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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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

20010157

NCT ID:

NCT00117897

Start Date:

July 2002

Completion Date:

February 2004

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • non-Hodgkin's lymphoma
  • R-CHOP-14
  • pegfilgrastim
  • neutropenia, clinical trial
  • haematopoietic growth factor
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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