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

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.

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Key information

Conditions

Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Disease Disease Attributes Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lung Diseases Lung Diseases, Obstructive Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Aichi, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ofatumumab

Drug

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

Primary outcomes

tolerability

Time frame: eight weeks

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Aug 27, 2008
Registry last updated: Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed