GP2013 in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma

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

2013-05-31

Study Completion Date

2014-08-31

Brief Summary

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The purpose of this study is to evaluate safety and pharmacokinetic of GP2013 in Japanese patients with CD20 positive low tumor burden indolent B-cell NHL under weekly dosing schedule.

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Detailed Description

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Conditions

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Indolent B-cell Non-Hodgkin's Lymphoma

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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GP2013

Group Type EXPERIMENTAL

GP2013

Intervention Type DRUG

GP2013

Interventions

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GP2013

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient with CD20 positive low tumor burden indolent B-cell non- Hodgkin's lymphoma.
* Patient with at least one measurable lesion.
* Patient with ECOG performance status 0 or 1.

Exclusion Criteria

* Patient who has received radiotherapy within the last 28 days prior to administration, or are not recovered from previous radiotherapy.
* Patient who has received immunotherapy, chemotherapy, antibodies and experimental treatment within the last 28 days prior to administration, or are not recovered from previous therapy.
* Patient who has mAb therapy other than rituximab as prior line of therapy.
* Patient with evidence of any uncontrolled, acute or chronic active infection (viral, bacterial or fungal).
* Patient with any other malignancy within 5 years prior to date of screening, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or nonmelanomatous skin cancer.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No