Overview

This trial is active, not recruiting.

Condition lymphoma, b-cell
Treatments chop chemotherapy, ro5072759, rituximab [mabthera/rituxan]
Phase phase 3
Target CD20
Sponsor Hoffmann-La Roche
Collaborator Fondazione Italiana Linfomi ONLUS
Start date July 2011
End date August 2015
Trial size 1418 participants
Trial identifier NCT01287741, 2010-024194-39, BO21005

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
chop chemotherapy
CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisolone) iv every 21 days, 6 or 8 cycles
ro5072759 GA101
1000 mg iv every 21 days, 8 cycles (additional doses Days 8 and 15 of Cycle 1)
(Active Comparator)
chop chemotherapy
CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisolone) iv every 21 days, 6 or 8 cycles
rituximab [mabthera/rituxan]
375 mg/m2 iv every 21 days, 8 cycles

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Overall survival
time frame: up to approximately 78 months
Overall response rate at the end of treatment, assessed by the investigator and the Independent Review Committee (IRC)
time frame: 24 weeks
Complete response rate at the end of treatment, assessed by investigator and IRC
time frame: 24 weeks
Progression-free survival assessed by the Independent Review Committee
time frame: up to approximately 78 months
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
Disease-free survival, assessed by investigator
time frame: up to approximately 78 months
Duration of response, assessed by the investigator
time frame: up to approximately 78 months
Time to next lymphoma treatment
time frame: up to approximately 78 months
Safety: Incidence of adverse events
time frame: up to approximately 78 months
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
Medical resource utilization (hospitalizations, drug therapies, medical and surgical procedures and treatments)
time frame: up to approximately 78 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.