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A Study of Peripheral Blood Progenitor Cell (PBPC) Mobilisation by Chemotherapy With Pegfilgrastim or Filgrastim in Subjects With Non-Hodgkin's Lymphoma

This study has been completed.
Information provided by:
Amgen Identifier:
First received: June 30, 2005
Last updated: May 15, 2008
Last verified: May 2008
The purpose of this study is to evaluate the ability of two different fixed doses of pegfilgrastim (6mg and 12mg) and a by-weight dose of filgrastim (5ug/kg/day) for the mobilisation and collection of PBPCs for autologous transplantation after chemotherapy.

Condition Intervention Phase
Non-Hodgkin's Lymphoma Drug: pegfilgrastim Drug: filgrastim Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, Multi-Centre, Double-Blind Study of Peripheral Blood Progenitor Cell (PBPC) Mobilisation by Chemotherapy With Pegfilgrastim or Filgrastim for Autologous Transplantation in Subjects With Non-Hodgkin's Lymphoma

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Adequate collection of PBPC's to enable transplant following high dose chemotherapy

Secondary Outcome Measures:
  • Time to engraftment post-transplant


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Inclusion Criteria: - Subjects with non-Hodgkin's lymphoma (NHL) who are considered to be suitable candidates for autologous PBPC transplantation per institution guidelines - ECOG 0-2 inclusive - ANC greater than 1.5 x 10^9/L; PLT greater than 100 x 10^9/L Exclusion Criteria: - More than one line (regimen) of previous chemotherapy treatment and more than 2 cycles of any premobilisation salvage chemotherapy prior to enrolment. Patients were also to be excluded from the study if they had received any salvage chemotherapy containing the following agents: procarbazine, nitrogen mustard, nitrosoureas (including BCNU), melphalan and fludarabine. - Previous bone marrow or PBPC transplant - Greater than 20% bone marrow involvement of the disease at time of screening, as demonstrated by biopsy - Prior total nodal irradiation or any radiotherapy in the past 4 weeks - Serum creatinine greater than 1.5 x upper limit of institutional normal range - Total serum bilirubin greater than 2 x upper limit of institutional normal range - Current diagnosis of splenomegaly not related to lymphoma - History of prior malignancy, except for lymphoma, curatively treated basal cell carcinoma, squamous cell carcinoma, in-situ cervical carcinoma or a surgically cured malignancy - Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukaemia) - Significant non-malignant disease, including documented HIV infection, uncontrolled hypertension (diastolic blood pressure greater than 115 mmHg), unstable angina, congestive heart failure (greater than NY Heart Association Class II), poorly controlled diabetes, coronary angioplasty within 6 months, uncontrolled atrial or ventricular cardiac arrhythmias, or active hepatitis C - Haematopoietic growth factors administered within 1 week of study entry. If growth factor support was given during previous chemotherapy cycles, WBC less than 15.0 x 10^9/L was required at enrolment - Treatment with Interferon® during the last 3 months - Known hypersensitivity to E. coli-derived pharmaceutical products (e.g., filgrastim, HUMULIN® insulin, L-asparaginase) - Subject had previously been randomised into this study
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Please refer to this study by its identifier: NCT00117455

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00117455     History of Changes
Other Study ID Numbers: 20020113
Study First Received: June 30, 2005
Last Updated: May 15, 2008

Keywords provided by Amgen:
PBPC transplant

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017