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Pegfilgrastim and Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Aggressive B-Cell Non-Hodgkin Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
pegfilgrastim
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
Sponsored by
Universität des Saarlandes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage III grade 3 follicular lymphoma, stage I adult lymphoblastic lymphoma, stage III adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, contiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, anaplastic large cell lymphoma, stage III adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage III adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, stage III mantle cell lymphoma, stage I mantle cell lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage I adult Burkitt lymphoma, contiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult Burkitt lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma, stage I marginal zone lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II marginal zone lymphoma

Eligibility Criteria

61 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Diagnosis of CD20-positive B-cell non-Hodgkin lymphoma (NHL)

    • Confirmed by an excisional biopsy of a lymph node or by a sufficiently extensive biopsy of an extranodal involvement (if there is no lymph node involvement)
    • Results of the immunohistological analysis of expression of the CD20 antigen by lymphoma cells must be obtained

  • Aggressive disease, including any of the following B-cell NHL

    • Stage III follicular lymphoma
    • Stage III follicular lymphoma and diffuse B-cell lymphoma
    • Lymphoblastic precursor B-cell lymphoma

    • Diffuse large B-cell lymphoma, including any of the following subtypes:

      • Centroblastic
      • Immunoblastic
      • Plasmablastic
      • Anaplastic large cell
      • T-cell rich B-cell lymphoma
      • Primary effusion lymphoma
      • Intravasal B-cell lymphoma
      • Primary mediastinal B-cell lymphoma
    • Mantle zone lymphoma
    • Burkitt or Burkitt-like lymphoma
    • Aggressive marginal zone lymphoma (monocytoid)

  • All risk group allowed

    • Age adjusted IPI 0-3
  • Previously untreated disease

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • No other serious concurrent diseases

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Arm I (without rituximab)

    Arm II (with rituximab)

    Arm Description

    Patients receive pegfilgrastim subcutaneously (SC) on day 2 or 4 and CHOP comprising cyclophosphamide IV, doxorubicin IV, vincristine IV on day 1, and oral prednisone on days 1-5. Treatment repeats every 2 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity.

    Patients receive pegfilgrastim and CHOP for up to 6-8 courses as in arm I. They also receive rituximab (administered 2 hours before beginning CHOP) on day 1. Treatment with rituximab repeats every 2 weeks for up to 8 courses.

    Outcomes

    Primary Outcome Measures

    comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia
    median of two measurements of hemoglobin, leukocyte and platelet counts per chemotherapy cycle per Patient in correlation with median pegfilgrastim serum levels at day 1 of the next chemotherapy cycle
    comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia
    rates and grades of leukocytopenias and infections according to NCI-CTC criteria (version 2)

    Secondary Outcome Measures

    Adherence to therapy regimens
    the median overall treatment duration
    Antitumor effectivity
    progression-free survival
    Disease-free survival
    period of disease-free survival

    Full Information

    First Posted
    July 31, 2008
    Last Updated
    July 2, 2021
    Sponsor
    Universität des Saarlandes
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00726700
    Brief Title
    Pegfilgrastim and Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Aggressive B-Cell Non-Hodgkin Lymphoma
    Official Title
    Randomized Phase II Study About the Application of Pegfilgrastim (Neulasta) at Day 2 or Day 4 Within the Treatment in Patients With Aggressive Non-Hodgkin's Lymphoma Aged 61 to 80 Years With 6 or 8 Cycles of Chemotherapy With CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) at 14-day Intervals (CHOP-14), Both With or Without the Monoclonal Anti-CD20 Antibody Rituximab
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2004 (undefined)
    Primary Completion Date
    February 2012 (Actual)
    Study Completion Date
    February 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universität des Saarlandes

