NCT00364468

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

6 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

Study Start

First participant enrolled

March 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

August 14, 2006

Last Update Submit

February 28, 2017

Conditions

Neutropenia

Keywords

pegfilgrastimneutropeniacancer patientslymphoma

Outcome Measures

Primary Outcomes (1)

  • To compare the duration of severe neutropenia

Interventions

pegfilgrastimDRUG

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Tokai region

Aichi, Japan

Location

Kyusyu region

Fukuoka, Nagasaki, Japan

Location

Kanto region

Gunma, Saitama, Tokyo, Kanagawa, Japan

Location

Hokkaido region

Hokkaido, Japan

Location

Kinki region

Kyoto, Mie, Shiga, Japan

Location

Tohoku region

Miyagi, Japan

Location

MeSH Terms

Conditions

NeutropeniaLymphoma

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Tomomitsu Hotta, MD

    Nagoya Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2006

First Posted

August 15, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 3, 2017

Record last verified: 2017-02

Locations

JP(6)