Status:
COMPLETED
Pegfilgrastim and Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Aggressive B-Cell Non-Hodgkin Lymphoma
Lead Sponsor:
Universität des Saarlandes
Conditions:
Lymphoma
Eligibility:
All Genders
61-80 years
Phase:
PHASE2
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 the...
Detailed Description
OBJECTIVES: * Determine the side effects of pegfilgrastim and cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) with or without rituximab in older patients with aggressi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00726700
Start Date
May 1 2004
End Date
February 1 2012
Last Update
July 7 2021
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