Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
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. Combining more than one drug may kill more cancer cells. It is
      not yet known which combination chemotherapy regimen is more effective in treating stage III
      or stage IV Hodgkin's lymphoma.

      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination
      chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Compare event-free survival of patients with stage III or IV Hodgkin's lymphoma treated
           with bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and
           prednisone vs doxorubicin, bleomycin, vinblastine, and dacarbazine.

        -  Compare complete response, disease-free survival, and overall survival of patients
           treated with these regimens.

        -  Compare quality of life of patients treated with these regimens.

        -  Compare occurrence of second malignancies in patients treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      International Prognostic Score (3 vs 4 or more) and participating center. Patients are
      randomized to 1 of 2 treatment arms.

        -  Arm I (BEACOPP): Patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV
           on day 1; etoposide IV over 30 minutes on days 1-3; oral procarbazine on days 1-7; oral
           prednisone on days 1-14; and vincristine IV and bleomycin IV or intramuscularly (IM) on
           day 8. Patients may receive dexamethasone in place of prednisone. Patients also receive
           filgrastim (G-CSF) subcutaneously (SC) beginning on day 9 and continuing until blood
           counts recover or pegfilgrastim SC on day 9 only. Treatment repeats every 22 days for 8
           courses (4 courses escalated dose followed by 4 courses baseline dose) in the absence of
           disease progression or unacceptable toxicity.

        -  Arm II (ABVD): Patients receive doxorubicin IV over 5 minutes, bleomycin IV or IM,
           vinblastine IV, and dacarbazine IV over 5-10 minutes on days 1 and 15. Treatment repeats
           every 28 days for 8 courses in the absence of disease progression or unacceptable
           toxicity.

      Quality of life is assessed at baseline, at the end of therapy, and then annually for 10
      years.

      Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 550 patients (225 per treatment arm) will be accrued for this
      study within 5.5 years.
    

Intervention name(s): bleomycin sulfate; filgrastim; pegfilgrastim; ABVD regimen; BEACOPP regimen; cyclophosphamide; dacarbazine; doxorubicin hydrochloride; etoposide; prednisone; procarbazine hydrochloride; vinblastine sulfate; vincristine sulfate
Intervention type(s): Biological; Biological; Biological; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Prednisone; Cyclophosphamide; Dacarbazine; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Bleomycin; Vinblastine; Procarbazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult lymphocyte depletion Hodgkin lymphoma; adult mixed cellularity Hodgkin lymphoma; adult nodular sclerosis Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma