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

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ClinicalTrials.gov Identifier: NCT00742144
Recruitment Status : Completed
First Posted : August 27, 2008
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular Drug: ofatumumab Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase I Study of Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia
Actual Study Start Date : September 19, 2008
Primary Completion Date : November 18, 2009
Study Completion Date : November 18, 2009

Arm Intervention/treatment
Experimental: ofatumumab
Japanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia
Drug: ofatumumab
Ofatumumab (GSK1841157), a clear colorless liquid, is supplied in a glass vial. Each vial contains 100mg of ofatumumab in 5mL.

Primary Outcome Measures :
  1. tolerability [ Time Frame: eight weeks ]

Secondary Outcome Measures :
  1. 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, [ Time Frame: nine months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Signed Informed Consent.
  • Histologically confirmed relapsed or refractory CD20 positive FL grade 1-3a and 1 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or CD5, CD19, CD20 and CD23 positive relapse or refractory CLL.
  • Subjects must have adequate blood, liver, and kidney function.
  • Subjects who passed the provided periods from the last anti-cancer treatments at screening
  • ECOG Performance Status of 0-2
  • Life expectancy more than 24 weeks at screening


  • Current and past malignancy other than FL and CLL within 5 years prior to screening.
  • Known Richter's transformation
  • Previous autologous stem cell transplantation within 24 weeks prior to screening
  • Previous allogeneic stem cell transplantation
  • Known CNS involvement
  • History of significant cerebrovascular disease
  • Current cardiac disease requiring medical treatment
  • Chronic or ongoing active infectious disease requiring systemic treatment
  • Patients with pleural effusion or ascites detectable by physical examination
  • Positive serology test for any of HBsAg, anti-HBc or anti-HCV
  • Known HIV positive
  • Pregnant or lactating women
  • Women of childbearing potential and male patients not willing to use adequate contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742144

GSK Investigational Site
Aichi, Japan, 466-8650
GSK Investigational Site
Tokyo, Japan, 104-0045
GSK Investigational Site
Tokyo, Japan, 135-8550
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00742144     History of Changes
Other Study ID Numbers: OMB111148
First Posted: August 27, 2008    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by GlaxoSmithKline:
CD20 positive
Chronic lymphocytic leukemia
Follicular lymphoma
Japanese patient

Additional relevant MeSH terms:
Lymphoma, Follicular
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs