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

Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742144
• Other study ID #: OMB111148
• Status: Completed
• Phase: Phase 1
• First received: August 26, 2008
• Last updated: November 13, 2017
• Start date: September 19, 2008
• Est. completion date: November 18, 2009

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 18, 2009
• Est. primary completion date: November 18, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Follicular

Intervention

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

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tolerability		eight weeks
Secondary	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

External Links

•   Results for study OMB111148 can be found on the GSK Clinical Study Register.