A Study of Obinutuzumab in Combination With Chemotherapy in Participants With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma (GAUDI)
3 listopada 2016 zaktualizowane przez: 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.
Przegląd badań
Status
Status
Zakończony
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
Zapisy
137
Faza
Faza
- Faza 1
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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New South Wales
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Kogarah, New South Wales, Australia, 2217
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Sydney, New South Wales, Australia, 2145
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Queensland
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Greenslopes, Queensland, Australia, 4120
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Woolloongabba, Queensland, Australia, 4102
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South Australia
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Kurralta Park, South Australia, Australia, 5037
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Victoria
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Frankston, Victoria, Australia, 3199
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Melbourne, Victoria, Australia, 3000
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Melbourne, Victoria, Australia, 3084
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Lille, Francja, 59037
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Montpellier, Francja, 34295
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Pierre Benite, Francja, 69495
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Barcelona, Hiszpania, 08036
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Barcelona, Hiszpania, 08003
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Barcelona, Hiszpania, 08035
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Salamanca, Hiszpania, 37007
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Valencia, Hiszpania, 46026
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Aschaffenburg, Niemcy, 63739
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Freiburg, Niemcy, 79106
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Göttingen, Niemcy, 37075
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Heidelberg, Niemcy, 69120
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Kiel, Niemcy, 24105
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Köln, Niemcy, 50924
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Muenchen, Niemcy, 81377
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Ulm, Niemcy, 89081
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Würzburg, Niemcy, 97080
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Lazio
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Roma, Lazio, Włochy, 00161
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Lombardia
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Milano, Lombardia, Włochy, 20132
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Piemonte
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Torino, Piemonte, Włochy, 10126
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Leicester, Zjednoczone Królestwo, LE1 5WW
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London, Zjednoczone Królestwo, SE5 9RS
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Manchester, Zjednoczone Królestwo, M20 4QL
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Plymouth, Zjednoczone Królestwo, PL6 8DH
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Southampton, Zjednoczone Królestwo, SO16 6YD
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Truro, Zjednoczone Królestwo, TR1 3LJ
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
6
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: 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.
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Obinutuzumab będzie podawany zgodnie ze schematem określonym w odpowiedniej grupie.
Inne nazwy:
Prednizon będzie podawany zgodnie ze schematem określonym w odpowiedniej grupie.
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.
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Eksperymentalny: 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.
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Obinutuzumab będzie podawany zgodnie ze schematem określonym w odpowiedniej grupie.
Inne nazwy:
Prednizon będzie podawany zgodnie ze schematem określonym w odpowiedniej grupie.
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.
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Eksperymentalny: 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.
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Obinutuzumab będzie podawany zgodnie ze schematem określonym w odpowiedniej grupie.
Inne nazwy:
Cyclophosphamide will be administered as per schedule specified in the respective arm.
Fludarabine will be administered as per schedule specified in the respective arm.
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Eksperymentalny: 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.
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Obinutuzumab będzie podawany zgodnie ze schematem określonym w odpowiedniej grupie.
Inne nazwy:
Cyclophosphamide will be administered as per schedule specified in the respective arm.
Fludarabine will be administered as per schedule specified in the respective arm.
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Eksperymentalny: 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.
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Obinutuzumab będzie podawany zgodnie ze schematem określonym w odpowiedniej grupie.
Inne nazwy:
Bendamustine will be administered as per schedule specified in the respective arm.
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Eksperymentalny: 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.
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Obinutuzumab będzie podawany zgodnie ze schematem określonym w odpowiedniej grupie.
Inne nazwy:
Prednizon będzie podawany zgodnie ze schematem określonym w odpowiedniej grupie.
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.
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
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Percentage of Participants With Adverse Events (AEs) - Relapsed/Refractory Population
Ramy czasowe: Baseline up to maximum observation time of 79.5 months
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Baseline up to maximum observation time of 79.5 months
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Percentage of Participants With AEs - First-line Population
Ramy czasowe: Baseline up to maximum observation time of 59.7 months
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Baseline up to maximum observation time of 59.7 months
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
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Percentage of Participants With End of Induction Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
Ramy czasowe: 28 days after end of induction treatment (up to 28 weeks)
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28 days after end of induction treatment (up to 28 weeks)
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Percentage of Participants With End of Induction Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population
Ramy czasowe: 28 days after end of induction treatment (up to 28 weeks)
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28 days after end of induction treatment (up to 28 weeks)
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Percentage of Participants With Best Overall Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
Ramy czasowe: Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 79.5 months)
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Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 79.5 months)
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Percentage of Participants With Best Overall Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population
Ramy czasowe: Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 59.7 months)
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Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 59.7 months)
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Percentage of Participants With Best Overall Response of Complete Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
Ramy czasowe: Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 79.5 months)
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Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 79.5 months)
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Percentage of Participants With Best Overall Response of Complete Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population
Ramy czasowe: Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 59.7 months)
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Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 59.7 months)
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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
Ramy czasowe: Baseline up to disease progression or death (up to maximum observation time of 79.5 months)
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Baseline up to disease progression or death (up to maximum observation time of 79.5 months)
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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
Ramy czasowe: Baseline up to disease progression or death (up to maximum observation time of 59.7 months)
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Baseline up to disease progression or death (up to maximum observation time of 59.7 months)
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PFS, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
