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

NCT ID: NCT00742144

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-19

Study Completion Date

2009-11-18

Brief Summary

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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.

Detailed Description

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Conditions

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Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular

Keywords

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CD20 positive Chronic lymphocytic leukemia Follicular lymphoma GSK1841157 Japanese patient Ofatumumab

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ofatumumab

Japanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia

Group Type EXPERIMENTAL

ofatumumab

Intervention Type DRUG

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

Interventions

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ofatumumab

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Aichi, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type BACKGROUND
PMID: 23456745 (View on PubMed)

Other Identifiers

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OMB111148

Identifier Type: -

Identifier Source: org_study_id