A Study of Obinutuzumab in Combination With Chemotherapy in Participants With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma (GAUDI)
2016년 11월 3일 업데이트: Hoffmann-La Roche
An Open-Label, Multi-Centre, Randomised, Phase Ib Study to Investigate the Safety and Efficacy of RO5072759 Given in Combination With CHOP, FC or Bendamustine Chemotherapy in Patients With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma
This open-label, randomized, phase Ib study will assess the safety and efficacy of obinutuzumab given in combination with FC (fludarabine and cyclophosphamide) or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) or bendamustine induction chemotherapy in participants with Cluster of Differentiation (CD) 20+ B-cell Follicular Lymphoma (FL).
Participants with complete response or partial response after induction therapy may receive maintenance therapy every 3 months for 2 years or until disease progression, whichever comes first.
All participants in the induction period of the study will have a safety follow-up visit 28 days after completing the last dose of obinutuzumab + chemotherapy, and will be followed for at least 2 years, unless they are being treated in maintenance or discontinue from the study prior to this time point.
Participants who complete/discontinue maintenance therapy will also be followed for a period of 2 years after receiving the last dose of obinutuzumab or until progression/new antilymphoma treatment.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
137
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Aschaffenburg, 독일, 63739
-
Freiburg, 독일, 79106
-
Göttingen, 독일, 37075
-
Heidelberg, 독일, 69120
-
Kiel, 독일, 24105
-
Köln, 독일, 50924
-
Muenchen, 독일, 81377
-
Ulm, 독일, 89081
-
Würzburg, 독일, 97080
-
-
-
-
-
Barcelona, 스페인, 08036
-
Barcelona, 스페인, 08003
-
Barcelona, 스페인, 08035
-
Salamanca, 스페인, 37007
-
Valencia, 스페인, 46026
-
-
-
-
-
Leicester, 영국, LE1 5WW
-
London, 영국, SE5 9RS
-
Manchester, 영국, M20 4QL
-
Plymouth, 영국, PL6 8DH
-
Southampton, 영국, SO16 6YD
-
Truro, 영국, TR1 3LJ
-
-
-
-
Lazio
-
Roma, Lazio, 이탈리아, 00161
-
-
Lombardia
-
Milano, Lombardia, 이탈리아, 20132
-
-
Piemonte
-
Torino, Piemonte, 이탈리아, 10126
-
-
-
-
-
Lille, 프랑스, 59037
-
Montpellier, 프랑스, 34295
-
Pierre Benite, 프랑스, 69495
-
-
-
-
New South Wales
-
Kogarah, New South Wales, 호주, 2217
-
Sydney, New South Wales, 호주, 2145
-
-
Queensland
-
Greenslopes, Queensland, 호주, 4120
-
Woolloongabba, Queensland, 호주, 4102
-
-
South Australia
-
Kurralta Park, South Australia, 호주, 5037
-
-
Victoria
-
Frankston, Victoria, 호주, 3199
-
Melbourne, Victoria, 호주, 3000
-
Melbourne, Victoria, 호주, 3084
-
-
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:
- Either CD20+ R/R B-cell follicular non-Hodgkin's lymphoma (after a maximum of 2 prior chemotherapy regimens) or CD20+ B-cell follicular non-Hodgkin's lymphoma with no prior systemic therapy
- Must have at least one bi-dimensionally measurable lesion (greater than [>] 1.5 centimeters [cm] in its largest dimension by computed tomography [CT] scan)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Exclusion Criteria:
- For R/R participants recruited in Obinutuzumab + CHOP regimen, prior use of anthracyclines. For R/R participants recruited in Obinutuzumab + FC regimen, immediate prior treatment should not have contained fludarabine or fluoropyrimidines. For first-line recruited participants, prior systemic therapy
- Prior administration of rituximab within 56 days of study entry, or 3 months for any radioimmunotherapy
- Central nervous system lymphoma
- History of other malignancies within 2 years of study entry which could affect compliance with the protocol or interpretation of results
- Known active bacterial, viral (including human immunodeficiency virus [HIV]), fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of dosing
- Contraindication to any of the individual components of chemotherapy (as per local prescribing information), of the selected chemotherapy combination (FC, CHOP or bendamustine)
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: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: A: R/R FL: Obinutuzumab Low Dose + CHOP
Participants with Relapsed/Refractory (R/R) FL will receive obinutuzumab 400 milligrams (mg) intravenous (IV) infusion on Days 1 and 8 of Cycle 1 and every 3 weeks on Day 1 of subsequent cycles (for 68 cycles) in the induction period; Prednisone 100 mg/day orally on Days 15, doxorubicin 50 milligrams per square-meter (mg/m^2), vincristine 1.4 mg/m^2 capped at 2 mg, and cyclophosphamide 750 mg/m^2 IV infusion every 3 weeks on Day 1 of each cycle for 68 cycles in the induction period.
