Skip to main content
OpenTrials
Completed

NCT Number: NCT00825149

A Study of Obinutuzumab in Combination With Chemotherapy in Participants 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-Hodgkin's Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kogarah, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bendamustine

Drug

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

Cyclophosphamide

Drug

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

Doxorubicin

Drug

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

Fludarabine

Drug

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

Obinutuzumab

Drug

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

Other names: RO5072759

Prednisone

Drug

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

Vincristine

Drug

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

Primary outcomes

  1. Percentage of Participants With Adverse Events (AEs) - Relapsed/Refractory Population

    Time frame: Baseline up to maximum observation time of 79.5 months

  2. Percentage of Participants With AEs - First-line Population

    Time frame: Baseline up to maximum observation time of 59.7 months

Secondary outcomes

  1. Percentage of Participants With End of Induction Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population

    Time frame: 28 days after end of induction treatment (up to 28 weeks)

  2. Percentage of Participants With End of Induction Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population

    Time frame: 28 days after end of induction treatment (up to 28 weeks)

  3. Percentage of Participants With Best Overall Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population

    Time frame: Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 79.5 months)

  4. Percentage of Participants With Best Overall Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population

    Time frame: Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 59.7 months)

  5. Percentage of Participants With Best Overall Response of Complete Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population

    Time frame: Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 79.5 months)

  6. Percentage of Participants With Best Overall Response of Complete Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population

    Time frame: Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 59.7 months)

  7. 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

    Time frame: Baseline up to disease progression or death (up to maximum observation time of 79.5 months)

  8. 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

    Time frame: Baseline up to disease progression or death (up to maximum observation time of 59.7 months)

  9. PFS, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population

    Time frame: Baseline up to disease progression or death (up to maximum observation time of 79.5 months)

  10. PFS, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population

    Time frame: Baseline up to disease progression or death (up to maximum observation time of 59.7 months)

  11. 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

    Time frame: Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)

  12. 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

    Time frame: Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 59.7 months)

  13. EFS, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population

    Time frame: Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)

  14. EFS, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population

    Time frame: Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)

  15. Pharmacokinetics of Obinutuzumab: Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Relapsed/Refractory Population

    Time frame: 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)

  16. Pharmacokinetics of Obinutuzumab: AUClast - First-line Population

    Time frame: 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)

  17. Pharmacokinetics of Obinutuzumab: Maximum Observed Plasma Concentration (Cmax) - Relapsed/Refractory Population

    Time frame: 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)

  18. Pharmacokinetics of Obinutuzumab: Cmax - First-line Population

    Time frame: 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)

  19. Pharmacokinetics of Obinutuzumab: Systemic Clearance at Steady State (CLss) - Relapsed/Refractory Population

    Time frame: 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)

  20. Pharmacokinetics of Obinutuzumab: CLss - First-line Population

    Time frame: 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)

  21. Pharmacokinetics of Obinutuzumab: AUC From Time Zero to 7 Days (AUC7d) - Relapsed/Refractory Population

    Time frame: 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)

  22. Pharmacokinetics of Obinutuzumab: AUC7d - First-line Population

    Time frame: 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)

  23. Pharmacokinetics of Obinutuzumab: Volume of Distribution at Steady State (Vss) - Relapsed/Refractory Population

    Time frame: 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)

  24. Pharmacokinetics of Obinutuzumab: Vss - First-line Population

    Time frame: 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)

  25. Pharmacokinetics of Obinutuzumab: Plasma Half-life (t1/2) - Relapsed/Refractory Population

    Time frame: 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)

  26. Pharmacokinetics of Obinutuzumab: t1/2 - First-line Population

    Time frame: 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)

  27. Pharmacokinetics of Obinutuzumab: Plasma Trough Concentration (Ctrough) - Relapsed/Refractory Population

    Time frame: 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)

  28. Pharmacokinetics of Obinutuzumab: Ctrough - First-line Population

    Time frame: 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)

  29. Pharmacodynamics of Obinutuzumab: Number of Participants With Peripheral Blood B-cell Depletion - Relapsed/Refractory Population

    Time frame: Cycle 1 Day 1 up to end of treatment (up to the maximum observation time of 79.5 months)

  30. Pharmacodynamics of Obinutuzumab: Number of Participants With Peripheral Blood B-cell Depletion - First-line Population

    Time frame: Cycle 1 Day 1 up to end of treatment (up to the maximum observation time of 59.7 months)

  31. Pharmacodynamics of Obinutuzumab: Time From End of Treatment to B-Cell Recovery - Relapsed/Refractory Population

    Time frame: From end of treatment to B-cell recovery (up to the maximum observation time of 79.5 months)

  32. Pharmacodynamics of Obinutuzumab: Time From End of Treatment to B-Cell Recovery - First-line Population

    Time frame: From end of treatment to B-cell recovery (up to the maximum observation time of 59.7 months)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: GAUDI

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jan 19, 2009
Registry last updated
Nov 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.