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A Multicenter, Double-Blind, Randomized Study of Pegfilgrastim Administered on the Same Day or the Next Day of R-Chop Chemotherapy in Subjects With Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

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Trial Information

A Multicenter, Double-Blind, Randomized Study of Pegfilgrastim Administered on the Same Day or the Next Day of R-Chop Chemotherapy in Subjects With Non-Hodgkin's Lymphoma


Inclusion Criteria:

- Histologically proven mantle cell lymphoma or histologically proven
diffuse large B-cell non-Hodgkin's lymphoma (NHL) according to the REAL classification -
Measurable and/or evaluable disease - Previously untreated patients Exclusion Criteria: -
Burkitt's or B-lymphoblastic lymphoma - Central nervous system (CNS) involvement - Active
infection requiring treatment with systemic anti-infectives within 72 hours of
chemotherapy - Prior malignancy within the last 5 years - T-cell lymphoma or history of
indolent lymphoma - Prior bone marrow or stem cell transplantation - Known sensitivity to
E. coli derived drug products

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Reduce the duration of neutropenia and incidence of febrile neutropenia.

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20020134

NCT ID:

NCT00115193

Start Date:

February 2003

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Oncology
  • NHL
  • Mantle cell
  • Diffuse large B-cell
  • Chemotherapy
  • RCHOP
  • Neulasta┬«
  • Neutropenia
  • Pegfilgrastim
  • Amgen
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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