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An Open-label Phase I Study of Ofatumumab (GSK1841157) in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia


Phase 1
20 Years
79 Years
Not Enrolling
Both
Follicular Lymphoma, Chronic Lymphocytic Leukemia, Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular

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Trial Information

An Open-label Phase I Study of Ofatumumab (GSK1841157) in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

tolerability

Outcome Time Frame:

eight weeks

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

OMB111148

NCT ID:

NCT00742144

Start Date:

September 2008

Completion Date:

November 2009

Related Keywords:

  • Follicular Lymphoma
  • Chronic Lymphocytic Leukemia
  • Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular
  • CD20 positive
  • Chronic lymphocytic leukemia
  • Follicular lymphoma
  • GSK1841157
  • Japanese patient
  • Ofatumumab
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Follicular

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