A Randomised Study of High Dose Chemotherapy/Radiotherapy and Autologous Bone Marrow Transplantation in Patients With High Grade Malignant Non-Hodgkin's Lymphoma (Kiel Classification) According to Prognostic Groups
- Assess the rate of remission in patients with aggressive non-Hodgkin's lymphoma treated
with high-dose chemotherapy and radiotherapy plus autologous bone marrow
- Determine the efficacy and toxic effects of this regimen in these patients.
OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are
stratified according to risk group (good vs intermediate vs poor).
Patients undergo harvest of autologous bone marrow stem cells after priming chemotherapy and
Patients receive induction chemotherapy comprising the CHOP or VAPEC-B regimen. The CHOP
regimen consists of vincristine (VCR) IV, cyclophosphamide (CTX) IV, and doxorubicin (DOX)
IV on day 1 and oral prednisolone (PRDL) on days 1-5. Treatment repeats every 3 weeks for
six courses. The VAPEC-B regimen consists of DOX IV on days 1, 15, 29, 43, 57, and 71; CTX
IV on days 1, 29, and 57; VCR IV on days 8, 22, 36, 50, and 64; bleomycin IV on days 8, 36,
64; oral etoposide (VP-16) on days 15-19, 43-47, and 71-75; and oral PRDL daily for 13
Patients then may undergo radiotherapy for 2-3 weeks to areas of original bulk or residual
- Good-risk group: Patients are randomized to one of two treatment arms.
- Arm I: Patients receive no further treatment.
- Arm II: Patients receive melphalan (L-PAM) before or after total body irradiation
(TBI), which is delivered in 3 fractions over 24 hours. After completion of
radiotherapy, patients undergo autologous bone marrow transplantation (AuBMT).
- Intermediate- or poor-risk group: Patients are randomized one of three treatment arms.
- Arm III: Patients receive L-PAM IV on day -2 and AuBMT on day 0.
- Arm IV: Patients receive treatment as in arm II.
- Arm V: Patients receive carmustine IV on day -6, VP-16 IV once daily and
cytarabine IV twice daily on days -5 to -2, and L-PAM IV on day -1. Radiotherapy
to bulk disease begins after completion of chemotherapy. Patients undergo AuBMT on
Patients are followed monthly for 3 months, every 2 months for 1 year, every 4 months for 2
years, and then every 6 months thereafter.
PROJECTED ACCRUAL: Not specified
Allocation: Randomized, Primary Purpose: Treatment
Stephen J. Proctor, MD, FRCP, FRCPath
Newcastle-upon-Tyne Hospitals NHS Trust
United States: Federal Government