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A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fondazione Italiana Linfomi ONLUS
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01287741
First received: January 31, 2011
Last updated: October 20, 2016
Last verified: October 2016
  Purpose
This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.

Condition Intervention Phase
Diffuse Large B-Cell Lymphoma
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Obinutuzumab
Drug: Prednisolone
Drug: Rituximab
Drug: Vincristine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Open-Label Randomized Trial Comparing the Efficacy of GA101 (RO5072759) in Combination With CHOP (G-CHOP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-Positive Diffuse Large B-Cell Lymphoma (DLBCL)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-Free Survival, Assessed by the Investigator According to a Modified Version of the Revised Response Criteria for Malignant Lymphoma [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 64 months) ]
  • Progression-Free Survival, Assessed by the Independent Review Committee (IRC) According to a Modified Version of the Revised Response Criteria for Malignant Lymphoma [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 64 months) ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Baseline up to death (up to approximately 64 months) ]
  • Percentage of Participants With Overall Response, Assessed by the Investigator According to a Modified Version of the Revised Response Criteria for Malignant Lymphoma [ Time Frame: Baseline up to disease progression or death, whichever occurs first up to end of treatment (up to Month 6) ]
  • Percentage of Participants With Overall Response, Assessed by the Independent Review Committee (IRC) According to a Modified Version of the Revised Response Criteria for Malignant Lymphoma [ Time Frame: Baseline up to disease progression or death, whichever occurs first up to end of treatment (up to Month 6) ]
  • Percentage of Participants With Complete Response at the End of Treatment, Assessed by Investigator According to a Modified Version of the Revised Response Criteria for Malignant Lymphoma [ Time Frame: Baseline up to disease progression or death, whichever occurs first up to end of treatment (up to Month 6) ]
  • Percentage of Participants With Complete Response at the End of Treatment, Assessed by IRC According to a Modified Version of the Revised Response Criteria for Malignant Lymphoma [ Time Frame: Baseline up to disease progression or death, whichever occurs first up to end of treatment (up to Month 6) ]
  • Event-Free Survival According to a Modified Version of the Revised Response Criteria for Malignant Lymphoma [ Time Frame: Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurs first (up to approximately 64 months) ]
  • Disease-Free survival, Assessed by Investigator According to a Modified Version of the Revised Response Criteria for Malignant Lymphoma [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 64 months) ]
  • Duration of Response, Assessed by the Investigator According to a Modified Version of the Revised Response Criteria for Malignant Lymphoma [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 64 months) ]
  • Time to Next Anti-Lymphoma Treatment [ Time Frame: Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurs first (up to approximately 64 months) ]
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 64 months ]
  • Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab Among First 100 Randomized Participants [ Time Frame: Pre-dose (Hour 0) on Cycle (C) 1 Day (D) 1, C4D1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days) ]
  • Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma Subscale Score [ Time Frame: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 64 months (cycle length = 21 days) ]
  • Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Score [ Time Frame: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 64 months (cycle length = 21 days) ]
  • Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 Domain Scores [ Time Frame: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 64 months (cycle length = 21 days) ]
  • Medical Resource Utilization: Percentage of Participants Who Are Hospitalized [ Time Frame: Baseline up to approximately 64 months ]
  • Progression-Free Survival, Assessed by the IRC According to a Modified Version of the Revised Response Criteria for Malignant Lymphoma [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 64 months) ]
  • Medical Resource Utilization: Length of Hospital Stay [ Time Frame: Baseline up to approximately 64 months ]
  • Medical Resource Utilization: Percentage of Participants Who Use Any Subsequent Drug Therapy [ Time Frame: Baseline up to approximately 64 months ]
  • Medical Resource Utilization: Percentage of Participants Who Undergo Medical and Surgical Procedures [ Time Frame: Baseline up to approximately 64 months ]
  • Medical Resource Utilization: Percentage of Participants Who Receive Medical Treatments [ Time Frame: Baseline up to approximately 64 months ]
  • Trough Concentration of Obinutuzumab in Japanese Participants [ Time Frame: Pre-infusion (within 1 day before administration) on D1 of Cycles 1, 2, 4, 6, 8 & on Days 8, 15 of C1 (cycle length = 21 days) ]
  • Clearance of Obinutuzumab in Japanese Participants [ Time Frame: Pre-infusion (within 1 day before administration), within 1 hour after end of infusion (infusion duration = minimum 4 hours) on D1 of Cycles 1, 2, 4, 6, 8 & on Days 8, 15 of C1 (cycle length = 21 days); 20-28 & 66-80 hours after end of C1D1 infusion ]

