Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia

Phase 1

Completed

• Conditions: Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular
• Interventions: Drug: ofatumumab

• Registration Number: NCT00742144
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of ofatumumab monotherapy in Japanese follicular lymphoma (FL) or chronic lymphocytic leukemia (CLL) patients. subject will receive ofatumumab 8 weekly infusions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-27
• Study Start: 2008-09-19
• Primary Completion: 2009-11-18
• Study Completion: 2009-11-18
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ofatumumab	ofatumumab	Japanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia

Primary Outcome Measures

Name	Time	Method
tolerability	eight weeks

Secondary Outcome Measures

Name	Time	Method
Adverse event,Clinical laboratory tests,Immunoglobulin,HAHA,Objective response rate,Duration of response,Progression free survival,CD5,19,20,CD23 positive cells,Complement (CH50),PK parameters,	nine months

Trial Locations

Locations (1)

GSK Investigational Site; 🇯🇵 Tokyo, Japan