A Single-arm, International, Multi-center Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to Rituximab as Monotherapy or in Combination With Chemotherapy
Patients in the study will be randomized into two dose groups. Patients in each dose group
will receive one infusion of 300 mg of HuMax-CD20 followed by 7 weekly infusions of either
500 or 1000 mg of HuMax-CD20. Disease status will be assessed every 3 months until month
24.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Number of Participants With Objective Response (OR)
OR was assessed by an Independent endpoints Review Committee (IRC) according to the standardized response criteria for Non-Hodgkin's lymphoma. Participants with Complete Response (CR; complete disappearance of all detectable disease), Complete Response unconfirmed (CRu; any residual lymph node/nodal mass >1.5 centimeters [cm] in its longest transverse diameter that regressed >75% compared to baseline), or Partial Response (PR; >=50% decrease in the sum of the product of diameters of indicator lesions) were defined as responders for OR.
Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
United States: Food and Drug Administration
111772
NCT00394836
September 2006
September 2013
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