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

Primary Purpose

Neutropenia

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
pegfilgrastim
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neutropenia focused on measuring pegfilgrastim, neutropenia, cancer patients, lymphoma

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tokai region
  • Kyusyu region
  • Kanto region
  • Hokkaido region
  • Kinki region
  • Tohoku region

Outcomes

Primary Outcome Measures

To compare the duration of severe neutropenia

Secondary Outcome Measures

Full Information

First Posted
August 14, 2006
Last Updated
February 28, 2017
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00364468
Brief Title
Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients
Official Title
A Randomized Dose Finding Study of KRN125 (Pegfilgrastim) for the Treatment of Chemotherapy - Induced Neutropenia in Malignant Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia
Keywords
pegfilgrastim, neutropenia, cancer patients, lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pegfilgrastim
Primary Outcome Measure Information:
Title
To compare the duration of severe neutropenia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomomitsu Hotta, MD
Organizational Affiliation
Nagoya Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Tokai region
City
Aichi
Country
Japan
Facility Name
Kyusyu region
City
Fukuoka, Nagasaki
Country
Japan
Facility Name
Kanto region
City
Gunma, Saitama, Tokyo, Kanagawa
Country
Japan
Facility Name
Hokkaido region
City
Hokkaido
Country
Japan
Facility Name
Kinki region
City
Kyoto, Mie, Shiga
Country
Japan
Facility Name
Tohoku region
City
Miyagi
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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