Ramy czasowe: Baseline up to disease progression or death (up to maximum observation time of 79.5 months)
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Baseline up to disease progression or death (up to maximum observation time of 79.5 months)
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PFS, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population
Ramy czasowe: Baseline up to disease progression or death (up to maximum observation time of 59.7 months)
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Baseline up to disease progression or death (up to maximum observation time of 59.7 months)
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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
Ramy czasowe: Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)
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Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)
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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
Ramy czasowe: Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 59.7 months)
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Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 59.7 months)
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EFS, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
Ramy czasowe: Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)
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Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)
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EFS, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population
Ramy czasowe: Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)
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Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)
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Pharmacokinetics of Obinutuzumab: Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Relapsed/Refractory Population
Ramy czasowe: 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)
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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)
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Pharmacokinetics of Obinutuzumab: AUClast - First-line Population
Ramy czasowe: 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)
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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)
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Pharmacokinetics of Obinutuzumab: Maximum Observed Plasma Concentration (Cmax) - Relapsed/Refractory Population
Ramy czasowe: 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)
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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)
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Pharmacokinetics of Obinutuzumab: Cmax - First-line Population
Ramy czasowe: 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)
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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)
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Pharmacokinetics of Obinutuzumab: Systemic Clearance at Steady State (CLss) - Relapsed/Refractory Population
Ramy czasowe: 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)
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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)
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Pharmacokinetics of Obinutuzumab: CLss - First-line Population
Ramy czasowe: 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)
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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)
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Pharmacokinetics of Obinutuzumab: AUC From Time Zero to 7 Days (AUC7d) - Relapsed/Refractory Population
Ramy czasowe: 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)
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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)
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Pharmacokinetics of Obinutuzumab: AUC7d - First-line Population
Ramy czasowe: 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)
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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)
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Pharmacokinetics of Obinutuzumab: Volume of Distribution at Steady State (Vss) - Relapsed/Refractory Population
Ramy czasowe: 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)
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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)
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Pharmacokinetics of Obinutuzumab: Vss - First-line Population
Ramy czasowe: 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)
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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)
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Pharmacokinetics of Obinutuzumab: Plasma Half-life (t1/2) - Relapsed/Refractory Population
Ramy czasowe: 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)
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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)
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Pharmacokinetics of Obinutuzumab: t1/2 - First-line Population
Ramy czasowe: 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)
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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)
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Pharmacokinetics of Obinutuzumab: Plasma Trough Concentration (Ctrough) - Relapsed/Refractory Population
Ramy czasowe: 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)
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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)
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Pharmacokinetics of Obinutuzumab: Ctrough - First-line Population
Ramy czasowe: 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)
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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)
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Pharmacodynamics of Obinutuzumab: Number of Participants With Peripheral Blood B-cell Depletion - Relapsed/Refractory Population
Ramy czasowe: Cycle 1 Day 1 up to end of treatment (up to the maximum observation time of 79.5 months)
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Cycle 1 Day 1 up to end of treatment (up to the maximum observation time of 79.5 months)
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Pharmacodynamics of Obinutuzumab: Number of Participants With Peripheral Blood B-cell Depletion - First-line Population
Ramy czasowe: Cycle 1 Day 1 up to end of treatment (up to the maximum observation time of 59.7 months)
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Cycle 1 Day 1 up to end of treatment (up to the maximum observation time of 59.7 months)
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Pharmacodynamics of Obinutuzumab: Time From End of Treatment to B-Cell Recovery - Relapsed/Refractory Population
Ramy czasowe: From end of treatment to B-cell recovery (up to the maximum observation time of 79.5 months)
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From end of treatment to B-cell recovery (up to the maximum observation time of 79.5 months)
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Pharmacodynamics of Obinutuzumab: Time From End of Treatment to B-Cell Recovery - First-line Population
Ramy czasowe: From end of treatment to B-cell recovery (up to the maximum observation time of 59.7 months)
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From end of treatment to B-cell recovery (up to the maximum observation time of 59.7 months)
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Współpracownicy i badacze
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Sponsor
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Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
Rozpoczęcie studiów
1 lutego 2009
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
1 listopada 2015
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
1 listopada 2015
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
16 stycznia 2009
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
16 stycznia 2009
Pierwszy wysłany (Oszacować)
Pierwszy wysłany
19 stycznia 2009
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia wysłana aktualizacja
4 listopada 2016
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
3 listopada 2016
Ostatnia weryfikacja
Ostatnia weryfikacja
1 listopada 2016
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby układu odpornościowego
- Nowotwory według typu histologicznego
- Nowotwory
- Zaburzenia limfoproliferacyjne
- Choroby limfatyczne
- Zaburzenia immunoproliferacyjne
- Chłoniak
- Chłoniak, Pęcherzykowy
- Chłoniak nieziarniczy
- Fizjologiczne skutki leków
- Molekularne mechanizmy działania farmakologicznego
- Inhibitory enzymów
- Środki przeciwzapalne
- Środki przeciwreumatyczne
- Środki przeciwnowotworowe
- Środki immunosupresyjne
- Czynniki immunologiczne
- Modulatory tubuliny
- Środki antymitotyczne
- Modulatory mitozy
- Glikokortykosteroidy
- Hormony
- Hormony, substytuty hormonów i antagoniści hormonów
- Środki przeciwnowotworowe, hormonalne
- Środki przeciwnowotworowe, alkilujące
- Środki alkilujące
- Agoniści mieloablacyjni
- Środki przeciwnowotworowe, Fitogenne
- Inhibitory topoizomerazy II
- Inhibitory topoizomerazy
- Środki przeciwnowotworowe, immunologiczne
- Antybiotyki, Przeciwnowotworowe
- Cyklofosfamid
- Chlorowodorek bendamustyny
- Prednizon
- Doksorubicyna
- Fludarabina
- Winkrystyna
- Obinutuzumab
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- BO21000
- 2008-001643-19
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .