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

Primary Purpose

Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
ofatumumab
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular focused on measuring CD20 positive, Chronic lymphocytic leukemia, Follicular lymphoma, GSK1841157, Japanese patient, Ofatumumab

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ofatumumab

Arm Description

Japanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia

Outcomes

Primary Outcome Measures

tolerability

Secondary Outcome Measures

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,

Full Information

First Posted
August 26, 2008
Last Updated
November 13, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00742144
Brief Title
Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia
Official Title
An Open-label Phase I Study of Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 19, 2008 (Actual)
Primary Completion Date
November 18, 2009 (Actual)
Study Completion Date
November 18, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular
Keywords
CD20 positive, Chronic lymphocytic leukemia, Follicular lymphoma, GSK1841157, Japanese patient, Ofatumumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ofatumumab
Arm Type
Experimental
Arm Description
Japanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia
Intervention Type
Drug
Intervention Name(s)
ofatumumab
Intervention Description
Ofatumumab (GSK1841157), a clear colorless liquid, is supplied in a glass vial. Each vial contains 100mg of ofatumumab in 5mL.
Primary Outcome Measure Information:
Title
tolerability
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Aichi
ZIP/Postal Code
466-8650
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
23456745
Citation
Ogura M, Hatake K, Tobinai K, Uchida T, Suzuki T, Terui Y, Yokoyama M, Maruyama D, Mori M, Jewell RC, Katsura K, Hotta T. Phase I study of ofatumumab, a human anti-CD20 antibody, in Japanese patients with relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma. Jpn J Clin Oncol. 2013 May;43(5):466-75. doi: 10.1093/jjco/hyt022. Epub 2013 Feb 28.
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Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia

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