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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular

Treatments

Drug: ofatumumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00742144

OMB111148

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

20 to 79 years old

Volunteers

No 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