Positron Emission Tomography Guided Therapy of Aggressive Non-Hodgkin's Lymphomas
Condition: Lymphoma, High-grade
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Aggression
Study type: Interventional
Phase: Phase 3

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).
    

Intervention name(s): (R-)CHOP protocol; B-ALL protocol; (R-)CHOP protocol; (R-)CHOP protocol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.
Intervention MeSH terms: Prednisone; Cyclophosphamide; Doxorubicin; Vincristine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aggressive non-Hodgkin's lymphoma; Positron emission tomography; Chemotherapy