NCT00742144

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2008

Completed
23 days until next milestone

Study Start

First participant enrolled

September 19, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2009

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

August 26, 2008

Last Update Submit

November 13, 2017

Conditions

Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular

Keywords

CD20 positiveChronic lymphocytic leukemiaFollicular lymphomaGSK1841157Japanese patientOfatumumab

Outcome Measures

Primary Outcomes (1)

  • tolerability

    eight weeks

Secondary Outcomes (1)

  • 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,

    nine months

Study Arms (1)

ofatumumab

EXPERIMENTAL

Japanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia

Drug: ofatumumab

Interventions

ofatumumabDRUG

Ofatumumab (GSK1841157), a clear colorless liquid, is supplied in a glass vial. Each vial contains 100mg of ofatumumab in 5mL.

ofatumumab

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GSK Investigational Site

Aichi, 466-8650, Japan

Location

GSK Investigational Site

Tokyo, 104-0045, Japan

Location

GSK Investigational Site

Tokyo, 135-8550, Japan

Location

Related Publications (1)

  • 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.

    PMID: 23456745BACKGROUND

Related Links

MeSH Terms

Conditions

LeukemiaBronchiolitis Obliterans SyndromeLymphomaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Follicular

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-Hodgkin

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2008

First Posted

August 27, 2008

Study Start

September 19, 2008

Primary Completion

November 18, 2009

Study Completion

November 18, 2009

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

JP(3)