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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000454473 | Registry Identifier | PDQ (Physician Data Query) | |
| EU-20534 |
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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.
OBJECTIVES:
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.
Patients with bulky disease or extranodal disease also undergo radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (without rituximab) | Active Comparator | 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 II (with rituximab) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegfilgrastim | Biological | Given subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through chemotherapy administration (up to 112 days respectively) |
| 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) | through chemotherapy administration (up to 112 days respectively) |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to therapy regimens | the median overall treatment duration | through chemotherapy administration (up to 112 days respectively) |
| Antitumor effectivity | progression-free survival |
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DISEASE CHARACTERISTICS:
Diagnosis of CD20-positive B-cell non-Hodgkin lymphoma (NHL)
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:
Mantle zone lymphoma
Burkitt or Burkitt-like lymphoma
Aggressive marginal zone lymphoma (monocytoid)
All risk group allowed
Previously untreated disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Hartmann, MD | Universitaetsklinikum des Saarlandes | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21292644 | Background | 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. | |
| 22337718 |
| Label | URL |
|---|---|
| Related Info | View source |
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| rituximab | Biological | Given IV |
|
| cyclophosphamide | Drug | Given IV |
|
| doxorubicin hydrochloride | Drug | Given IV |
|
| prednisone | Drug | Given orally |
|
| vincristine sulfate | Drug | Given IV |
|
| median time of observation up to 3 years |
| Disease-free survival | period of disease-free survival | median time of observation up to 3 years |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D002051 | Burkitt Lymphoma |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D016399 | Lymphoma, T-Cell |
| D016393 | Lymphoma, B-Cell |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
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| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D011241 | Prednisone |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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