12 weeks following last infusion, participants with CR or PR will be eligible to receive 400 mg obinutuzumab IV infusion once every 3 months for 2 years or until disease progression in the maintenance period.
|
Obinutuzumab은 해당 부문에 지정된 일정에 따라 투여됩니다.
다른 이름들:
프레드니손은 각 팔에 지정된 일정에 따라 투여됩니다.
Cyclophosphamide will be administered as per schedule specified in the respective arm.
Doxorubicin will be administered as per schedule specified in the respective arm.
Vincristine will be administered as per schedule specified in the respective arm.
|
|
실험적: B: R/R FL: Obinutuzumab High Dose + CHOP
Participants with R/R FL will receive obinutuzumab 1600 mg IV infusion on Days 1 and 8 of Cycle 1 and 800 mg IV infusion every 3 weeks on Day 1 of subsequent cycles (for 68 cycles) in the induction period; Prednisone 100 mg/day orally on Days 15, doxorubicin 50 mg/m^2, vincristine 1.4 mg/m^2 capped at 2 mg, and cyclophosphamide 750 mg/m^2 IV infusion every 3 weeks on Day 1 of each cycle for 68 cycles in the induction period.
12 weeks following last infusion, participants with CR or PR will be eligible to receive 800 mg obinutuzumab IV infusion once every 3 months for 2 years or until disease progression in the maintenance period.
|
Obinutuzumab은 해당 부문에 지정된 일정에 따라 투여됩니다.
다른 이름들:
프레드니손은 각 팔에 지정된 일정에 따라 투여됩니다.
Cyclophosphamide will be administered as per schedule specified in the respective arm.
Doxorubicin will be administered as per schedule specified in the respective arm.
Vincristine will be administered as per schedule specified in the respective arm.
|
|
실험적: C: R/R FL: Obinutuzumab Low Dose + FC
Participants with R/R FL will receive obinutuzumab 400 mg IV infusion on Days 1 and 8 of Cycle 1 and every 4 weeks on Day 1 of subsequent cycles (for 46 cycles) in the induction period; Fludarabine 25 mg/m^2/day and cyclophosphamide 250 mg/m^2/day IV infusion every 4 weeks on Days 13 of each cycle for 46 cycles in the induction period.
12 weeks following last infusion, participants with CR or PR will be eligible to receive 400 mg obinutuzumab IV infusion once every 3 months for 2 years or until disease progression in the maintenance period.
|
Obinutuzumab은 해당 부문에 지정된 일정에 따라 투여됩니다.
다른 이름들:
Cyclophosphamide will be administered as per schedule specified in the respective arm.
Fludarabine will be administered as per schedule specified in the respective arm.
|
|
실험적: D: R/R FL: Obinutuzumab High Dose + FC
Participants with R/R FL will receive obinutuzumab 1600 mg IV infusion on Days 1 and 8 of Cycle 1 and 800 mg IV infusion every 4 weeks on Days 1 of subsequent cycles (for 46 cycles) in the induction period; Fludarabine 25 mg/m^2/day and cyclophosphamide 250 mg/m^2/day IV infusion every 4 weeks on Days 13 of each cycle for 46 cycles in the induction period.
12 weeks following last infusion, participants with CR or PR will be eligible to receive 800 mg obinutuzumab IV infusion once every 3 months for 2 years or until disease progression in the maintenance period.
|
Obinutuzumab은 해당 부문에 지정된 일정에 따라 투여됩니다.
다른 이름들:
Cyclophosphamide will be administered as per schedule specified in the respective arm.
Fludarabine will be administered as per schedule specified in the respective arm.
|
|
실험적: E: First-Line FL: Obinutuzumab + Bendamustine
Participants with first-line FL will receive obinutuzumab 1000 mg IV infusion on Days 1 and 8 of Cycle 1 and every 4 weeks on Day 1 of subsequent cycles (for 46 cycles) in the induction period; Bendamustine 90 mg/m^2 IV infusion on Days 2 and 3 of Cycle 1 and every 4 weeks on Days 1 and 2 of each subsequent cycle for 46 cycles in the induction period.
