None listed
Conditions
Interventions
GA101 will be administered by IV infusion at an absolute (flat) dose of 1000 mg on Day 1 of each 21-day cycle for 8 cycles. During Cycle 1, GA101 will also be infused on Days 8 and 15. Administration
Sponsors
F. Hoffmann La Roche Ltd / Genentech Inc,
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: • * Patients in an IPI disease risk group that is one of the following: high, high-intermediate, or low-intermediate. Patients in the low-risk group are eligible but must have an IPI score of 1, irrespective of bulky disease or IPI score of 0 with bulky disease, defined as one lesion ≥ 7.5 cm. • At least one bi-dimensionally measurable lesion defined as > 1.5 cm in its largest dimension on CT scan, • Ability and willingness to comply with the study protocol procedures, • Age ≥ 18 years, • ECOG performance status of 0, 1, or 2 • LVEF ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram, • Adequate hematologic function.
Exclusion criteria
Exclusion criteria: • * Corticosteroid use > 30 mg/day of prednisone or equivalent, for purposesother than lymphoma symptom control. * Primary CNS lymphoma and secondary CNS involvement by lymphoma, MCL, or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, plasmablastic lymphoma, and primary cutaneous DLBCL. * Vaccination with live vaccines within 28 days prior to randomization. * Any investigational therapy within 28 days prior to the start of Cycle 1. * History of other malignancy that could affect compliance with the protocol or interpretation of results. * Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease. * Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis. * abnormal laboratory values.
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea North, Korea South, Lithuania, Macedonia, Mexico, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactJORGE MANUEL TIMOTEO
ROCHE FARMA (PERU) S.A.
Outcome results
None listed