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
61 Years
80 Years
Both
Lymphoma
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Side effects
Safety Issue:
Yes
Principal Investigator
Frank Hartmann, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Universitaetsklinikum des Saarlandes
Authority:
United States: Federal Government
Study ID:
CDR0000454473
NCT ID:
NCT00726700
Start Date:
May 2004
Completion Date:
Related Keywords:
- Lymphoma
- 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
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
- Lymphoma, Large-Cell, Immunoblastic
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