12 weeks following last infusion, participants with CR or PR will be eligible to receive 1000 mg obinutuzumab IV infusion once every 3 months for 2 years or until disease progression in the maintenance period.
|
Obinutuzumab은 해당 부문에 지정된 일정에 따라 투여됩니다.
다른 이름들:
Bendamustine will be administered as per schedule specified in the respective arm.
|
|
실험적: F: First-Line FL: Obinutuzumab + CHOP
Participants with first-line FL will receive obinutuzumab 1000 mg IV infusion on Days 1 and 8 of Cycle 1 and every 3 weeks on Day 1 of subsequent cycles (for 68 cycles) in the induction period; Prednisone 100 mg/day orally on Days 15, doxorubicin 50 mg/m^2, vincristine 1.4 mg/m^2 capped at 2 mg, cyclophosphamide 750 mg/m^2 IV infusion every 3 weeks on Day 1 of each cycle for 68 cycles in the induction period.
12 weeks following last infusion, participants with CR or PR will be eligible to receive 1000 mg obinutuzumab IV infusion once every 3 months for 2 years or until disease progression in the maintenance period.
|
Obinutuzumab은 해당 부문에 지정된 일정에 따라 투여됩니다.
다른 이름들:
프레드니손은 각 팔에 지정된 일정에 따라 투여됩니다.
Cyclophosphamide will be administered as per schedule specified in the respective arm.
Doxorubicin will be administered as per schedule specified in the respective arm.
Vincristine will be administered as per schedule specified in the respective arm.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Percentage of Participants With Adverse Events (AEs) - Relapsed/Refractory Population
기간: Baseline up to maximum observation time of 79.5 months
|
Baseline up to maximum observation time of 79.5 months
|
|
Percentage of Participants With AEs - First-line Population
기간: Baseline up to maximum observation time of 59.7 months
|
Baseline up to maximum observation time of 59.7 months
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Percentage of Participants With End of Induction Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
기간: 28 days after end of induction treatment (up to 28 weeks)
|
28 days after end of induction treatment (up to 28 weeks)
|
|
Percentage of Participants With End of Induction Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population
기간: 28 days after end of induction treatment (up to 28 weeks)
|
28 days after end of induction treatment (up to 28 weeks)
|
|
Percentage of Participants With Best Overall Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
기간: Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 79.5 months)
|
Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 79.5 months)
|
|
Percentage of Participants With Best Overall Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population
기간: Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 59.7 months)
|
Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 59.7 months)
|
|
Percentage of Participants With Best Overall Response of Complete Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
기간: Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 79.5 months)
|
Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 79.5 months)
|
|
Percentage of Participants With Best Overall Response of Complete Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population
기간: Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 59.7 months)
|
Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 59.7 months)
|
|
Number of Participants With Progression-Free Survival (PFS) Events (Disease Progression/Relapse or Death), According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
기간: Baseline up to disease progression or death (up to maximum observation time of 79.5 months)
|
Baseline up to disease progression or death (up to maximum observation time of 79.5 months)
|
|
Number of Participants With PFS Events (Disease Progression/Relapse or Death), According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population
기간: Baseline up to disease progression or death (up to maximum observation time of 59.7 months)
|
Baseline up to disease progression or death (up to maximum observation time of 59.7 months)
|
|
PFS, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
기간: Baseline up to disease progression or death (up to maximum observation time of 79.5 months)
|
Baseline up to disease progression or death (up to maximum observation time of 79.5 months)
|
|
PFS, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population
기간: Baseline up to disease progression or death (up to maximum observation time of 59.7 months)
|
Baseline up to disease progression or death (up to maximum observation time of 59.7 months)
|
|
Number of Participants With Event-Free Survival (EFS) Event (Disease Progression, Death, or Initiation of a New Anti-Lymphoma Therapy), According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
기간: Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)
|
Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)
|
|
Number of Participants With EFS Event (Disease Progression, Death, or Initiation of a New Anti-Lymphoma Therapy), According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
