Positron Emission Tomography Guided Therapy of Aggressive Non-Hodgkin's Lymphomas — PETAL  

Lymphoma, High-grade Clinical Trial

Official title: Positron Emission Tomography Guided Therapy of Aggressive Non-Hodgkin's Lymphomas

Status Completed

Clinical Trial Summary

The main purpose of the PETAL trial is to determine whether patients with aggressive non-Hodgkin's lymphomas with a persistently positive PET scan after two cycles of chemotherapy benefit from a change of the treatment protocol.

Clinical Trial Description

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). ;

Related Conditions & MeSH terms

• Aggression
• Lymphoma
• Lymphoma, High-grade
• Lymphoma, Non-Hodgkin

• NCT number: NCT00554164
• Study type: Interventional
• Source: University Hospital, Essen
• Status: Completed
• Phase: Phase 3
• Start date: November 2007
• Completion date: March 2017