Status:
COMPLETED
Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia
Lead Sponsor:
GlaxoSmithKline
Conditions:
Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular
Eligibility:
All Genders
20-79 years
Phase:
PHASE1
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. sub...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 19 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00742144
Start Date
September 19 2008
End Date
November 18 2009
Last Update
November 17 2017
Active Locations (3)
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1
GSK Investigational Site
Aichi, Japan, 466-8650
2
GSK Investigational Site
Tokyo, Japan, 104-0045
3
GSK Investigational Site
Tokyo, Japan, 135-8550