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Pegfilgrastim Administered on the Same Day as Chemotherapy in Non-Hodgkin's Lymphoma

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
pegfilgrastim
pegfilgrastim
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Oncology, NHL, Mantle cell, Diffuse large B-cell, Chemotherapy, RCHOP, Neulasta®, Neutropenia, Pegfilgrastim, Amgen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Arm A

    Arm B

    Arm Description

    Pegfilgrastim

    Pegfilgrastim

    Outcomes

    Primary Outcome Measures

    Reduce the duration of neutropenia and incidence of febrile neutropenia.

    Secondary Outcome Measures

    On the same day as chemotherapy as measured by the incidence of hematologic and non-hematologic toxicities, the number of subjects who received planned doses of chemotherapy on time and response rates.

    Full Information

    First Posted
    June 21, 2005
    Last Updated
    August 27, 2013
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00115193
    Brief Title
    Pegfilgrastim Administered on the Same Day as Chemotherapy in Non-Hodgkin's Lymphoma
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2003 (undefined)
    Primary Completion Date
    August 2005 (Actual)
    Study Completion Date
    August 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia.
    Detailed Description
    This was a multicenter, double-blind, randomized, phase 2 study of pegfilgrastim given either the same day as or the day after a chemotherapy regimen consisting of cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP). Chemotherapy was administered every 21 days for up to 6 cycles in subjects with aggressive non-Hodgkin's lymphoma (NHL; mantle cell or diffuse large B-cell lymphoma). Subjects were administered R-CHOP on day 1 of each cycle. All subjects were randomized to 1 of 2 treatment arms: arm A subjects were administered pegfilgrastim 6 mg on day 1 of each cycle (within 4 hours of chemotherapy completion); arm B subjects were administered pegfilgrastim 6 mg on day 2 of each cycle (at least 24 hours after chemotherapy completion). All subjects were administered placebo on the day they did not receive pegfilgrastim. A total of 77 subjects were enrolled at 24 centers across the US. Protocol treatment duration for subjects was up to 18 weeks (6 three-week cycles).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Hodgkin's Lymphoma
    Keywords
    Oncology, NHL, Mantle cell, Diffuse large B-cell, Chemotherapy, RCHOP, Neulasta®, Neutropenia, Pegfilgrastim, Amgen

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    77 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A
    Arm Type
    Active Comparator
    Arm Description
    Pegfilgrastim
    Arm Title
    Arm B
    Arm Type
    Active Comparator
    Arm Description
    Pegfilgrastim
    Intervention Type
    Drug
    Intervention Name(s)
    pegfilgrastim
    Intervention Description
    pegfilgrastim 6 mg on day 1 of each cycle (within 4 hours of chemotherapy completion)
    Intervention Type
    Drug
    Intervention Name(s)
    pegfilgrastim
    Intervention Description
    pegfilgrastim 6 mg on day 2 of each cycle (at least 24 hours after chemotherapy completion)
    Primary Outcome Measure Information:
    Title
    Reduce the duration of neutropenia and incidence of febrile neutropenia.
    Time Frame
    The primary outcome will be evaluated at the end of the study.
    Secondary Outcome Measure Information:
    Title
    On the same day as chemotherapy as measured by the incidence of hematologic and non-hematologic toxicities, the number of subjects who received planned doses of chemotherapy on time and response rates.
    Time Frame
    The secondary outcome will be evaluated at the end of the study.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
    Description
    Notice regarding posted summaries of trial results
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_11_GCSFSD01_20020134.pdf
    Description
    To access clinical trial results information click on this link
    URL
    http://www.neulasta.com/
    Description
    FDA-approved Drug Labeling

    Learn more about this trial

    Pegfilgrastim Administered on the Same Day as Chemotherapy in Non-Hodgkin's Lymphoma

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