Previously untreated patients with CD20-positive indolent lymphoma
Conditions
Interventions
investigational material(s)
Generic name etc : GA101(Obinutuzumab) + Chemotherapy
INN of investigational material : obinutuzumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Admin
followed by 1000 mg iv every 2 months in responders until disease progression, for up to 2 years / Chemotherapy :8 cycles (21-day cycles) or 6 cycles (28-day cycles)
control material(s)
Generic nam
followed by 375 mg/m2 iv every 2 months in responders until disease progression, for up to 2 year / Chemotherapy:8 cycles (21-day cycles) or 6 cycles (28-day cycles)
Sponsors
Chugai Pharmaceutical Co., Ltd.
Nippon Shinyaku Co., Ltd. (in Japan)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult patients, >/= 18 years of age - CD20-positive indolent B-cell non-Hodgkin's lymphoma (follicular lymphoma or splenic, nodal or extranodal marginal zone lymphoma) - Stage III or IV disease, or Stage II bulky disease, requiring treatment - At least one bi-dimensionally measurable lesion (>2 cm in its largest dimension by CT scan or MRI) - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 - Adequate hematologic function
Exclusion criteria
Exclusion criteria: - Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma - Grade 3b follicular lymphoma, small lymphocytic lymphoma or Waldenstrom's macroglobulinaemia - Ann Arbor Stage I disease - History of severe allergic or anaphylactic reactions to monoclonal antibody therapy, known hypersensitivity to any of the study drugs or sensitivity to murine products, or history of sensitivity to mannitol - For patients with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma with chemotherapy, immunotherapy, or radiotherapy - For patients with non-follicular lymphoma: prior treatment with chemotherapy or immunotherapy - History of prior malignancy with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix - Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1 - Positive for HIV, HTLV1, hepatitis C or chronic hepatitis B
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Endpoints:Progression-free survival in patients with follicular lymphoma, investigator-assessed according to the Revised Response Criteria for Malignant Lymphoma Method:Modified Revised Response Criteria for Malignant Lymphoma | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Endpoints:- Progression-free survival in the overall study population, investigator-assessed - Progression-free survival, Independent Review Committee - assessed - Response (overall response and complete response), investigator-assessed Response (overall response and complete response), Independent Review Committee - assessed - Overall survival - Event-free survival - Disease-free survival - Duration of response - Time to next anti-lymphoma treatment - Safety - Patient-reported outcomes (Functional Assessment of Cancer Therapy for Lymphoma scale, EuroQol EQ-5D questionnaire) - Medical resource utilization (hospitalizations, subsequent drug therapies, medical and surgical procedures) Method:Modified Revised Response Criteria for Malignant Lymphoma, CTCAE v4 | — |
Countries
Asia except Japan, Japan, North America, Oceania
Outcome results
None listed