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, and vincristine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. It is not yet known whether combination chemotherapy and pegfilgrastim is more effective when given with or without rituximab in treating non-Hodgkin lymphoma. PURPOSE: This phase II trial is studying the side effects of giving pegfilgrastim and combination chemotherapy together with or without rituximab and to see how well it works in treating older patients with aggressive B-cell non-Hodgkin lymphoma.
    Detailed Description
    OBJECTIVES: Determine the side effects of pegfilgrastim and cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) with or without rituximab in older patients with aggressive B-cell non-Hodgkin lymphoma. Determine adherence to therapy regimens in these patients. Determine antitumor effectivity of immunochemotherapy. OUTLINE: This is a multicenter study. All patients receive prephase treatment comprising vincristine on day -6 and prednisone on days -6 to 0. Patients are then randomized to 1 of 2 treatment arms. Arm I (without rituximab): Patients receive pegfilgrastim subcutaneously (SC) on day 2 or 4 and CHOP comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, and oral prednisone on days 1-5. Treatment repeats every 2 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity. Arm II (with rituximab): Patients receive pegfilgrastim and CHOP for up to 6-8 courses as in arm I. They also receive rituximab (administered 2 hours before beginning CHOP) on day 1. Treatment with rituximab repeats every 2 weeks for up to 8 courses. Patients with bulky disease or extranodal disease also undergo radiotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma
    Keywords
    stage III grade 3 follicular lymphoma, stage I adult lymphoblastic lymphoma, stage III adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, contiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, anaplastic large cell lymphoma, stage III adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage III adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, stage III mantle cell lymphoma, stage I mantle cell lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage I adult Burkitt lymphoma, contiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult Burkitt lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma, stage I marginal zone lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II marginal zone lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Allocation
    Randomized
    Enrollment
    109 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm I (without rituximab)
    Arm Type
    Active Comparator
    Arm Description
    Patients receive pegfilgrastim subcutaneously (SC) on day 2 or 4 and CHOP comprising cyclophosphamide IV, doxorubicin IV, vincristine IV on day 1, and oral prednisone on days 1-5. Treatment repeats every 2 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity.
    Arm Title
    Arm II (with rituximab)
    Arm Type
    Experimental
    Arm Description
    Patients receive pegfilgrastim and CHOP for up to 6-8 courses as in arm I. They also receive rituximab (administered 2 hours before beginning CHOP) on day 1. Treatment with rituximab repeats every 2 weeks for up to 8 courses.
    Intervention Type
    Biological
    Intervention Name(s)
    pegfilgrastim
    Intervention Description
    Given subcutaneously
    Intervention Type
    Biological
    Intervention Name(s)
    rituximab
    Intervention Description
    Given IV
    Intervention Type
    Drug
    Intervention Name(s)
    cyclophosphamide
    Intervention Description
    Given IV
    Intervention Type
    Drug
    Intervention Name(s)
    doxorubicin hydrochloride
    Intervention Description
    Given IV
    Intervention Type
    Drug
    Intervention Name(s)
    prednisone
    Intervention Description
    Given orally
    Intervention Type
    Drug
    Intervention Name(s)
    vincristine sulfate
    Intervention Description
    Given IV
    Primary Outcome Measure Information:
    Title
    comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia
    Description
    median of two measurements of hemoglobin, leukocyte and platelet counts per chemotherapy cycle per Patient in correlation with median pegfilgrastim serum levels at day 1 of the next chemotherapy cycle
    Time Frame
    through chemotherapy administration (up to 112 days respectively)
    Title
    comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia
    Description
    rates and grades of leukocytopenias and infections according to NCI-CTC criteria (version 2)
    Time Frame
    through chemotherapy administration (up to 112 days respectively)
    Secondary Outcome Measure Information:
    Title
    Adherence to therapy regimens
    Description
    the median overall treatment duration
    Time Frame
    through chemotherapy administration (up to 112 days respectively)
    Title
    Antitumor effectivity
    Description
    progression-free survival
    Time Frame
    median time of observation up to 3 years
    Title
    Disease-free survival
    Description
    period of disease-free survival
    Time Frame
    median time of observation up to 3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    61 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Diagnosis of CD20-positive B-cell non-Hodgkin lymphoma (NHL) Confirmed by an excisional biopsy of a lymph node or by a sufficiently extensive biopsy of an extranodal involvement (if there is no lymph node involvement) Results of the immunohistological analysis of expression of the CD20 antigen by lymphoma cells must be obtained Aggressive disease, including any of the following B-cell NHL Stage III follicular lymphoma Stage III follicular lymphoma and diffuse B-cell lymphoma Lymphoblastic precursor B-cell lymphoma Diffuse large B-cell lymphoma, including any of the following subtypes: Centroblastic Immunoblastic Plasmablastic Anaplastic large cell T-cell rich B-cell lymphoma Primary effusion lymphoma Intravasal B-cell lymphoma Primary mediastinal B-cell lymphoma Mantle zone lymphoma Burkitt or Burkitt-like lymphoma Aggressive marginal zone lymphoma (monocytoid) All risk group allowed Age adjusted IPI 0-3 Previously untreated disease PATIENT CHARACTERISTICS: ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% No other serious concurrent diseases PRIOR CONCURRENT THERAPY: See Disease Characteristics
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frank Hartmann, MD
    Organizational Affiliation
    Universitaetsklinikum des Saarlandes
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21292644
    Citation
    Zwick C, Hartmann F, Zeynalova S, Poschel V, Nickenig C, Reiser M, Lengfelder E, Peter N, Schlimok G, Schubert J, Schmitz N, Loeffler M, Pfreundschuh M; German High-Grade Non-Hodgkin Lymphoma Study Group. Randomized comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia. Ann Oncol. 2011 Aug;22(8):1872-7. doi: 10.1093/annonc/mdq674. Epub 2011 Feb 3.
    Results Reference
    background
    PubMed Identifier
    22337718
    Citation
    Muller C, Murawski N, Wiesen MH, Held G, Poeschel V, Zeynalova S, Wenger M, Nickenig C, Peter N, Lengfelder E, Metzner B, Rixecker T, Zwick C, Pfreundschuh M, Reiser M. The role of sex and weight on rituximab clearance and serum elimination half-life in elderly patients with DLBCL. Blood. 2012 Apr 5;119(14):3276-84. doi: 10.1182/blood-2011-09-380949. Epub 2012 Feb 15.
    Results Reference
    derived
    Links:
    URL
    https://pubmed.ncbi.nlm.nih.gov/21292644/
    Description
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    Pegfilgrastim and Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Aggressive B-Cell Non-Hodgkin Lymphoma

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