A Study of Obinutuzumab in Combination With Chemotherapy in Participants With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma
GAUDI
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
2 other identifiers
interventional
137
6 countries
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2009
Longer than P75 for phase_1
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2009
CompletedFirst Posted
Study publicly available on registry
January 19, 2009
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedNovember 4, 2016
November 1, 2016
6.8 years
January 16, 2009
November 3, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Adverse Events (AEs) - Relapsed/Refractory Population
Baseline up to maximum observation time of 79.5 months
Percentage of Participants With AEs - First-line Population
Baseline up to maximum observation time of 59.7 months
Secondary Outcomes (32)
Percentage of Participants With End of Induction Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
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
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
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
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
Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 79.5 months)
- +27 more secondary outcomes
Study Arms (6)
A: R/R FL: Obinutuzumab Low Dose + CHOP
EXPERIMENTALParticipants 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.
B: R/R FL: Obinutuzumab High Dose + CHOP
EXPERIMENTALParticipants 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.
C: R/R FL: Obinutuzumab Low Dose + FC
EXPERIMENTALParticipants 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.
D: R/R FL: Obinutuzumab High Dose + FC
EXPERIMENTALParticipants 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.
E: First-Line FL: Obinutuzumab + Bendamustine
EXPERIMENTALParticipants 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.
F: First-Line FL: Obinutuzumab + CHOP
EXPERIMENTALParticipants 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.
Interventions
Bendamustine will be administered as per schedule specified in the respective 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.
Fludarabine will be administered as per schedule specified in the respective arm.
Obinutuzumab will be administered as per schedule specified in the respective arm.
Prednisone will be administered as per schedule specified in the respective arm.
Vincristine will be administered as per schedule specified in the respective arm.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Unknown Facility
Kogarah, New South Wales, 2217, Australia
Unknown Facility
Sydney, New South Wales, 2145, Australia
Unknown Facility
Greenslopes, Queensland, 4120, Australia
Unknown Facility
Woolloongabba, Queensland, 4102, Australia
Unknown Facility
Kurralta Park, South Australia, 5037, Australia
Unknown Facility
Frankston, Victoria, 3199, Australia
Unknown Facility
Melbourne, Victoria, 3000, Australia
Unknown Facility
Melbourne, Victoria, 3084, Australia
Unknown Facility
Lille, 59037, France
Unknown Facility
Montpellier, 34295, France
Unknown Facility
Pierre-Bénite, 69495, France
Unknown Facility
Aschaffenburg, 63739, Germany
Unknown Facility
Cologne, 50924, Germany
Unknown Facility
Freiburg im Breisgau, 79106, Germany
Unknown Facility
Göttingen, 37075, Germany
Unknown Facility
Heidelberg, 69120, Germany
Unknown Facility
Kiel, 24105, Germany
Unknown Facility
München, 81377, Germany
Unknown Facility
Ulm, 89081, Germany
Unknown Facility
Würzburg, 97080, Germany
Unknown Facility
Rome, Lazio, 00161, Italy
Unknown Facility
Milan, Lombardy, 20132, Italy
Unknown Facility
Turin, Piedmont, 10126, Italy
Unknown Facility
Barcelona, Barcelona, 08003, Spain
Unknown Facility
Barcelona, Barcelona, 08035, Spain
Unknown Facility
Barcelona, Barcelona, 08036, Spain
Unknown Facility
Salamanca, Salamanca, 37007, Spain
Unknown Facility
Valencia, Valencia, 46026, Spain
Unknown Facility
Leicester, LE1 5WW, United Kingdom
Unknown Facility
London, SE5 9RS, United Kingdom
Unknown Facility
Manchester, M20 4QL, United Kingdom
Unknown Facility
Plymouth, PL6 8DH, United Kingdom
Unknown Facility
Southampton, SO16 6YD, United Kingdom
Unknown Facility
Truro, TR1 3LJ, United Kingdom
Related Publications (4)
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.
PMID: 31050355DERIVEDGrigg 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.
PMID: 28011903DERIVEDCartron 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.
PMID: 26659915DERIVEDRadford 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.
PMID: 23843495DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2009
First Posted
January 19, 2009
Study Start
February 1, 2009
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
November 4, 2016
Record last verified: 2016-11