Clinical trial NCT00742144: Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia
Official title: An Open-label Phase I Study of Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular
Keywords: CD20 positive
Chronic lymphocytic leukemia
Follicular lymphoma
GSK1841157
Japanese patient
Ofatumumab
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-08-27
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: tolerability
timeFrame: eight weeks
Secondary outcomes:
measure: 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,
timeFrame: nine months
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.