Last updated: 11/04/2018 10:06:25

Ofatumumab in Japanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia

GSK study ID
OMB111148
See study documents
Clinicaltrials.gov ID
NCT00742144
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An open-label phase I study of Ofatumumab in Japanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

tolerability

Timeframe: eight weeks

Secondary outcomes:

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

Interventions:
  • Drug: ofatumumab
    • Enrollment:
    6
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Ogura M, Hatake K, Tobinai K, Uchida T, Suzuki T, Terui Y, Yokoyama M, Maruyama D, Mori M, Katsura K, Jewell R, 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;43(5):466-475.
    Ogura M, Hatake K, Tobinai K, Uchida T, Suzuki T, Terui Y, Yokoyama M, Maruyama D, Mori M, Katsura K, Jewell R, 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;43(5):466-475
    Medical condition
    Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular
    Product
    ofatumumab
    Collaborators
    Not applicable
    Study date(s)
    September 2008 to November 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    20 - 79 years
    Accepts healthy volunteers
    No
    • INCLUSION CRITERIA:
    • Signed Informed Consent.
    Inclusion and exclusion criteria
    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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Tokyo, Japan, 135-8550
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tokyo, Japan, 104-0045
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Aichi, Japan, 466-8650
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2009-18-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study OMB111148 can be found on the GSK Clinical Study Register.
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