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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 26, 2008

Last Updated Date

May 31, 2012

Start Date ^ICMJE

September 2008

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

tolerability [ Time Frame: eight weeks ]

Original Primary Outcome Measures ^ICMJE

tolerability

Change History

Complete list of historical versions of study NCT00742144 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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,

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open-label Phase I Study of Ofatumumab (GSK1841157) in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Follicular Lymphoma
Chronic Lymphocytic Leukemia
Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular

Intervention ^ICMJE

Drug: ofatumumab

Ofatumumab (GSK1841157), a clear colorless liquid, is supplied in a glass vial. Each vial contains 100mg of ofatumumab in 5mL.

Study Arm (s)

Experimental: ofatumumab

Japanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia

Intervention: Drug: ofatumumab

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2009

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00742144

Other Study ID Numbers ^ICMJE

OMB111148

Has Data Monitoring Committee

Not Provided

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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