Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed 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 chemotherapy is more effective with or without rituximab
      for relapsed non-Hodgkin's lymphoma.

      PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab
      to see how well they work compared to combination chemotherapy alone in treating patients
      with relapsed non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the response rate and quality of remission in patients with relapsed follicular
           non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and
           prednisone (CHOP) with or without rituximab.

        -  Compare the event-free survival and overall survival of patients treated with these
           regimens.

        -  Determine the effect of rituximab as maintenance therapy on progression-free survival of
           these patients.

      OUTLINE: This is a randomized, multicenter study.

        -  Induction: Patients are randomized to one of two treatment arms. Patients are stratified
           according to participating center, prior treatment with purine analogues, age, number of
           prior induction treatments and best response obtained (complete vs partial remission vs
           no change/progressive disease), time since diagnosis (less than 2 years vs more than 2
           years), and bulky disease (less than 10 cm vs greater than 10 cm).

             -  Arm I (closed as of 12/20/04): Patients receive induction chemotherapy comprising
                cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral
                prednisone on days 1-5 (CHOP chemotherapy). Treatment repeats every 3 weeks for 6
                courses in the absence of disease progression or unacceptable toxicity.

             -  Arm II: Patients receive CHOP chemotherapy as in arm I. Rituximab IV is
                administered 1 hour after prednisone and before the IV drugs.

        -  Maintenance: Patients who achieve partial or complete remission are then randomized to
           one of two treatment arms. Patients are stratified according to rituximab administration
           during induction (yes vs no), quality of the response (complete vs partial remission vs
           no change/progressive disease), and participating center.

             -  Arm I: Patients receive no further therapy.

             -  Arm II: Beginning 8 weeks after the last CHOP course, patients receive rituximab IV
                once every 3 months for up to 2 years in the absence of disease progression or
                unacceptable toxicity.

      Patients are followed every 3 months for 2 years and then every 4 months thereafter.

      PROJECTED ACCRUAL: A total of 752 patients will be accrued for this study within 6 years.
    

Intervention name(s): rituximab; CHOP regimen; cyclophosphamide; doxorubicin hydrochloride; prednisone; vincristine sulfate
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma