A Study of Obinutuzumab in Combination With Chemotherapy in Participants With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma (GAUDI)
3 november 2016 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Ingrijpend
Inschrijving (Werkelijk)
137
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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New South Wales
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Kogarah, New South Wales, Australië, 2217
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Sydney, New South Wales, Australië, 2145
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Queensland
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Greenslopes, Queensland, Australië, 4120
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Woolloongabba, Queensland, Australië, 4102
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South Australia
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Kurralta Park, South Australia, Australië, 5037
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Victoria
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Frankston, Victoria, Australië, 3199
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Melbourne, Victoria, Australië, 3000
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Melbourne, Victoria, Australië, 3084
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Aschaffenburg, Duitsland, 63739
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Freiburg, Duitsland, 79106
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Göttingen, Duitsland, 37075
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Heidelberg, Duitsland, 69120
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Kiel, Duitsland, 24105
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Köln, Duitsland, 50924
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Muenchen, Duitsland, 81377
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Ulm, Duitsland, 89081
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Würzburg, Duitsland, 97080
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Lille, Frankrijk, 59037
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Montpellier, Frankrijk, 34295
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Pierre Benite, Frankrijk, 69495
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Lazio
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Roma, Lazio, Italië, 00161
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Lombardia
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Milano, Lombardia, Italië, 20132
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Piemonte
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Torino, Piemonte, Italië, 10126
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Barcelona, Spanje, 08036
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Barcelona, Spanje, 08003
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Barcelona, Spanje, 08035
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Salamanca, Spanje, 37007
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Valencia, Spanje, 46026
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Leicester, Verenigd Koninkrijk, LE1 5WW
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London, Verenigd Koninkrijk, SE5 9RS
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Manchester, Verenigd Koninkrijk, M20 4QL
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Plymouth, Verenigd Koninkrijk, PL6 8DH
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Southampton, Verenigd Koninkrijk, SO16 6YD
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Truro, Verenigd Koninkrijk, TR1 3LJ
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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 zal worden toegediend volgens het schema dat is gespecificeerd in de respectieve arm.
Andere namen:
Prednison zal worden toegediend volgens het schema dat is gespecificeerd in de respectieve arm.
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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Experimenteel: 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 zal worden toegediend volgens het schema dat is gespecificeerd in de respectieve arm.
Andere namen:
Prednison zal worden toegediend volgens het schema dat is gespecificeerd in de respectieve arm.
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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Experimenteel: 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 zal worden toegediend volgens het schema dat is gespecificeerd in de respectieve arm.
Andere namen:
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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Experimenteel: 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 zal worden toegediend volgens het schema dat is gespecificeerd in de respectieve arm.
Andere namen:
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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Experimenteel: 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 zal worden toegediend volgens het schema dat is gespecificeerd in de respectieve arm.
Andere namen:
Bendamustine will be administered as per schedule specified in the respective arm.
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Experimenteel: 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 zal worden toegediend volgens het schema dat is gespecificeerd in de respectieve arm.
Andere namen:
Prednison zal worden toegediend volgens het schema dat is gespecificeerd in de respectieve arm.
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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Percentage of Participants With Adverse Events (AEs) - Relapsed/Refractory Population
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 februari 2009
Primaire voltooiing (Werkelijk)
1 november 2015
Studie voltooiing (Werkelijk)
1 november 2015
Studieregistratiedata
Eerst ingediend
16 januari 2009
Eerst ingediend dat voldeed aan de QC-criteria
16 januari 2009
Eerst geplaatst (Schatting)
19 januari 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
4 november 2016
Laatste update ingediend die voldeed aan QC-criteria
3 november 2016
Laatst geverifieerd
1 november 2016
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Neoplasmata
- Lymfoproliferatieve aandoeningen
- Lymfatische ziekten
- Immunoproliferatieve aandoeningen
- Lymfoom
- Lymfoom, folliculair
- Lymfoom, non-Hodgkin
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Ontstekingsremmende middelen
- Antireumatische middelen
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Glucocorticoïden
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Antineoplastische middelen, hormonaal
- Antineoplastische middelen, alkylering
- Alkyleringsmiddelen
- Myeloablatieve agonisten
- Antineoplastische middelen, fytogeen
- Topoisomerase II-remmers
- Topoisomeraseremmers
- Antineoplastische middelen, immunologisch
- Antibiotica, antineoplastiek
- Cyclofosfamide
- Bendamustine Hydrochloride
- Prednison
- Doxorubicine
- Fludarabine
- Vincristine
- Obinutuzumab
Andere studie-ID-nummers
- BO21000
- 2008-001643-19
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .