A Study of RO5072759 (GA101) in Combination With CHOP Chemotherapy Versus MabThera/Rituxan (Rituximab) With CHOP in Patients With CD20-Positive Diffuse Large B-Cell Lymphoma

This study is currently recruiting participants.
Verified August 2012 by Hoffmann-La Roche

First Received on January 31, 2011.  
Last Updated on August 15, 2012  
History of Changes
This Clinical Trial Sponsored By: Hoffmann-La Roche
Collaborator: Fondazione Italiana Linfomi (FIL)
Information provided by (Responsible Party): Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01287741
 

Purpose for Clinical Trial

This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with CHOP chemotherapy versus MabThera/Rituxan (rituximab) with CHOP in previously untreated patients with CD20-positive diffuse large B-cell lymphoma. Patients will be randomized to receive either obinutuzumab 1000 mg intravenously (iv) every 21 days or MabThera/Rituxan 375 mg/m2 iv every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisolone) iv every 21 days. Anticipated time on study treatment is 24 weeks.

Condition Study Intervention Clinical Trial Phase
Lymphoma, B-Cell Drug: RO5072759
Drug: rituximab [MabThera/Rituxan]
Drug: CHOP chemotherapy
Phase 3

Study Type: Study Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Study 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:

MedlinePlus related topics:
Cancer
Lymphoma
Drug Information available for:
Rituximab

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures For Clinical Trial:

  • Progression-free survival, assessed by the investigator according to a modified version of the Revised Response Criteria for Malignant Lymphoma [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • Overall survival [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
  • Overall response rate at the end of treatment, assessed by the investigator and the Independent Review Committee (IRC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Complete response rate at the end of treatment, assessed by investigator and IRC [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Progression-free survival assessed by the Independent Review Committee [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
  • Event-free survival, defined as time to progression or relapse, or initiation of non-protocol-specified anti-lymphoma therapy, or death, whichever occurs first [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
  • Disease-free survival, assessed by investigator [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
  • Duration of response, assessed by the investigator [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
  • Time to next lymphoma treatment [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
  • Quality of life (Functional Assessment of Cancer Therapy-Lymphoma subscale, Euro-Quality of Life 5D questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Core 30) [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
  • Medical resource utilization (hospitalizations, drug therapies, medical and surgical procedures and treatments) [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1400
Study Start Date: July 2011
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: G-CHOP Drug: RO5072759

1000 mg iv every 21 days, 8 cycles (additional doses Days 8 and 15 of Cycle 1)
Other Name: GA101

Drug: CHOP chemotherapy

CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisolone) iv every 21 days, 6 or 8 cycles
Active Comparator: R-CHOP Drug: rituximab [MabThera/Rituxan]

375 mg/m2 iv every 21 days, 8 cycles

Drug: CHOP chemotherapy

CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisolone) iv every 21 days, 6 or 8 cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL)
  • At least 1 bi-dimensionally measurable lesion (>1.5 cm in is largest dimension on the CT scan)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Adequate hematological function
  • Low-intermediate, intermediate or high-risk IPI score (low-risk IPI score: IPI 1 irrespective of bulky disease or IPI 0 with bulky disease, defined as one lesion >/= 7.5 cm)

Exclusion Criteria:

  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
  • Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
  • Patients 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 (e.g., 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
  • Ongoing corticosteroid use of > 30 mg/day of prednisone or equivalent
  • Primary CNS lymphoma, blastic variant of mantle-cell lymphoma, or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, and primary cutaneous DLBCL
  • Positive for HIV
  • Active hepatitis B or C infection
  Contacts and Locations

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