Overview

This trial is active, not recruiting.

Condition lymphoma, high-grade
Treatments (r-)chop protocol, b-all protocol
Phase phase 3
Sponsor University Hospital, Essen
Collaborator Deutsche Krebshilfe e.V., Bonn (Germany)
Start date November 2007
End date March 2017
Trial size 696 participants
Trial identifier NCT00554164, EudraCT-Number 2006-001641-33, Krebshilfe Grant 107592, PETAL 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Six cycles of the (R-)CHOP regimen.
(r-)chop protocol
Patients with a persistently positive interim-PET scan assigned to arm B1 will receive another six cycles of the (R-)CHOP regimen (rituximab, cyclophosphamide, doxorubicine, vincristine, prednisone).
(Experimental)
Six blocks of the B-ALL protocol.
b-all protocol
Patients with a persistently positive interim-PET scan assigned to arm B2 will receive six blocks of the B-ALL protocol (rituximab, methotrexate, ifosfamide, etoposide, cytarabine, vincristine, cyclophosphamide, doxorubicine, vindesine, dexamethasone).
(Active Comparator)
Four cycles of the (R-)CHOP regimen.
(r-)chop protocol
Patients with a negative interim-PET scan assigned to arm A1 will receive another four cycles of the (R-)CHOP regimen (rituximab, cyclophosphamide, doxorubicine, vincristine, prednisone). Arm A1 was closed when the number of patients required for the randomisation between arms A1 and A2 was reached.
(Active Comparator)
Four cycles of the (R-)CHOP regimen plus two additional doses rituximab.
(r-)chop protocol
Patients with a negative interim-PET scan assigned to arm A2 will receive another four cycles of the (R-)CHOP regimen (rituximab, cyclophosphamide, doxorubicine, vincristine, prednisone) plus two additional doses rituximab. Since the number of patients required for the randomisation between arms A1 and A2 has been reached, all patients with a negative interim-PET scan are treated according to arm A2.

Primary Outcomes

Measure
Time to treatment failure
time frame: Two years

Secondary Outcomes

Measure
Response rate, overall survival, disease-free survival, toxicity, quality of life
time frame: Two years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Positron Emission Tomography Guided Therapy of Aggressive Non-Hodgkin's Lymphomas
Principal investigator Ulrich Duehrsen, Prof. Dr.
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University Hospital, Essen.