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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00726700
First received: July 31, 2008
Last updated: August 1, 2013
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Lymphoma
Biological: pegfilgrastim
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Side effects [ Designated as safety issue: Yes ]
  • Adherence to therapy regimens [ Designated as safety issue: No ]
  • Antitumor effectivity [ Designated as safety issue: No ]

Estimated Enrollment: 109
Study Start Date: May 2004
Study Completion Date: February 2012
Arms Assigned Interventions
Active Comparator: Arm I (without rituximab)
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.
Biological: pegfilgrastim
Given subcutaneously
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: prednisone
Given orally
Drug: vincristine sulfate
Given IV
Experimental: 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.
Biological: pegfilgrastim
Given subcutaneously
Biological: rituximab
Given IV
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: prednisone
Given orally
Drug: vincristine sulfate
Given IV

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.

  Eligibility

Ages Eligible for Study:   61 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726700

Sponsors and Collaborators
German High-Grade Non-Hodgkin's Lymphoma Study Group
Investigators
Study Chair: Frank Hartmann, MD Universitaetsklinikum des Saarlandes
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00726700     History of Changes
Other Study ID Numbers: DSHNHL-2003-2, CDR0000454473, EU-20534
Study First Received: July 31, 2008
Last Updated: August 1, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Rituximab
Vincristine
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on November 20, 2014