Phase III Trial Comparing CHOP ot PMitCEBO in Good Risk Patients With Histologically Aggresive Non Hodgkin's Lymphoma
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Overall survival in patients treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP)
No
Ruth Pettengell, MD
Study Chair
St. George's Hospital
United States: Federal Government
BNLI-CHOPVPMITCEBO-GOODRISK
NCT00005867
January 1998
August 2007
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