on Day 1 of each 21-day cycle, during Cycle 1 obinutuzumab will also be infused on Days 8 and 15) in combination with CHOP chemotherapy on Day 1 of cycles 1 to 6. A substudy will investigate the drug-drug interaction of obinutuzumab with CHOP chemotherapy agents. For the substudy, an additional cohort of approximately 15 patients are planned to be enrolled at a subset of investigational sites.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

100

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。

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294-3300
        • University of Alabama at Birmingham
    • California
      • Encinitas、California、美国、92024
        • cCare
    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado Cancer Center Department of Hematology
      • Denver、Colorado、美国、80218
        • Rocky Mountain Cancer Ctr - Denver (Williams)
    • Connecticut
      • Norwalk、Connecticut、美国、06856
        • Norwalk Hospital
    • Florida
      • Fort Myers、Florida、美国、33901-8101
        • Florida Cancer Specialists; Department of Oncology
      • St. Petersburg、Florida、美国、33719
        • Florida Cancer Specialists; Saint Petersburg
    • Georgia
      • Marietta、Georgia、美国、30060
        • Northwest Georgia Oncology Centers PC - Marietta
    • Idaho
      • Coeur d'Alene、Idaho、美国、83814
        • Kootenai Medical Center
    • Illinois
      • Chicago、Illinois、美国、60611
        • Northwestern University; Robert H. Lurie Comp Can Ctr
      • Peoria、Illinois、美国、61615-7828
        • Onc Hem Assoc of Central IL
    • Iowa
      • Ames、Iowa、美国、50010
        • McFarland Clinic
    • Kentucky
      • Louisville、Kentucky、美国、40245
        • Jewish Cancer Care
    • Massachusetts
      • Worcester、Massachusetts、美国、01655
        • University of Massachusetts Medical School
    • Michigan
      • Ann Arbor、Michigan、美国、48109-0934
        • University of Michigan
    • Montana
      • Missoula、Montana、美国、59802
        • MT Cancer Inst Fndtn; MT Can Spec
    • Nevada
      • Las Vegas、Nevada、美国、89128
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Basking Ridge、New Jersey、美国、07920
        • MSKCC at Basking Ridge
      • Hackensack、New Jersey、美国、07601
        • Hackensack University Medical Center
    • New Mexico
      • Farmington、New Mexico、美国、87401
        • San Juan Oncology Associates
    • New York
      • Commack、New York、美国、11725
        • Memorial Sloan-Kettering; Cancer Center
      • New York、New York、美国、10065
        • Memorial Sloan Kettering Cancer Center
      • Rockville Centre、New York、美国、11570
        • MSKCC at Mercy Med Ctr
      • Sleepy Hollow、New York、美国、10591
        • MSKCC at Sleepy Hollow
    • North Carolina
      • High Point、North Carolina、美国、27262
        • Emerywood Hematology and Onc
    • Oregon
      • Springfield、Oregon、美国、97477
        • Willamette Valley Cancer Insitute and Research Center
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Medical University of SC (MUSC)
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • SCRI-Tennessee Oncology
    • Texas
      • Fort Worth、Texas、美国、76177
        • Onc & Hem Assoc; USO Cent Pharm
      • Houston、Texas、美国、77030
        • Methodist Hospital Research Institute
      • Houston、Texas、美国、77030
        • MD Anderson Cancer Center Department of Lymphoma & Myeloma
      • San Antonio、Texas、美国、78229
        • Cancer Therapy & Research Center
      • Tyler、Texas、美国、75702
        • USO - Tyler Cancer Ctr
    • Virginia
      • Roanoke、Virginia、美国、24014
        • Blue Ridge Cancer Care - Roanoke
    • Washington
      • Spokane、Washington、美国、99208
        • Medical Oncology Associates
      • Vancouver、Washington、美国、98684
        • Northwest Cancer Specialists - Vancouver
      • Yakima、Washington、美国、98902
        • Yakima Valley Memorial Hospital/North Star Lodge
    • Wisconsin
      • Green Bay、Wisconsin、美国、54311
        • Aurora Bay Care 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:

  • Adult patients, ≥18 years of age
  • Previously untreated cluster of differentiation antigen 20 (CD20)-positive diffuse large B-cell lymphoma
  • Ann Arbour Stage III/IV and bulky II (mass >10 cm)
  • At least one bi-dimensionally measurable lesion defined as >1.5 cm in its largest dimension by CT scan
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Left ventricular ejection fraction ≥50%
  • Adequate hematologic function

Exclusion Criteria:

  • Transformed lymphoma (follicular IIIB) if previously treated with chemotherapy or immunotherapy
  • Prior therapy for diffuse large B-cell lymphoma except for nodal biopsy or local irradiation
  • Central nervous system (CNS) lymphoma, primary mediastinal large cell lymphoma, primary cutaneous lymphoma, primary effusion lymphoma
  • Patients who received cytotoxic drugs or rituximab as part of their treatment for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody
  • Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1
  • Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
  • History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix, or malignancy treated with or without curative intent and in remission without treatment for ≥2 years prior to enrolment
  • Positive for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or human T-cell leukemia virus (HTLV-1) infection
  • Pregnant or lactating women

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：不适用
  • 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：obinutuzumab + CHOP

Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy (cyclophosphamide, doxorubicin, vincristine and prednisone) for 6 cycles.
药品：obinutuzumab

1000 mg intravenously on Day 1 of each 21-day cycle, 8 cycles; during Cycle 1 administration also on Days 8 and 15.

