NCT00066092

Brief Summary

This is a randomized, double-blind, multi-center study to assess the safety and effectiveness of using a single subcutaneous (under the skin) injection of pegfilgrastim or daily subcutaneous injections of Filgrastim to mobilize stem cells for autologous transplantation in patients with Hodgkin's or non-Hodgkin's lymphoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P50-P75 for phase_2 lymphoma

Timeline
Completed

Started Apr 2003

Shorter than P25 for phase_2 lymphoma

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

April 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

February 28, 2008

Status Verified

February 1, 2008

Enrollment Period

11 months

First QC Date

August 4, 2003

Last Update Submit

February 20, 2008

Conditions

LymphomaHodgkin's LymphomaNon-Hodgkin's LymphomaHematologyOncology

Keywords

PBPC transplantHodgkin's DiseaseNon-Hodgkin's LymphomaNHLmobilization

Outcome Measures

Primary Outcomes (1)

  • CD34+ collection during the collection phase

    10 days

Secondary Outcomes (1)

  • Time to ANC and platelet engraftment post-transplant

    100 days

Study Arms (3)

Pegfilgrastim 6 mg

EXPERIMENTAL

Pegfilgrastim 6 mg given once for PBPC mobilization

Drug: pegfilgrastim 6 mg

Pegfilgrastim 12 mg

EXPERIMENTAL

Pegfilgrastim 12 mg given once for PBPC mobilization

Drug: pegfilgrastim 12 mg

filgrastim

ACTIVE COMPARATOR

Filgrastim given daily for PBPC mobilization

Drug: filgrastim

Interventions

pegfilgrastim 12 mgDRUG

Pegfilgrastim 12 mg given once for PBPC mobilization

Pegfilgrastim 12 mg
filgrastimDRUG

Filgrastim given daily for PBPC mobilization

filgrastim
pegfilgrastim 6 mgDRUG

Pegfilgrastim 6 mg given once for PBPC mobilization

Pegfilgrastim 6 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Hodgkin's or non-Hodgkin's lymphoma patients suitable for an autologous PBPC transplant - No previous bone marrow or PBPC transplant

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

LymphomaHodgkin DiseaseLymphoma, Non-HodgkinNeoplasms

Interventions

pegfilgrastimFilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 4, 2003

First Posted

August 5, 2003

Study Start

April 1, 2003

Primary Completion

March 1, 2004

Study Completion

October 1, 2004

Last Updated

February 28, 2008

Record last verified: 2008-02