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

Study Overview
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Brief Summary
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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.

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

Conditions
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Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular

Intervention / Treatment
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* Drug: ofatumumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ofatumumab<br>Japanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia | Drug: ofatumumab<br>* Ofatumumab (GSK1841157), a clear colorless liquid, is supplied in a glass vial. Each vial contains 100mg of ofatumumab in 5mL.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tolerability |  | eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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, |  | nine months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CD20 positive, Chronic lymphocytic leukemia, Follicular lymphoma, GSK1841157, Japanese patient, Ofatumumab