SWOG-9704 A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+ B Cell Lymphomas (With Possible Late Autologous Stem Cell Transplant) for Patients With Diffuse Aggressive Non-Hodgkin's Lymphoma in the High-Intermediate and High Risk International Classification Prognostic Groups
OBJECTIVES:
- Compare the overall survival and progression-free survival of patients with
intermediate- or high-grade non-Hodgkin's lymphoma treated with high-dose
chemoradiotherapy and autologous peripheral blood stem cell transplantation (APBSCT) vs
conventional dose cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (or
CHOP plus rituximab for CD20+ disease) with possible late APBSCT.
- Compare the toxic effects of these regimens in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to disease risk
(intermediate-high vs high).
Patients receive CHOP chemotherapy comprising cyclophosphamide IV over 15 minutes,
doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Patients with
CD20-positive disease also receive rituximab IV on day 1 (or day 0 during course 1 only).
Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or
unacceptable toxicity.
Within 35 days of completing the fifth course, patients with partial or complete response
are randomized to one of two treatment arms.
- Arm I: Patients receive CHOP (or CHOP plus rituximab [CHOP-R]) as above. Treatment
repeats every 3 weeks for 3 additional courses. After completion of chemotherapy,
patients are encouraged to undergo harvest of peripheral blood stem cells (PBSC) for
possible use at time of relapse. After completion of 8 courses, patients receive no
additional therapy until disease progression or biopsy-proven disease.
- Arm II: Patients receive one additional course of CHOP/CHOP-R followed by filgrastim
(G-CSF), sargramostim (GM-CSF), or other colony-stimulating factors used singly or in
combination according to center preference. PBSC are harvested and selected for CD34+
cells. Patients under age 61 receive one of two preparative regimens: a total body
irradiation (TBI)-based regimen comprising irradiation administered twice daily on days
-8 to -5, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 1 hour on
day -2 OR carmustine IV over 2 hours on days -6 to -4 and etoposide and
cyclophosphamide as in the TBI-based regimen. Patients age 61 to 65 receive the
augmented regimen comprising carmustine, etoposide, and cyclophosphamide as above.
Patients receive involved field radiotherapy prior to the preparative regimen only if
there is biopsy-proven residual bulk disease and at the discretion of the center. PBSC
are reinfused 36-48 hours after completion of cyclophosphamide. If both bone marrow and
PBSC are harvested, bone marrow is reinfused on day 0 and then PBSC are reinfused
either the same day or the following day.
Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: Approximately 360 patients (at least 135 per treatment arm) will be
accrued for this study within 5 years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival
until death
No
Patrick J. Stiff, MD
Study Chair
Loyola University
United States: Food and Drug Administration
CDR0000065658
NCT00004031
July 1997
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