- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00742144
Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia
November 13, 2017 updated by: GlaxoSmithKline
An Open-label Phase I Study of 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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Aichi, Japan, 466-8650
- GSK Investigational Site
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Tokyo, Japan, 104-0045
- GSK Investigational Site
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Tokyo, Japan, 135-8550
- GSK Investigational Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ofatumumab
Japanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia
|
Ofatumumab (GSK1841157), a clear colorless liquid, is supplied in a glass vial.
Each vial contains 100mg of ofatumumab in 5mL.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tolerability
Time Frame: eight weeks
|
eight weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
nine months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 19, 2008
Primary Completion (Actual)
November 18, 2009
Study Completion (Actual)
November 18, 2009
Study Registration Dates
First Submitted
August 26, 2008
First Submitted That Met QC Criteria
August 26, 2008
First Posted (Estimate)
August 27, 2008
Study Record Updates
Last Update Posted (Actual)
November 17, 2017
Last Update Submitted That Met QC Criteria
November 13, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Leukemia, B-Cell
- Lymphoma
- Lymphoma, Follicular
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Antineoplastic Agents
- Ofatumumab
Other Study ID Numbers
- OMB111148
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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