Combination Chemotherapy With or Without Rituximab in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer
      cells and either kill them or deliver cancer-killing substances to them without harming
      normal cells. It is not yet known whether combination chemotherapy plus rituximab is more
      effective than combination chemotherapy alone for non-Hodgkin's lymphoma.

      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
      with or without rituximab in treating patients who have newly diagnosed non-Hodgkin's
      lymphoma that has not been treated previously.
    

Detailed description: 
      OBJECTIVES: I. Determine whether the addition of rituximab to cyclophosphamide, doxorubicin,
      vincristine, and prednisone (CHOP) increases the failure-free survival of patients with newly
      diagnosed, previously untreated, aggressive B-cell non-Hodgkin's lymphoma. II. Determine
      whether the addition of rituximab changes the toxicity profile attributed to CHOP
      chemotherapy in this patient population.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified by center,
      histology (diffuse small cleaved cell, diffuse mixed, and diffuse large cell vs immunoblastic
      large cell, mantle cell, and marginal zone), and risk group (low vs intermediate vs high).
      Patients enter one of two treatment arms: Arm I: Patients receive rituximab IV on day 1,
      followed by cyclophosphamide IV, doxorubicin IV, vincristine IV, and oral prednisone for 5
      consecutive days beginning on day 3. Arm II: Patients receive cyclophosphamide IV,
      doxorubicin IV, vincristine IV, and oral prednisone daily for 5 consecutive days beginning on
      day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease
      progression or unacceptable toxicity. Patients will be followed for 3 years.

      PROJECTED ACCRUAL: A total of 270 patients (135 per treatment arm) will be accrued for this
      study within 3 years.
    

Intervention name(s): rituximab; CHOP regimen; cyclophosphamide; doxorubicin hydrochloride; prednisone; vincristine sulfate
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Cyclophosphamide, vincristine and doxorubicin as a drip into the bloodstream (intravenously) and prednisolone (steroid) as tablets taken with or after food.
Other intervention name(s): Rituxan; cyclophosphamide, vincristine, doxorubicin, prednisolone; chemotherapy; Lipodox, Lipodox 50, and Doxil; Prednisone Intensol, Deltasone, Rayos, steroid; Oncovin
Intervention MeSH terms: Prednisone; Prednisolone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage II adult diffuse small cleaved cell lymphoma; stage II adult diffuse mixed cell lymphoma; stage II adult diffuse large cell lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse large cell lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; anaplastic large cell lymphoma; stage II mantle cell lymphoma; stage II small lymphocytic lymphoma; stage II marginal zone lymphoma; stage III small lymphocytic lymphoma; stage III marginal zone lymphoma; stage IV small lymphocytic lymphoma; stage IV marginal zone lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma