Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants Classified as Responders at Visit 26 (3 Months After Last Infusion of Ofatumumab)

Outcome Description:

An Independent Review Committee (IRC) assessed overall best response based on standardized response criteria for non-Hodgkin's Lymphomas (NHL) and classified the participants as responders and non-responders. Responders included participants with complete remission (CR; complete disappearance of all detectable clinical and radiographic evidence of disease), complete remission unconfirmed (CRu; more than a 75% decrease in lymph node [LN] size compared to baseline), and partial response (PR; >=50% decrease in LN size and evidence of new lesions).

Outcome Time Frame:

Maximum of 23 months after the start of treatment

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

111775

NCT ID:

NCT00494780

Start Date:

June 2007

Completion Date:

January 2014

Related Keywords:

• Lymphoma, Follicular
• CHOP (cyclophosphamide,doxorubicin,vincristine,prednisolone)
• ofatumumab
• Lymphoma
• Lymphoma, Follicular