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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00742144

Enrollment

Registered

2008-08-27

Start date

2008-09-19

Completion date

2009-11-18

Last updated

2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular

Keywords

CD20 positive, Chronic lymphocytic leukemia, Follicular lymphoma, GSK1841157, Japanese patient, Ofatumumab

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.

Interventions

DRUGofatumumab

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

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

Design outcomes

Primary

Measure	Time frame
tolerability	eight weeks

Secondary

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,	nine months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026