Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma
- Compare the complete response rate (confirmed or unconfirmed) in patients with
previously untreated aggressive non-Hodgkin's lymphoma treated with cyclophosphamide,
doxorubicin, vincristine, and prednisone with vs without gemcitabine.
- Compare the safety profile of these regimens in these patients.
- Compare the feasibility of these regimens, defined as the proportion of courses given
as scheduled, in these patients.
- Compare freedom from treatment failure in patients treated with these regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified
according to participating center, International Prognostic Index score (0-2 vs 3-5), and
histology (B cell vs T cell). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin
IV, and vincristine IV on day 1 and oral or IV prednisone on days 1-5.
- Arm II: Patients receive CHOP chemotherapy as in arm I and gemcitabine IV over 30
minutes on days 1 and 8.
In both arms, treatment repeats every 3 weeks for 3 courses in the absence of unacceptable
toxicity or progressive disease. Patients achieving partial response or complete or
unconfirmed complete response receive an additional 5 courses of therapy (for a total of 8
Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then
PROJECTED ACCRUAL: A total of 76-82 patients (38-41 per treatment arm) will be accrued for
this study within 2 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Complete response as assessed by Cheson criteria
Igor Aurer, MD, PhD
University Hospital Rebro
United States: Federal Government