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A Study of Obinutuzumab in Combination With Chemotherapy in Participants With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma

NCT ID: NCT00825149

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide will be administered as per schedule specified in the respective arm.

Doxorubicin

Intervention Type DRUG

Doxorubicin will be administered as per schedule specified in the respective arm.

Obinutuzumab

Intervention Type DRUG

Obinutuzumab will be administered as per schedule specified in the respective arm.

Prednisone

Intervention Type DRUG

Prednisone will be administered as per schedule specified in the respective arm.

Vincristine

Intervention Type DRUG

Vincristine will be administered as per schedule specified in the respective arm.

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.

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide will be administered as per schedule specified in the respective arm.

Doxorubicin

Intervention Type DRUG

Doxorubicin will be administered as per schedule specified in the respective arm.

Obinutuzumab

Intervention Type DRUG

Obinutuzumab will be administered as per schedule specified in the respective arm.

Prednisone

Intervention Type DRUG

Prednisone will be administered as per schedule specified in the respective arm.

Vincristine

Intervention Type DRUG

Vincristine will be administered as per schedule specified in the respective arm.

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.

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide will be administered as per schedule specified in the respective arm.

Fludarabine

Intervention Type DRUG

Fludarabine will be administered as per schedule specified in the respective arm.

Obinutuzumab

Intervention Type DRUG

Obinutuzumab will be administered as per schedule specified in the respective arm.

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.

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide will be administered as per schedule specified in the respective arm.

Fludarabine

Intervention Type DRUG

Fludarabine will be administered as per schedule specified in the respective arm.

Obinutuzumab

Intervention Type DRUG

Obinutuzumab will be administered as per schedule specified in the respective arm.

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.

Group Type EXPERIMENTAL

Bendamustine

Intervention Type DRUG

Bendamustine will be administered as per schedule specified in the respective arm.

Obinutuzumab

Intervention Type DRUG

Obinutuzumab will be administered as per schedule specified in the respective arm.

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.

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide will be administered as per schedule specified in the respective arm.

Doxorubicin

Intervention Type DRUG

Doxorubicin will be administered as per schedule specified in the respective arm.

Obinutuzumab

Intervention Type DRUG

Obinutuzumab will be administered as per schedule specified in the respective arm.

Prednisone

Intervention Type DRUG

Prednisone will be administered as per schedule specified in the respective arm.

Vincristine

Intervention Type DRUG

Vincristine will be administered as per schedule specified in the respective arm.

Interventions

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Bendamustine

Bendamustine will be administered as per schedule specified in the respective arm.

Intervention Type DRUG

Cyclophosphamide

Cyclophosphamide will be administered as per schedule specified in the respective arm.

Intervention Type DRUG

Doxorubicin

Doxorubicin will be administered as per schedule specified in the respective arm.

Intervention Type DRUG

Fludarabine

Fludarabine will be administered as per schedule specified in the respective arm.

Intervention Type DRUG

Obinutuzumab

Obinutuzumab will be administered as per schedule specified in the respective arm.

Intervention Type DRUG

Prednisone

Prednisone will be administered as per schedule specified in the respective arm.

Intervention Type DRUG

Vincristine

Vincristine will be administered as per schedule specified in the respective arm.

Intervention Type DRUG

Other Intervention Names

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RO5072759

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Kogarah, New South Wales, Australia

Site Status

Sydney, New South Wales, Australia

Site Status

Greenslopes, Queensland, Australia

Site Status

Woolloongabba, Queensland, Australia

Site Status

Kurralta Park, South Australia, Australia

Site Status

Frankston, Victoria, Australia

Site Status

Melbourne, Victoria, Australia

Site Status

Melbourne, Victoria, Australia

Site Status

Lille, , France

Site Status

Montpellier, , France

Site Status

Pierre-Bénite, , France

Site Status

Aschaffenburg, , Germany

Site Status

Cologne, , Germany

Site Status

Freiburg im Breisgau, , Germany

Site Status

Göttingen, , Germany

Site Status

Heidelberg, , Germany

Site Status

Kiel, , Germany

Site Status

München, , Germany

Site Status

Ulm, , Germany

Site Status

Würzburg, , Germany

Site Status

Rome, Lazio, Italy

Site Status

Milan, Lombardy, Italy

Site Status

Turin, Piedmont, Italy

Site Status

Barcelona, Barcelona, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

Barcelona, Barcelona, Spain

Site Status

Salamanca, Salamanca, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Leicester, , United Kingdom

Site Status

London, , United Kingdom

Site Status

Manchester, , United Kingdom

Site Status

Plymouth, , United Kingdom

Site Status

Southampton, , United Kingdom

Site Status

Truro, , United Kingdom

Site Status

Countries

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Australia France Germany Italy Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 31050355 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28011903 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26659915 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23843495 (View on PubMed)

Other Identifiers

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2008-001643-19

Identifier Type: -

Identifier Source: secondary_id

BO21000

Identifier Type: -

Identifier Source: org_study_id