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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00742144
First received: August 26, 2008
Last updated: May 31, 2012
Last verified: February 2011

August 26, 2008
May 31, 2012
September 2008
November 2009   (final data collection date for primary outcome measure)
tolerability [ Time Frame: eight weeks ]
tolerability
Complete list of historical versions of study NCT00742144 on ClinicalTrials.gov Archive Site
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, [ Time Frame: nine months ]
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,
Not Provided
Not Provided
 
Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia
An Open-label Phase I Study of Ofatumumab (GSK1841157) in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Follicular Lymphoma
  • Chronic Lymphocytic Leukemia
  • Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular
Drug: ofatumumab
Ofatumumab (GSK1841157), a clear colorless liquid, is supplied in a glass vial. Each vial contains 100mg of ofatumumab in 5mL.
Experimental: ofatumumab
Japanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia
Intervention: Drug: ofatumumab
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00742144
OMB111148
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP