Overview
Pegfilgrastim and Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Aggressive B-Cell Non-Hodgkin Lymphoma
Status:
Completed
Completed
Trial end date:
2012-02-01
2012-02-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
German High-Grade Non-Hodgkin's Lymphoma Study Group
Universität des SaarlandesTreatments:
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Rituximab
Vincristine
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