기간: Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 59.7 months)
|
Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 59.7 months)
|
|
EFS, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
기간: Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)
|
Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)
|
|
EFS, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population
기간: Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)
|
Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)
|
|
Pharmacokinetics of Obinutuzumab: Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Relapsed/Refractory Population
기간: Day 1 (Pre-infusion [0 hour {hr}], end of infusion [EOI, approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
Day 1 (Pre-infusion [0 hour {hr}], end of infusion [EOI, approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
|
Pharmacokinetics of Obinutuzumab: AUClast - First-line Population
기간: Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
|
Pharmacokinetics of Obinutuzumab: Maximum Observed Plasma Concentration (Cmax) - Relapsed/Refractory Population
기간: Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
|
Pharmacokinetics of Obinutuzumab: Cmax - First-line Population
기간: Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
|
Pharmacokinetics of Obinutuzumab: Systemic Clearance at Steady State (CLss) - Relapsed/Refractory Population
기간: Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
|
Pharmacokinetics of Obinutuzumab: CLss - First-line Population
기간: Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
|
Pharmacokinetics of Obinutuzumab: AUC From Time Zero to 7 Days (AUC7d) - Relapsed/Refractory Population
기간: Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
|
Pharmacokinetics of Obinutuzumab: AUC7d - First-line Population
기간: Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
|
Pharmacokinetics of Obinutuzumab: Volume of Distribution at Steady State (Vss) - Relapsed/Refractory Population
기간: Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
|
Pharmacokinetics of Obinutuzumab: Vss - First-line Population
기간: Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
|
Pharmacokinetics of Obinutuzumab: Plasma Half-life (t1/2) - Relapsed/Refractory Population
기간: Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
|
Pharmacokinetics of Obinutuzumab: t1/2 - First-line Population
기간: Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
|
Pharmacokinetics of Obinutuzumab: Plasma Trough Concentration (Ctrough) - Relapsed/Refractory Population
기간: Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
|
Pharmacokinetics of Obinutuzumab: Ctrough - First-line Population
기간: Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
|
|
Pharmacodynamics of Obinutuzumab: Number of Participants With Peripheral Blood B-cell Depletion - Relapsed/Refractory Population
기간: Cycle 1 Day 1 up to end of treatment (up to the maximum observation time of 79.5 months)
|
Cycle 1 Day 1 up to end of treatment (up to the maximum observation time of 79.5 months)
|
|
Pharmacodynamics of Obinutuzumab: Number of Participants With Peripheral Blood B-cell Depletion - First-line Population
기간: Cycle 1 Day 1 up to end of treatment (up to the maximum observation time of 59.7 months)
|
Cycle 1 Day 1 up to end of treatment (up to the maximum observation time of 59.7 months)
|
|
Pharmacodynamics of Obinutuzumab: Time From End of Treatment to B-Cell Recovery - Relapsed/Refractory Population
기간: From end of treatment to B-cell recovery (up to the maximum observation time of 79.5 months)
|
From end of treatment to B-cell recovery (up to the maximum observation time of 79.5 months)
|
|
Pharmacodynamics of Obinutuzumab: Time From End of Treatment to B-Cell Recovery - First-line Population
기간: From end of treatment to B-cell recovery (up to the maximum observation time of 59.7 months)
|
From end of treatment to B-cell recovery (up to the maximum observation time of 59.7 months)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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
- Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.
- Grigg A, Dyer MJ, Diaz MG, Dreyling M, Rule S, Lei G, Knapp A, Wassner-Fritsch E, Marlton P. Safety and efficacy of obinutuzumab with CHOP or bendamustine in previously untreated follicular lymphoma. Haematologica. 2017 Apr;102(4):765-772. doi: 10.3324/haematol.2016.152272. Epub 2016 Dec 23.
- Cartron G, Hourcade-Potelleret F, Morschhauser F, Salles G, Wenger M, Truppel-Hartmann A, Carlile DJ. Rationale for optimal obinutuzumab/GA101 dosing regimen in B-cell non-Hodgkin lymphoma. Haematologica. 2016 Feb;101(2):226-34. doi: 10.3324/haematol.2015.133421. Epub 2015 Dec 11.
- Radford J, Davies A, Cartron G, Morschhauser F, Salles G, Marcus R, Wenger M, Lei G, Wassner-Fritsch E, Vitolo U. Obinutuzumab (GA101) plus CHOP or FC in relapsed/refractory follicular lymphoma: results of the GAUDI study (BO21000). Blood. 2013 Aug 15;122(7):1137-43. doi: 10.1182/blood-2013-01-481341. Epub 2013 Jul 10.
