Lymphoma, High-grade
Conditions
Keywords
Aggressive non-Hodgkin's lymphoma, Positron emission tomography, Chemotherapy
Brief 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.
Detailed 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).
Interventions
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).
DRUGB-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).
Sponsors
Deutsche Krebshilfe e.V., Bonn (Germany)
University Hospital, Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to treatment failure | Two years |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, overall survival, disease-free survival, toxicity, quality of life | Two years |
Countries
Germany
Outcome results
None listed