Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients

February 28, 2017 updated by: Kyowa Kirin Co., Ltd.

A Randomized Dose Finding Study of KRN125 (Pegfilgrastim) for the Treatment of Chemotherapy - Induced Neutropenia in Malignant Lymphoma

To assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with a single injection of KRN125 or multiple daily injections of filgrastim.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan
        • Tokai region
      • Fukuoka, Nagasaki, Japan
        • Kyusyu region
      • Gunma, Saitama, Tokyo, Kanagawa, Japan
        • Kanto region
      • Hokkaido, Japan
        • Hokkaido region
      • Kyoto, Mie, Shiga, Japan
        • Kinki region
      • Miyagi, Japan
        • Tohoku region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients diagnosed as malignant lymphoma
  • patients who were refractory to anthracycline or anthraquinone containing chemotherapy
  • patients who are going to receive ESHAP or CHASE treatment regimen
  • ECOG performance status =< 2
  • patients who have appropriate bone marrow, hepatic and renal functions
  • written informed consent

Exclusion Criteria:

  • double cancer
  • history of bone marrow transplantation or PBSCT
  • more than 2 prior chemotherapy regimens
  • primary hematologic disease such as myelodysplastic syndrome
  • previous radiotherapy within 4 weeks of enrollment
  • woman of childbearing potential who were either pregnant, breast feeding
  • patients who participated in other clinical trials within the last 4 weeks of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare the duration of severe neutropenia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Investigators

  • Study Chair: Tomomitsu Hotta, MD, Nagoya Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

August 14, 2006

First Submitted That Met QC Criteria

August 14, 2006

First Posted (Estimate)

August 15, 2006

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRN125/05-A04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neutropenia

Clinical Trials on pegfilgrastim

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe