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

University Hospital Essen

Status and phase: Completed; Phase 3

Conditions: Lymphoma, High-grade

Treatments: Drug: (R-)CHOP protocol; Drug: B-ALL protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT00554164

PETAL trial

Krebshilfe Grant 107592

EudraCT-Number 2006-001641-33

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,073 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,073 participants in 4 patient groups

B1

Active Comparator group

Description:

Six cycles of the (R-)CHOP regimen.

Treatment:

Drug: (R-)CHOP protocol

Drug: (R-)CHOP protocol

Drug: (R-)CHOP protocol

B2

Experimental group

Description:

Six blocks of the B-ALL protocol.

Treatment:

Drug: B-ALL protocol

A1

Active Comparator group

Description:

Four cycles of the (R-)CHOP regimen.

Treatment:

Drug: (R-)CHOP protocol

Drug: (R-)CHOP protocol

Drug: (R-)CHOP protocol

A2

Active Comparator group

Description:

Four cycles of the (R-)CHOP regimen plus two additional doses rituximab.

Treatment:

Drug: (R-)CHOP protocol

Drug: (R-)CHOP protocol

Drug: (R-)CHOP protocol