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未治療の進行性びまん性大細胞型B細胞リンパ腫患者を対象としたCHOP化学療法と併用したオビヌツズマブ[RO5072759 (GA101)]の研究(GATHER)

2026年9月24日 更新者:Genentech, Inc.

CHOP化学療法とGA101(RO5072759)を併用して治療を受けた未治療の進行性びまん性大細胞型B細胞リンパ腫患者における有効性、安全性、バイオマーカーに関する第II相非盲検多施設共同研究

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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

100

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

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

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

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

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

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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment
時間枠: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
時間枠: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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Clinical Trials、Genentech, Inc.

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2011年8月31日

一次修了 (実際)

2013年12月31日

研究の完了 (実際)

2016年12月23日

試験登録日

最初に提出

2011年8月10日

QC基準を満たした最初の提出物

2011年8月10日

最初の投稿 (推定)

2011年8月11日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月29日

QC基準を満たした最後の更新が送信されました

2026年9月24日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • GAO4915g

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。