Pegfilgrastim vs. Filgrastim - Comparison of Mobilized Blood Stem Cells in Patients With Non Hodgkin-lymphoma

NCT00306111 | Completed Phase 2

• 1 other identifier: rpm_001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the ability of pegfilgrastim vs. filgrastim to mobilize peripheral blood stem cells in patients with Non Hodgkin-lymphoma in an intraindividual study

Conditions

Non-Hodgkin Lymphoma

Keywords

stem cell transplantation; stem cell mobilization; high-dose therapy

Outcome Measures

Primary Outcomes (1)

• Hematopoietic recovery after autologous stem cell transplantation

  Two cycles of conventional chemotherapy are given. Starting one day after the first cycle, filgrastim (5ug/kg bodyweight daily subcutaneously) is routinely administered to support neutrophil recovery. One day after the second cycle, a single dose of pegfilgrastim (6mg) is given to support neutrophil recovery and stem cell collection. Hematopoietic recovery (blood count) is monitored daily after high-dose therapy and autologous stem cell transplantation. Follow up assessments are performed 3-monthly for late graft failure

  1-3 weeks after transplantation, follow up every 3 months (up to 2 years)

Secondary Outcomes (1)

• Intraindividual comparison of quantity/quality of circulating stem cells

  before and during 3 weeks after conventional chemotherapy

Study Arms (1)

Pegfilgrastim

EXPERIMENTAL

Pegfilgrastim for stem cell mobilization (single arm)

Drug: pegfilgrastim

Interventions

pegfilgrastim DRUG

Single dose (6mg) one day after chemotherapy

Also known as: Neulasta(tm)

Pegfilgrastim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histological diagnosis of non-Hodgkin lymphoma
• planned high-dose therapy with autologous stem cell transplantation
• WHO performance status 0-2
• written consent

You may not qualify if:

• allergy against (peg)filgrastim
• life expectancy \<3 months
• other malignant diseases within the last 5 years
• cardial insufficiency (\>= New York Heart Association II°)
• uncontrolled infection
• pregnancy, lactation
• central nervous system lymphoma
• Karnofsky score \<70%

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Dept. of Medicine 2, University of Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Robert Mohle, MD

  University of Tuebingen, Dept. of Medicine 2

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oberarzt

Study Record Dates

• First Submitted: March 20, 2006
• First Posted: March 22, 2006
• Study Start: January 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2011
• Last Updated: May 29, 2014

Record last verified: 2012-12

Locations

DE (1)