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

Lymphoma, High-grade Clinical Trial

— PETAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554164
• Other study ID #: PETAL trial
• Secondary ID: EudraCT-Number 2
• Status: Completed
• Phase: Phase 3
• First received: November 5, 2007
• Last updated: May 4, 2017
• Start date: November 2007
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1073
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Lymphoma
• Lymphoma, High-grade
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• (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).
• 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).
• (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.
• (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.

Locations

Country	Name	City	State
Germany	Department of Hematology, University Hospital Essen	Essen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Essen	Deutsche Krebshilfe e.V., Bonn (Germany)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to treatment failure		Two years
Secondary	Response rate, overall survival, disease-free survival, toxicity, quality of life		Two years