Status:
COMPLETED
Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma
Lead Sponsor:
German High-Grade Non-Hodgkin's Lymphoma Study Group
Conditions:
Lymphoma
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
RATIONALE: 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 t...
Detailed Description
OBJECTIVES: Primary * Compare the time to treatment failure in patients with previously untreated, low-risk, aggressive, B-cell non-Hodgkin's lymphoma treated with 2 different schedules of immunoche...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including the following subtypes:
- Grade 3 follicular lymphoma
- Diffuse B-cell lymphoma, including diffuse large cell lymphoma with the following variants:
- Centroblastic
- Immunoblastic
- Plasmablastic
- Anaplastic large cell
- T-cell-rich B-cell lymphoma
- Primary effusion lymphoma
- Intravascular B-cell lymphoma
- Primary mediastinal B-cell lymphoma
- Burkitt's or Burkitt-like lymphoma
- Mantle cell lymphoma (blastoid)
- Aggressive marginal zone lymphoma (monocytoid)
- Previously untreated disease
- CD20-positive disease
- International prognostic index (IPI) score 0 or 1 (age-adjusted)
- Only patients with bulky disease, as defined by largest single or conglomerate tumor ≥ 7.5 cm in diameter, are allowed to have an IPI score of 0
- No mucosa-associated lymphoid tissue (MALT) lymphoma
- No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal)
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Platelet count ≥ 100,000/mm³
- WBC ≥ 2,500/mm³
- No known hypersensitivity to the study medications
- No known HIV-positivity
- No active hepatitis infection
- Not pregnant or lactating
- Negative pregnancy test
- No other malignancy within the past 5 years except carcinoma in situ or basal cell skin cancer
- No impaired left ventricular function
- No severe cardiac arrhythmias
- No other impaired organ function
- No other serious disorder
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
- No prior immunosuppressive treatment with cytostatics
- No concurrent participation in other treatment studies
Exclusion
Key Trial Info
Start Date :
January 2 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00278408
Start Date
January 2 2006
End Date
February 1 2018
Last Update
August 26 2025
Active Locations (152)
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1
Rigshospitalet, Department of Hematology
Copenhagen, Denmark
2
Amtssygehuset i Herlev
Herlev, Denmark
3
GMP Tummes/Weinberg
Aachen, Germany
4
Klinikum St. Marien
Amberg, Germany, D-92224