Pegfilgrastim and Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Aggressive B-Cell Non-Hodgkin Lymphoma
NCT ID: NCT00726700
Last Updated: 2021-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
109 participants
INTERVENTIONAL
2004-05-31
2012-02-29
Brief Summary
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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.
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A comparatiVe Study on Efficacy and Safety of Lipegfilgrastim in Comparison to Pegfilgrastim in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
Study Groups
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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.
pegfilgrastim
Given subcutaneously
cyclophosphamide
Given IV
doxorubicin hydrochloride
Given IV
prednisone
Given orally
vincristine sulfate
Given IV
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.
pegfilgrastim
Given subcutaneously
rituximab
Given IV
cyclophosphamide
Given IV
doxorubicin hydrochloride
Given IV
prednisone
Given orally
vincristine sulfate
Given IV
Interventions
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pegfilgrastim
Given subcutaneously
rituximab
Given IV
cyclophosphamide
Given IV
doxorubicin hydrochloride
Given IV
prednisone
Given orally
vincristine sulfate
Given IV
Eligibility Criteria
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Inclusion Criteria
* 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
61 Years
80 Years
ALL
No
Sponsors
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Universität des Saarlandes
OTHER
Responsible Party
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Principal Investigators
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Frank Hartmann, MD
Role: STUDY_CHAIR
Universitaetsklinikum des Saarlandes
References
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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.
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.
Related Links
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Related Info
Other Identifiers
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CDR0000454473
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20534
Identifier Type: -
Identifier Source: secondary_id
DSHNHL-2003-2
Identifier Type: -
Identifier Source: org_study_id
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