Positron Emission Tomography Guided Therapy of Aggressive Non-Hodgkin's Lymphomas
Positron emission tomography performed after two cycles of (R-)CHOP chemotherapy
(interim-PET) has been shown to predict long-term outcome in patients with aggressive
non-Hodgkin's lymphomas. Patients with early normalization of pathological PET findings have
an excellent prognosis, while patients with a persistently pathological PET scan have a high
risk of non-response or relapse.
Patients with a negative interim-PET scan (part A of the trial) will be randomized to
receive either another four cycles of the (R-)CHOP regimen (arm A1) or four cycles of the
(R-)CHOP regimen plus two additional doses of rituximab (arm A2). Randomisation in part A of
the trial was stopped when the number of patients required was reached (128 patients in each
treatment arm). Since then patients have been uniformly treated according to arm A2.
Patients with a persistently positive interim-PET scan (part B of the trial) will be
randomized to either continue treatment with another six (R-)CHOP cycles (arm B1) or switch
to an alternative protocol used for the treatment of Burkitt's lymphoma (arm B2: six blocks
according to the so-called B-ALL protocol of the German ALL study group).
Patients refractory to or relapsing within two years after treatment according to parts A or
B of the trial will receive age-adapted salvage protocols (patients < 60 years: high-dose
chemotherapy with autologous stem cell transplantation; patients > 60 years: (R-)ESHAP
protocol)(part C of the trial).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to treatment failure
Ulrich Duehrsen, Prof. Dr.
Department of Hematology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany
Germany: Federal Institute for Drugs and Medical Devices