This is a multicenter, phase 2, randomized trial to evaluate the efficacy and safety of obinutuzumab with CHOP versus obinutuzumab with bendamustine in treatment-naïve follicular lymphoma (Grade 3A) patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
133
1000mg i.v., administered on Day 1/8/15 (D1/8/15) of Cycle 1 (C1), and D1 of C2-6
a) Cyclophosphamide: 750 mg/m2 i.v. drip, administered on D1; b) Doxorubicin: 50 mg/m2 i.v. drip (or Epirubicin: 70mg/m2 i.v. drip), administered on D1; c) Vincristine: 1.4 mg/m2 i.v., administered on D1; d) Prednisone: 100mg/d po, administered on D1-5.
90 mg/m2 i.v. drip, administered on D1-2.
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, China
Progression-Free Survival (PFS)
From study entry to the first documented disease progression or death from any cause.
Time frame: Assessed up to 5 years.
Complete Response (CR)
Defined as the proportion of patients who achieve complete remission at the end of induction therapy.
Time frame: Up to 6 cycles (up to 24 weeks).
Objective Response Rate (ORR)
The proportion of patients who achieve complete remission (CR) or partial remission (PR) at the end of induction therapy.
Time frame: Up to 6 cycles (up to 24 weeks).
Event-Free Survival (EFS)
From study entry to the first occurrence of any event, including disease progression, discontinuation of treatment, or death for any reason.
Time frame: Assessed up to 5 years.
Overall Survival (OS)
From study entry to death from any cause.
Time frame: Assessed up to 5 years.
Progression of Disease within 24 months (POD24)
The occurrence of disease progression or relapse within 24 months from the date of enrollment.
Time frame: 24 months.
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