Enrollment: 1418
Study Start Date: July 2011
Estimated Study Completion Date: November 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Obinutuzumab+CHOP
Participants will receive obinutuzumab IV every 21 days, (additional doses on Days 8 and 15 of Cycle 1) followed by CHOP chemotherapy every 21 days, for 6 or 8 cycles. If only 6 cycles of CHOP chemotherapy are to administered, then Cycles 7 and 8 of obinutuzumab will be given as monotherapy on every 21 days.
Drug: Cyclophosphamide
Participants will receive cyclophosphamide on Day 1 of each cycle (750 mg/m^2 IV) every 21 days, for 6 or 8 cycles.
Drug: Doxorubicin
Participants will receive doxorubicin on Day 1 of each cycle (50 mg/m^2 IV) every 21 days, for 6 or 8 cycles.
Drug: Obinutuzumab
Participants will receive 1000 mg IV every 21 days, for 8 cycles (additional doses on Days 8 and 15 of Cycle 1).
Other Name: GA101; RO5072759
Drug: Prednisolone
Participants will receive prednisolone on Day 1-5 of each cycle (100 mg/day orally) every 21 days, for 6 or 8 cycles.
Drug: Vincristine
Participants will receive vincristine on Day 1 of each cycle (1.4 to 2.0 mg/m^2 IV push every 21 days, for 6 or 8 cycles.
Active Comparator: Rituximab+CHOP
Participants will receive rituximab IV every 21 days, followed by CHOP chemotherapy every 21 days, for 6 or 8 cycles. If only 6 cycles of CHOP chemotherapy are to administered, then Cycles 7 and 8 of rituximab will be given as monotherapy on every 21 days.
Drug: Cyclophosphamide
Participants will receive cyclophosphamide on Day 1 of each cycle (750 mg/m^2 IV) every 21 days, for 6 or 8 cycles.
Drug: Doxorubicin
Participants will receive doxorubicin on Day 1 of each cycle (50 mg/m^2 IV) every 21 days, for 6 or 8 cycles.
Drug: Prednisolone
Participants will receive prednisolone on Day 1-5 of each cycle (100 mg/day orally) every 21 days, for 6 or 8 cycles.
Drug: Rituximab
Participants will receive 375 mg/m^2 IV every 21 days, for 8 cycles.
Other Name: MabThera/Rituxan
Drug: Vincristine
Participants will receive vincristine on Day 1 of each cycle (1.4 to 2.0 mg/m^2 IV push every 21 days, for 6 or 8 cycles.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously untreated CD20-positive DLBCL
  • At least 1 bi-dimensionally measurable lesion (greater than [>]1.5 centimeters [cm] in its largest dimension on the computed tomography [CT] scan)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Adequate hematological function
  • Low-intermediate, intermediate or high-risk International Prognostic Index (IPI) score (low-risk IPI score: IPI 1 irrespective of bulky disease or IPI 0 with bulky disease, defined as one lesion greater than equal to (>/=) 7.5 cm)
  • Left ventricular ejection fraction (LVEF) >/=50 percent (%) on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram

Exclusion Criteria:

  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products or to any component of CHOP or obinutuzumab
  • Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
  • Participants with transformed lymphoma and patients with follicular lymphoma IIIB
  • Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation
  • Prior treatment with cytotoxic drugs or rituximab for another condition (for example, rheumatoid arthritis) or prior use of an anti-CD20 antibody
  • Prior use of any monoclonal antibody within 3 months of the start of Cycle 1
  • Corticosteroid use of >30 milligrams per day (mg/day) of prednisone or equivalent, for purposes other than lymphoma symptom control
  • Primary central nervous system (CNS) lymphoma and secondary CNS involvement by lymphoma, mantle-cell lymphoma (MCL), or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, plasmablastic lymphoma, and primary cutaneous DLBCL
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287741

  Show 230 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Fondazione Italiana Linfomi ONLUS
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01287741     History of Changes
Other Study ID Numbers: BO21005
2010-024194-39
Study First Received: January 31, 2011
Last Updated: October 20, 2016

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Rituximab
Liposomal doxorubicin
Obinutuzumab
Doxorubicin
Vincristine
Prednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 26, 2017