Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Diagnostic, Treatment Active 18 to 80 Other PETAL trial EudraCT-Number 2006-001641-33, Krebshilfe Grant 107592, NCT00554164

Trial Description

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.

Further Study Information

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 will receive another four cycles of the (R-)CHOP regimen (part A of the trial).

Patients with a persistently positive interim-PET scan will be randomized to either continue treatment with another six (R-)CHOP cycles (arm 1) or switch to an alternative protocol used for the treatment of Burkitt's lymphoma (six blocks according to the so-called B-ALL protocol of the German ALL study group)(part B of the trial).

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).

Eligibility Criteria

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 Contact Information

Trial Lead Organizations/Sponsors

Universitaetsklinikum Essen

Ulrich Duehrsen, Prof. Dr.

Principal Investigator

Ulrich Duehrsen, Prof. Dr.		Ph: 0049-201-723-2417 Ext.2417
		Email: ulrich.duehrsen@uk-essen.de

Andreas Huettmann, PD Dr.		Ph: 0049-201-723-1861 Ext.1861
		Email: petal@uk-essen.de

Germany
	45122 Essen
	Universitaetsklinikum Essen
		Ulrich Duehrsen, Prof. Dr.	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00554164
Information obtained from ClinicalTrials.gov on July 16, 2008