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

This study is currently recruiting participants.

Verified by GlaxoSmithKline, November 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00742144

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	Drug: Ofatumumab injection vial	Phase I

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

Drug Information available for: Ofatumumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Phase I Study of Ofatumumab (GSK1841157) in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

tolerability

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,

Estimated Enrollment:	12
Study Start Date:	September 2008

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

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

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Locations

Japan
GSK Investigational Site	Recruiting
Tokyo, Japan, 135-8550
GSK Investigational Site	Recruiting
Aichi, Japan, 466-8650
GSK Investigational Site	Not yet recruiting
Tokyo, Japan, 104-0045

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	OMB111148
Study First Received:	August 26, 2008
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00742144
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

Ofatumumab
GSK1841157
Follicular lymphoma

Chronic lymphocytic leukemia
Japanese patient
CD20 positive

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Lymphoma, Follicular
Leukemia
Lymphatic Diseases

Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009