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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00742144
First received: August 26, 2008
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

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 Intervention Phase
Follicular Lymphoma
Chronic Lymphocytic Leukemia
Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular
Drug: ofatumumab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Phase I Study of Ofatumumab (GSK1841157) in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • tolerability [ Time Frame: eight weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 6
Study Start Date: September 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • 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

EXCLUSION CRITERIA:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742144

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

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00742144     History of Changes
Other Study ID Numbers: OMB111148
Study First Received: August 26, 2008
Last Updated: May 31, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
CD20 positive
Chronic lymphocytic leukemia
Follicular lymphoma
GSK1841157
Japanese patient
Ofatumumab

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Follicular
Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on September 22, 2014