Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab, or Rituximab and G3139 Phosphorothioate Oligonucleotide (BCL-2 Antisense - NSC-683428) Therapy for Young Patients (< Age 60) With Advanced Stage Diffuse Large B-Cell NHL of Low and Low-Intermediate IPI Risk
PRIMARY OBJECTIVES:
I. To estimate the 1-year progression-free survival probability rate in younger patients
with low and low-intermediate IPI risk advanced stage diffuse large B-cell NHL treated with
8-cycles of CHOP-rituximab. (The CHOP-rituximab arm of this study was permanently closed,
effective 10/15/04.) II. To estimate the 1-year progression-free survival probability rate
in younger patients with low and low-intermediate IPI risk advanced stage diffuse large
B-cell NHL treated with 8 cycles of CHOP-rituximab-G3139.
III. To evaluate response (complete, complete unconfirmed, and partial) and toxicity for
these regimens in this patient population. (The CHOP-rituximab arm of this study was
permanently closed, effective 10/15/04.) IV. To estimate the 1-year progression-free
survival and response rate in the subset of patients overexpressing bcl-2 protein.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
age-adjusted International Prognostic Index (0 vs 1). Patients are randomized to 1 of 2
treatment arms. (Arm I closed to accrual as of 9/21/04.)
ARM I (closed to accrual as of 9/21/04): Patients receive rituximab IV over 6 hours,
cyclophosphamide IV over 15-45 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV
over 5-15 minutes on day 1 and oral prednisone on days 1-5.
ARM II: Patients receive oblimersen IV continuously on days 1-7; rituximab IV over 6 hours,
cyclophosphamide IV over 15-45 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV
over 5-15 minutes on day 5; and oral prednisone on days 5-10.
In both arms, treatment repeats every 21 days for up to 8 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then
annually for up to 5 years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
1 year PFS
At 1 year
No
Steven Bernstein
Principal Investigator
Southwest Oncology Group
United States: Food and Drug Administration
NCI-2012-03031
NCT00080847
March 2004
Name | Location |
---|---|
Southwest Oncology Group | San Antonio, Texas 78245 |