Trial Information

BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma

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.