Know Cancer

forgot password

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

Phase 3
18 Years
80 Years
Open (Enrolling)
Lymphoma, High-grade

Thank you

Trial Information

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).

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to treatment failure

Outcome Time Frame:

Two years

Safety Issue:


Principal Investigator

Ulrich Duehrsen, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Hematology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

PETAL trial



Start Date:

November 2007

Completion Date:

December 2014

Related Keywords:

  • Lymphoma, High-Grade
  • Aggressive non-Hodgkin's lymphoma
  • Positron emission tomography
  • Chemotherapy
  • Aggression
  • Lymphoma
  • Lymphoma, Non-Hodgkin