Combination Chemotherapy in Treating Patients With Aggressive 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. It is not yet known which regimen of combination chemotherapy is
      most effective for non-Hodgkin's lymphoma.

      PURPOSE: This randomized phase III trial is studying two regimens of combination chemotherapy
      and comparing how well they work in treating patients with aggressive non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the overall survival, failure free survival, disease specific survival, relapse
           free survival, and response rate in patients with aggressive non-Hodgkin's lymphoma
           treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and
           prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and
           prednisolone (CHOP).

        -  Compare the early and late toxicities of these regimens in these patients.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
      treatment arms.

        -  Arm I: Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1
           and vincristine and bleomycin IV on day 8. Treatment continues every 14 days for a
           maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
           Patients also receive oral prednisolone daily on courses 1 and 2 and every other day
           beginning on course 3 and continuing until the end of treatment.

        -  Arm II: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day
           1 and oral prednisolone on days 1-5. Treatment continues every 21 days for a maximum of
           8 courses in the absence of disease progression or unacceptable toxicity.

      Patients are followed at 4 weeks, then every 3 months for 1 year, every 6 months for 5 years,
      and then annually thereafter.

      PROJECTED ACCRUAL: A total of 310 patients (155 per arm) will be accrued for this study over
      5 years.
    

Intervention name(s): bleomycin sulfate; CHOP regimen; cyclophosphamide; doxorubicin hydrochloride; etoposide; mitoxantrone hydrochloride; prednisolone; vincristine sulfate
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Prednisolone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Mitoxantrone; Bleomycin
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage I grade 3 follicular lymphoma; stage I adult diffuse mixed cell lymphoma; stage I adult diffuse large cell lymphoma; stage I adult immunoblastic large cell lymphoma; stage III grade 3 follicular lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage IV grade 3 follicular lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; contiguous stage II grade 3 follicular lymphoma; contiguous stage II adult diffuse mixed cell lymphoma; contiguous stage II adult immunoblastic large cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II grade 3 follicular lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma