Pegfilgrastim PBPC Mobilization Study

Lymphoma Clinical Trial

Official title:

Randomized, Double-Blind Study of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Pegfilgrastim or Filgrastim for Autologous Transplantation in Subjects With Hodgkin's or Non-Hodgkin's Lymphoma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066092
• Other study ID #: 20020112
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2003
• Last updated: February 20, 2008
• Start date: April 2003
• Est. completion date: October 2004

Study information

• Verified date: February 2008
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Other known NCT identifiers

• NCT00060229

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• Hodgkin's or non-Hodgkin's lymphoma patients suitable for an autologous PBPC transplant - No previous bone marrow or PBPC transplant

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematology
• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma
• Oncology

Intervention

Drug:
• pegfilgrastim 12 mg
Pegfilgrastim 12 mg given once for PBPC mobilization
• filgrastim
Filgrastim given daily for PBPC mobilization
• pegfilgrastim 6 mg
Pegfilgrastim 6 mg given once for PBPC mobilization

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD34+ collection during the collection phase		10 days	No
Secondary	Time to ANC and platelet engraftment post-transplant		100 days	Yes

External Links

•   AmgenTrials clinical trials website