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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00742144 |
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 |
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Follicular Lymphoma Chronic Lymphocytic Leukemia |
Drug: Ofatumumab injection vial |
Phase I |
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 |
Estimated Enrollment: | 12 |
Study Start Date: | September 2008 |
Ages Eligible for Study: | 20 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
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 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
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 |
Ofatumumab GSK1841157 Follicular lymphoma |
Chronic lymphocytic leukemia Japanese patient CD20 positive |
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 |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |