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Treatment for Subjects With Non-Hodgkin's Lymphoma
This study has been completed.
First Received: June 30, 2005   Last Updated: January 22, 2009   History of Changes
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00117897
  Purpose

This multicenter, open-label, randomized, parallel study was designed to evaluate whether a single fixed-dose subcutaneous (SC) administration of pegfilgrastim or daily administration of Filgrastim for absolute neutrophil count (ANC) support would assist in allowing the planned dose-on-time (PDOT) of cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) chemotherapy with Rituximab every 14 days in subjects with aggressive B-cell Non-Hodgkin's Lymphoma by reducing the duration of neutropenia and incidence of febrile neutropenia.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: pegfilgrastim
Drug: Filgrastim
Phase II

MedlinePlus related topics: Lymphoma
Drug Information available for: Filgrastim Pegfilgrastim
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
Official Title: An Open-Label, Randomized, Parallel, Phase II Study of CHOP Chemotherapy and Rituximab Administered Every 14 Days, With Pegfilgrastim or Filgrastim Support, for the Treatment of Subjects With Non-Hodgkin's Lymphoma

Further study details as provided by Amgen:

Primary Outcome Measures:
  • The primary objective was to provide preliminary information on the ability of pegfilgrastim or Filgrastim to support planned dose on time (PDOT) application of CHOP chemotherapy with Rituximab given every 14 days, to subjects with NHL.

Secondary Outcome Measures:
  • The proportion of chemotherapy cycles given at the PDOT in both arms.
  • Response rates (complete response and partial response) in both arms
  • The safety profile in cycles 1-6
  • Subject self-reported outcomes

Study Start Date: July 2002
Estimated Study Completion Date: February 2004
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: - Histologically proven aggressive B-cell Non-Hodgkin's lymphoma (IWF classification D-H) with: - Bone marrow involvement less than 30% demonstrated by aspiration - Age-adjusted International Prognostic Index (IPI) 0-2 - Measurable or evaluable disease - ECOG performance status 0-2

  • Life expectancy greater than or equal to 12 weeks - Absolute neutrophil count greater than 1.5 x 109/L - Platelet count greater than 100 x 109/L - Adequate organ function (serum creatinine less than or equal to 2.0 mg/dL, SGOT/AST and SGPT/ALT less than 3 x the upper limit of normal, hemoglobin greater than or equal to 10g/dL and total serum bilirubin less than or equal to 1.5 mg/dL) - Left Ventricular Ejection Fraction (LVEF) greater than or equal to 50% at rest by MUGA or echocardiogram - Previously untreated with chemotherapy or radiotherapy - Before any study specific procedure or before study medication was administered, the subject was to give written informed consent for participation in the study Exclusion Criteria: - Burkitt's or B-lymphoblastic lymphoma - CNS involvement - Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, antiviral) within 72 hours of chemotherapy - Use of anti-hypertensives within 12 hours of start of chemotherapy - Known HIV infection - Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukaemia)
  • Prior malignancy within the last 5 years, with the exception of surgically cured basal cell carcinoma, squamous skin cell carcinoma, or in situ carcinoma of the cervix - Prior bone marrow or stem cell transplantation - History of impaired cardiac status, e.g. severe heart disease,cardiomyopathy, or congestive heart failure - Major surgery within 2 weeks prior to randomization - Subject is evidently pregnant (e.g., positive HCG test unless termination is proven) or is breast feeding - Subject is not using adequate contraceptive precautions - Known hypersensitivity to E coli-derived products (e.g., Filgrastim,HUMULIN® Insulin, L-Asparaginase, HUMATROPE® Growth Hormone, INTRON A®) - Any psychiatric, addictive or other kind of disorder which compromised the ability of the subject to give written informed consent and/or to comply with study protocol procedures - Prior exposure to pegfilgrastim - Subject is currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial(s) or is receiving other investigational agent(s) - Subject has previously entered this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117897

Locations
Austria
Research Site
Wien, Austria
Research Site
Linz, Austria
France
Research Site
Le Chesnay, France
Research Site
Besançon, France
Spain
Research Site
Barcelona, Spain
Research Site
Badalona, Spain
Research Site
Murcia, Spain
Research Site
Salamanca, Spain
Research Site
Madrid, Spain
Research Site
Santander, Spain
Research Site
L'Hospitalet de Llobregat, Spain
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20010157
Study First Received: June 30, 2005
Last Updated: January 22, 2009
ClinicalTrials.gov Identifier: NCT00117897     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Amgen:
non-Hodgkin's lymphoma
R-CHOP-14
pegfilgrastim
neutropenia, clinical trial
haematopoietic growth factor

Study placed in the following topic categories:
Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Neutropenia
Immunoproliferative Disorders
Rituximab
Mitogens
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009