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

Phase 3

Completed

• Conditions: Lymphoma, High-grade
• Interventions: Drug: (R-)CHOP protocol; Drug: B-ALL protocol

• Registration Number: NCT00554164
• Lead Sponsor: University Hospital, Essen

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-05
• Study First Submitted QC: 2007-11-05
• Study First Posted: 2007-11-06
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1073

Inclusion Criteria

• Aggressive B-cell or T-cell non-Hodgkin's lymphoma
• Pathological pre-treatment PET scan
• Performance status ECOG 0-3
• Age 18 - 80 years
• Ability to understand the purpose of the study and act accordingly
• Willingness to use adequate contraception
• Informed consent

Exclusion Criteria

• Burkitt's lymphoma
• Primary central nervous system lymphoma
• Previous chemo- and/or radiotherapy
• Other cancer within preceding 5 years
• HIV infection, active viral hepatitis or other uncontrolled infection
• Other medical conditions precluding administration of planned therapy
• Pregnancy or lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B1	(R-)CHOP protocol	Six cycles of the (R-)CHOP regimen.
B2	B-ALL protocol	Six blocks of the B-ALL protocol.
A1	(R-)CHOP protocol	Four cycles of the (R-)CHOP regimen.
A2	(R-)CHOP protocol	Four cycles of the (R-)CHOP regimen plus two additional doses rituximab.

Primary Outcome Measures

Name	Time	Method
Time to treatment failure	Two years

Secondary Outcome Measures

Name	Time	Method
Response rate, overall survival, disease-free survival, toxicity, quality of life	Two years

Trial Locations

Locations (1)

Department of Hematology, University Hospital Essen; 🇩🇪 Essen, Germany