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

NCT00726700 | Completed Phase 2

• 3 other identifiers: DSHNHL-2003-2CDR0000454473EU-20534
• Study Type: interventional
• Target: 109
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (3)

• Adherence to therapy regimens

  through chemotherapy administration (up to 112 days respectively)

• Antitumor effectivity

  median time of observation up to 3 years

• Disease-free survival

  median time of observation up to 3 years

Study Arms (2)

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.

Biological: pegfilgrastim; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate

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.

Biological: pegfilgrastim; Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate

Interventions

pegfilgrastim BIOLOGICAL

Given subcutaneously

Arm I (without rituximab); Arm II (with rituximab)

rituximab BIOLOGICAL

Given IV

Arm II (with rituximab)

cyclophosphamide DRUG

Given IV

Arm I (without rituximab); Arm II (with rituximab)

doxorubicin hydrochloride DRUG

Given IV

Arm I (without rituximab); Arm II (with rituximab)

prednisone DRUG

Given orally

Arm I (without rituximab); Arm II (with rituximab)

vincristine sulfate DRUG

Given IV

Arm I (without rituximab); Arm II (with rituximab)

Eligibility Criteria

• Age: 61 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Universität des Saarlandes: lead

Related Publications (2)

• 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.

  PMID: 21292644 BACKGROUND

• 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.

  PMID: 22337718 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Burkitt Lymphoma; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone

Interventions

pegfilgrastim; Rituximab; Cyclophosphamide; Doxorubicin; Prednisone; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Lymphoma, T-Cell; Lymphoma, B-Cell; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Frank Hartmann, MD

  Universitaetsklinikum des Saarlandes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 1, 2008
• Study Start: May 1, 2004
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: July 7, 2021

Record last verified: 2021-07