A Phase 3 interventional study of (R-)CHOP protocol and B-ALL protocol in Lymphoma, High-grade, sponsored by University Hospital, Essen. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-05-05.
Sponsored by University Hospital, Essen · Phase 3, Interventional, and Treatment
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.
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).
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 1,073 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →University Hospital, Essen is the lead sponsor of 111 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
Six cycles of the (R-)CHOP regimen.
Drug: (R-)CHOP protocol
Six blocks of the B-ALL protocol.
Drug: B-ALL protocol
Four cycles of the (R-)CHOP regimen.
Drug: (R-)CHOP protocol
Four cycles of the (R-)CHOP regimen plus two additional doses rituximab.
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).
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).
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.
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.
Time to treatment failure
Time frame: Two years
Response rate, overall survival, disease-free survival, toxicity, quality of life
Time frame: Two years
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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University Hospital, Essen