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Pegfilgrastim PBPC Mobilization Study

NCT ID: NCT00066092

Last Updated: 2008-02-28

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

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-10-31

Brief Summary

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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.

Detailed Description

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This is a research study for Hodgkin's Disease and Non-Hodgkin's Lymphoma (NHL) patients who will receive high-dose chemotherapy with autologous peripheral blood stem cell (PBSC or PBPC) transplant. The chemotherapy doses are high enough to severely suppress the bone marrow (where blood cells are made) and cause very low blood counts. A collection of stem cells (very young blood cells) followed by reinfusion to restore blood counts will be done to stimulate recovery of your blood counts. This procedure is called leukapheresis. Giving growth factors to patients is a method to increase the number of PBPC that can be collected during leukapheresis. This process of giving growth factors to patients is called mobilization (moving cells from the bone marrow to the peripheral blood where they can be collected). The purpose of this study is to determine if pegfilgrastim, an investigational drug, can safely and effectively mobilize stem cells. Filgrastim (also known as NEUPOGEN® or G-CSF) is approved by the FDA for stem cell mobilization. Pegfilgrastim is a modified version of Filgrastim that is longer acting.

Conditions

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Lymphoma Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Hematology Oncology

Keywords

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PBPC transplant Hodgkin's Disease Non-Hodgkin's Lymphoma NHL mobilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pegfilgrastim 6 mg

Pegfilgrastim 6 mg given once for PBPC mobilization

Group Type EXPERIMENTAL

pegfilgrastim 6 mg

Intervention Type DRUG

Pegfilgrastim 6 mg given once for PBPC mobilization

Pegfilgrastim 12 mg

Pegfilgrastim 12 mg given once for PBPC mobilization

Group Type EXPERIMENTAL

pegfilgrastim 12 mg

Intervention Type DRUG

Pegfilgrastim 12 mg given once for PBPC mobilization

filgrastim

Filgrastim given daily for PBPC mobilization

Group Type ACTIVE_COMPARATOR

filgrastim

Intervention Type DRUG

Filgrastim given daily for PBPC mobilization

Interventions

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pegfilgrastim 12 mg

Pegfilgrastim 12 mg given once for PBPC mobilization

Intervention Type DRUG

filgrastim

Filgrastim given daily for PBPC mobilization

Intervention Type DRUG

pegfilgrastim 6 mg

Pegfilgrastim 6 mg given once for PBPC mobilization

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hodgkin's or non-Hodgkin's lymphoma patients suitable for an autologous PBPC transplant - No previous bone marrow or PBPC transplant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Countries

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United States

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf

Notice regarding posted summaries of trial results

http://download.veritasmedicine.com/REGFILES/amgen/20020112.pdf

To access clinical trial results information click on this link

Other Identifiers

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20020112

Identifier Type: -

Identifier Source: org_study_id

NCT00060229

Identifier Type: -

Identifier Source: nct_alias