药品：cyclophosphamide

750 mg/m^2 intravenous (IV), Day 1 of each 21-day cycle, 6 cycles.

药品：doxorubicin

50 mg/m^2 IV, Day 1 of each 21-cycle, 6 cycles.

药品：prednisone

100 mg/day, Days 1 through 5 of each 21-day cycle, 6 cycles.

药品：vincristine

1.4 mg/m^2 IV, Day 1 of each 21-day cycle, 6 cycles.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment
大体时间：From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)

Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT). CR is the disappearance of all evidence of disease.
From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Overall Response Rate (ORR) as Assessed by the Investigator at the End of Treatment
大体时间：From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)

Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, FDG-PET and computed tomography (CT). CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.
From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)

次要结果测量

结果测量
措施说明
大体时间
Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment
大体时间：From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)

Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease.
From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Overall Response Rate (ORR) as Assessed by the IRF at the End of Treatment
大体时间：From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)

Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.
From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Progression-Free Survival (PFS) as Assessed by the Investigator
大体时间：From the first dose of study treatment to PFS assessment (up to 64 months)

PFS was defined as the time from the date of the first dose of study treatment until the date of disease progression, relapse, or death from any cause.
From the first dose of study treatment to PFS assessment (up to 64 months)
Duration of Response (DOR)
大体时间：From the response assessment to relapse, progression, or death (up to 64 months)

DOR is defined as first occurrence of documented response (CR or PR) until the first occurrence of relapse or progression or death of any cause. CR: disappearance of all evidence of disease. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.
From the response assessment to relapse, progression, or death (up to 64 months)
Percentage of Participants With Adverse Events as a Measure of Safety
大体时间：From the first dose of study treatment to end of study (up to 5 years 4 months)

An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug or other protocol-imposed intervention. Preexisting conditions that worsened during the study were reported as adverse events.
From the first dose of study treatment to end of study (up to 5 years 4 months)
Number of Participants With Grade 3 to 4 Infusion-Related (IRR) Adverse Events (AE) in Participants Receiving Shorter Duration Infusion (SDI)
大体时间：From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)

SDI 120 is a shorter duration infusion of 120 minutes and SDI 90 is shorter duration infusion of 90 minutes. Grade 3 IRR AE: Prolonged (e.g., not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4 IRR AE: Life-threatening consequences; urgent intervention indicated.
From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for Obinutuzumab
大体时间：Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12

Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).
Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab
大体时间：Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12

T1/2 is the time required for the concentration of the drug to reach half of its original value. Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in days
Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
Pharmacokinetics: Clearance (Cl) for Obinutuzumab
大体时间：Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12

Cl is the volume of serum cleared of the drug per unit of time. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters/day (mL/day).
Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab
大体时间：Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12

V is the apparent volume in which a drug is distributed in the body. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters (mL).
Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day)
大体时间：Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12

Blood was collected for PK parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in in day times micrograms per milliliter (day*μg/mL).
Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Depletion
大体时间：From end of study treatment up to approximately 30 months

B-cell depletion was defined as a CD19 result < 0.07 × 10^9/L after at least one dose of study drug had been administered. Participants were evaluated during a 30-month post-treatment follow-up period following the completion of active study treatment (Cycle 8 [each cycle = 21 days]). Total study duration across active treatment and follow-up was up to approximately 5 years.
From end of study treatment up to approximately 30 months
Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Recovery
大体时间：Up to approximately 30 months

B-cell recovery was defined as a CD19 result >= 0.07 × 10^9/L, where CD19 was previously depleted. B-cell recovery was only considered possible following the last dose of study treatment. The number of participants with B-cell recovery from End of Treatment to 6 months of Follow-up is reported in two categories: Recovery with Progressive Disease (PD) [PD before B-cell recovery or PD within 45 days after recovery] or Recovery without PD. PD required one of the following: 50% increase in the absolute number of circulating lymphocytes, Appearance of new palpable lymph nodes, 50% increase in the longest diameter of any previous site of lymphadenopathy, 50% increase in the enlargement of the liver and/or spleen or Transformation to a more aggressive histology.
Up to approximately 30 months

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

Genentech, Inc.

调查人员

  • 研究主任：Clinical Trials、Genentech, Inc.

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。

一般刊物

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)

2011年8月31日

初级完成 (实际的)

2013年12月31日

研究完成 (实际的)

2016年12月23日

研究注册日期

首次提交

2011年8月10日

首先提交符合 QC 标准的

2011年8月10日

首次发布 (估计的)

2011年8月11日

研究记录更新

最后更新发布 (实际的)

2026年9月29日

上次提交的符合 QC 标准的更新

2026年9月24日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • GAO4915g

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