A Study of Obinutuzumab in Combination With Chemotherapy in Participants With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma (GAUDI)
2016年11月3日 更新者：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.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
137
段階
- フェーズ 1
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
-
-
-
Leicester、イギリス、LE1 5WW
-
London、イギリス、SE5 9RS
-
Manchester、イギリス、M20 4QL
-
Plymouth、イギリス、PL6 8DH
-
Southampton、イギリス、SO16 6YD
-
Truro、イギリス、TR1 3LJ
-
-
-
-
Lazio
-
Roma、Lazio、イタリア、00161
-
-
Lombardia
-
Milano、Lombardia、イタリア、20132
-
-
Piemonte
-
Torino、Piemonte、イタリア、10126
-
-
-
-
New South Wales
-
Kogarah、New South Wales、オーストラリア、2217
-
Sydney、New South Wales、オーストラリア、2145
-
-
Queensland
-
Greenslopes、Queensland、オーストラリア、4120
-
Woolloongabba、Queensland、オーストラリア、4102
-
-
South Australia
-
Kurralta Park、South Australia、オーストラリア、5037
-
-
Victoria
-
Frankston、Victoria、オーストラリア、3199
-
Melbourne、Victoria、オーストラリア、3000
-
Melbourne、Victoria、オーストラリア、3084
-
-
-
-
-
Barcelona、スペイン、08036
-
Barcelona、スペイン、08003
-
Barcelona、スペイン、08035
-
Salamanca、スペイン、37007
-
Valencia、スペイン、46026
-
-
-
-
-
Aschaffenburg、ドイツ、63739
-
Freiburg、ドイツ、79106
-
Göttingen、ドイツ、37075
-
Heidelberg、ドイツ、69120
-
Kiel、ドイツ、24105
-
Köln、ドイツ、50924
-
Muenchen、ドイツ、81377
-
Ulm、ドイツ、89081
-
Würzburg、ドイツ、97080
-
-
-
-
-
Lille、フランス、59037
-
Montpellier、フランス、34295
-
Pierre Benite、フランス、69495
-
-
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:
- 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)
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：ランダム化
- 介入モデル：並列代入
- 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：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.
|
オビヌツズマブは、それぞれのアームで指定されたスケジュールに従って投与されます。
他の名前：
プレドニゾンは、それぞれのアームで指定されたスケジュールに従って投与されます。
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.
|
|
実験的：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.
|
オビヌツズマブは、それぞれのアームで指定されたスケジュールに従って投与されます。
他の名前：
プレドニゾンは、それぞれのアームで指定されたスケジュールに従って投与されます。
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.
|
|
実験的：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.
|
オビヌツズマブは、それぞれのアームで指定されたスケジュールに従って投与されます。
他の名前：
Cyclophosphamide will be administered as per schedule specified in the respective arm.
Fludarabine will be administered as per schedule specified in the respective arm.
|
|
実験的：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.
|
オビヌツズマブは、それぞれのアームで指定されたスケジュールに従って投与されます。
他の名前：
Cyclophosphamide will be administered as per schedule specified in the respective arm.
Fludarabine will be administered as per schedule specified in the respective arm.
|
|
実験的：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.
|
オビヌツズマブは、それぞれのアームで指定されたスケジュールに従って投与されます。
他の名前：
Bendamustine will be administered as per schedule specified in the respective arm.
|
|
実験的：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.
|
オビヌツズマブは、それぞれのアームで指定されたスケジュールに従って投与されます。
他の名前：
プレドニゾンは、それぞれのアームで指定されたスケジュールに従って投与されます。
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.
|
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 |
時間枠 |
|---|---|
|
Percentage of Participants With Adverse Events (AEs) - Relapsed/Refractory Population
時間枠：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
時間枠：Baseline up to maximum observation time of 59.7 months
|
Baseline up to maximum observation time of 59.7 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Percentage of Participants With End of Induction Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
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
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。
一般刊行物
- 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.
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
2009年2月1日
一次修了 (実際)
2015年11月1日
研究の完了 (実際)
2015年11月1日
試験登録日
最初に提出
2009年1月16日
QC基準を満たした最初の提出物
2009年1月16日
最初の投稿 (見積もり)
2009年1月19日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年11月4日
QC基準を満たした最後の更新が送信されました
2016年11月3日
最終確認日
2016年11月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
- 免疫系疾患
- 組織型別の新生物
- 新生物
- リンパ増殖性疾患
- リンパ疾患
- 免疫増殖性疾患
- リンパ腫
- リンパ腫、濾胞性
- リンパ腫、非ホジキン
- 薬の生理作用
- 薬理作用の分子機構
- 酵素阻害剤
- 抗炎症剤
- 抗リウマチ剤
- 抗悪性腫瘍薬
- 免疫抑制剤
- 免疫学的要因
- チューブリンモジュレーター
- 抗有糸分裂剤
- 有糸分裂モジュレーター
- グルココルチコイド
- ホルモン
- ホルモン、ホルモン代替物、およびホルモン拮抗薬
- 抗腫瘍剤、ホルモン剤
- 抗悪性腫瘍薬、アルキル化
- アルキル化剤
- 骨髄破壊的アゴニスト
- 抗悪性腫瘍剤、ファイトジェニック
- トポイソメラーゼ II 阻害剤
- トポイソメラーゼ阻害剤
- 抗悪性腫瘍剤、免疫
- 抗生物質、抗悪性腫瘍薬
- シクロホスファミド
- ベンダムスチン塩酸塩
- プレドニゾン
- ドキソルビシン
- フルダラビン
- ビンクリスチン
- オビヌツズマブ
その他の研究ID番号
- BO21000
- 2008-001643-19
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。