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
2009년 2월 1일
기본 완료 (실제)
2015년 11월 1일
연구 완료 (실제)
2015년 11월 1일
연구 등록 날짜
최초 제출
2009년 1월 16일
QC 기준을 충족하는 최초 제출
2009년 1월 16일
처음 게시됨 (추정)
2009년 1월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 11월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 11월 3일
마지막으로 확인됨
2016년 11월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 면역계 질환
- 조직학적 유형에 따른 신생물
- 신생물
- 림프 증식 장애
- 림프계 질환
- 면역증식성 장애
- 림프종
- 림프종, 여포성
- 림프종, 비호지킨
- 약물의 생리적 효과
- 약리작용의 분자기전
- 효소 억제제
- 항염증제
- 항류마티스제
- 항종양제
- 면역억제제
- 면역학적 요인
- 튜불린 조절제
- 항유사분열제
- 유사분열 조절제
- 글루코 코르티코이드
- 호르몬
- 호르몬, 호르몬 대체물 및 호르몬 길항제
- 항종양제, 호르몬
- 항종양제, 알킬화제
- 알킬화제
- 골수 파괴 작용제
- 항종양제, 식물성
- 토포이소머라제 II 억제제
- 토포이소머라제 억제제
- 항종양제, 면역학적
- 항생제, 항종양제
- 사이클로포스파마이드
- 벤다무스틴 염산염
- 프레드니손
- 독소루비신
- 플루다라빈
- 빈크리스틴
- 오비누투주맙
기타 연구 ID 번호
- BO21000
- 2008-001643-19
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. .
비호지킨 림프종에 대한 임상 시험
-
Henan Cancer HospitalFundamenta Therapeutics, Ltd.아직 모집하지 않음Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited중국
-
Wael Elbanna ClinicFetal Medicine Research Center, Spain모병임신 여성: 1- ICSI-PGS 2- ICSI-non-PGS 3- 자연 임신 여성이집트
-
UPECLIN HC FM Botucatu Unesp완전한
-
UPECLIN HC FM Botucatu Unesp완전한
-
Fundacion para la Investigacion Biomedica del Hospital...Fundación Mutua Madrileña완전한간세포 암 | 후천면역결핍증후군 바이러스 | 간염, 바이러스, Non-A, Non-B, 비경구적으로 전염됨스페인
-
Mayo Clinic모병
-
UPECLIN HC FM Botucatu Unesp알려지지 않은HIV 감염 | 후천성 면역 결핍 증후군 | 간염, 바이러스, Non-A, Non-B, 비경구적으로 전염됨브라질
-
Fundamenta Therapeutics, Ltd.The First Affiliated Hospital of Zhengzhou University아직 모집하지 않음Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited
-
Holostem s.r.l.IRCCS San Raffaele; University of Modena and Reggio Emilia종료됨Junctional Epidermolysis Bullosa Non-Herlitz Type프랑스, 이탈리아
-
Millennium Pharmaceuticals, Inc.완전한GCB(Non-Germinal B-cell-like) 미만성 거대 B-세포 림프종(DLBCL)미국
오비누투주맙에 대한 임상 시험
-
Institute of Hematology & Blood Diseases Hospital...아직 모집하지 않음
-
Liling Zhang모병림프종 | 재발성/불응성 미만성 거대 B세포 림프종(DLBCL)중국
-
Cancer Institute and Hospital, Chinese Academy...모병
-
The First Affiliated Hospital with Nanjing Medical...모병
-
NeoTX Therapeutics Ltd.AstraZeneca모집하지 않고 적극적으로흑색종 | 신장 세포 암종 | 간세포 암 | 식도암 | 췌장 선암종 | 난소 암 | NSCLC | 전립선암 | 중피종 | 방광암 | 삼중 음성 유방암 | 자궁내막암 | 대장암 전이성 | 두경부 편평 세포 암종 | 요로상피암 | 자궁경부 편평 세포 암종 | 위식도암 | HER2 음성 유방암 | ER+ 유방암 | NSCL2 유전자 돌연변이이스라엘, 인도
-
Assistance Publique - Hôpitaux de Paris모병스테로이드 의존성 신증후군 | 스테로이드 민감성 신증후군프랑스
-
Bristol-Myers Squibb모병재발성/불응성 비호지킨 림프종미국, 프랑스, 스페인, 네덜란드, 스위스, 독일, 칠레, 중국, 그리스, 이탈리아, 일본, 대한민국, 영국
-
Molecular Partners AG모집하지 않고 적극적으로