이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

이전에 치료받지 않은 진행성 미만성 거대 B세포 림프종(GATHER) 환자에서 CHOP 화학요법과 병용한 Obinutuzumab[RO5072759(GA101)] 연구

2026년 9월 24일 업데이트: Genentech, Inc.

CHOP 화학요법과 병용하여 GA101(RO5072759)로 치료받은 이전에 치료받지 않은 진행성 미만성 거대 B세포 림프종 환자의 효능, 안전성 및 바이오마커에 대한 II상, 공개 라벨, 다기관 연구

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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

100

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: obinutuzumab

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

의약품: cyclophosphamide

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

의약품: doxorubicin

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

의약품: prednisone

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

의약품: vincristine

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment
기간: 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
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Genentech, Inc.

수사관

  • 연구 책임자: Clinical Trials, Genentech, Inc.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2011년 8월 31일

기본 완료 (실제)

2013년 12월 31일

연구 완료 (실제)

2016년 12월 23일

연구 등록 날짜

최초 제출

2011년 8월 10일

QC 기준을 충족하는 최초 제출

2011년 8월 10일

처음 게시됨 (추정된)

2011년 8월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 24일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GAO4915g

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다