Rituximab and Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma (NCT00278421) | Clinical Trial Compass
CompletedPhase 3
Rituximab and Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma
Germany592 participantsStarted 2005-11
Plain-language 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 the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which schedule of rituximab and combination chemotherapy is more effective in treating non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkin's lymphoma.
Who can participate
Age range18 Years – 60 Years
SexALL
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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 any of 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
* No bulky disease
* Largest single or conglomerate tumor \< 7.5 cm in diameter
* No mucosa-associated lymphoid tissue (MALT) lymphoma
* No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal)
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Platelet count ≥ 100,000/mm\^3
* WBC ≥ 2,500/mm\^3
* Lactate dehydrogenase normal
* Not pregnant or lactating
* Fertile patients must use effective contraception during and for 1 year after study participation
* Negative pregnancy test
* No known hypersensitivity to the study medications
* No known HIV-positivity
* No active hepatitis infection
* No impaired left ventricular function
* No severe cardiac arrhythmias
* No other impaired organ function
* No other serious disorder
* No other malignancy wit…
What they're measuring
1
Time to treatment failure (TTF) measured from day 1 of course 1 of Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (CHOP) therapy up to 3 years on study with life-long follow-up
Timeframe: through study completion
Trial details
NCT IDNCT00278421
SponsorGerman High-Grade Non-Hodgkin's Lymphoma Study Group