Study Comparing ABVD vs BEACOPP in Advanced Hodgkin's Lymphoma
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The choice of a preferred first-line treatment requires balancing the desire for optimal
      disease control with the occurrence of early and late treatment-related effects. To fully
      assess this balance, the treatment decision process should ideally take into account the
      outcome following a consistent second-line therapy, in particular when tolerated, widely
      applicable and highly effective salvage regimens exist, like in Hodgkin lymphoma failing
      initial chemotherapy.
    

Detailed description: 
      During the last two decades ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) has been
      considered as the standard of care for advanced HL, however 20-30% of the patients fail to
      achieve a durable complete remission and need a salvage treatment. After a state-of-the
      art-salvage program including high-dose chemotherapy and autologous hematopoietic stem cell
      support (ASCT) at least half of these patients achieve a durable disease control. Recently
      the German Hodgkin Study Group (GHSG) has developed a new regimen, BEACOPP (bleomycin,
      etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone),
      administered with or without dose escalation. In an interim analysis after 23 months
      follow-up, BEACOPP demonstrated a higher activity compared to COPP/ABVD with a superior
      freedom from treatment failure (84% versus 75%, P=.034). Despite the improved efficacy a
      substantial proportion of patients receiving escalated BEACOPP experienced severe acute
      hematologic toxicity (grade 3-4 leucopoenia, thrombocytopenia and anemia occurred in 78% ,
      36% and 27% of the cycles administered, respectively) and 1.8% fatal acute toxicities were
      reported. Moreover of greater concern is the incidence of almost fatal secondary acute
      leukemia and myelodysplastic syndrome (3 cases in 323 patients). The choice of first-line
      treatment requires balancing the desire for optimal disease control with the occurrence of
      early and late treatment-related toxicities. Long-term outcome following an optimal salvage
      treatment, consisting in high-dose chemotherapy with ASCT should also be taken into
      consideration. In the present study we plan to compare the efficacy and toxicity of two
      therapeutic strategies consisting in two different first-line treatments followed by a
      pre-planned salvage program, when indicated
    

Intervention name(s): Bleomycin; Etoposide; Doxorubicin; Cyclophosphamide; Vincristine; Procarbazine; Prednisone; Doxorubicin; Bleomycin; Vinblastine; Dacarbazine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 10 mg/m2 IV day 8 during cycles 1 to 8; 200 mg/m2 iv on days 1 to 3 during cycles 1 to 4; 100 mg/m2 iv on days 1 to 3 during cycles 5 to 8; 35 mg/2 iv on day 1 during cycles 1 to 4; 25 mg/m2 iv on day 1 during cycles 5 to 8; 1250 mg/m2 iv on day 1 during cycles 1 to 4; 650 mg/m2 iv on day 1 during cycles 5 to 8; 1.4 mg/m2 iv (max 2 mg) on day 8 during cycles 1 to 8; 100 mg/m2 po from day 1 to 7 during cycles 1 to 8; 40 mg/m2 po from day 1 to 14 during cycles 1 to 8; 25 mg/m2 iv on days 1 and 15 in each cycle; 10 mg/m2 iv on days 1 and 15 in each cycle; 6 mg/m2 iv on days 1 and 15 in each cycle; 375 mg/m2 iv on days 1 and 15 in each cycle
Other intervention name(s): Bleomicina Teva; VP-16, Etoposide Teva; Adriblastina Pfizer; Endoxan Baxter; Vincristina Teva Italia; Natulan; Deltacortene; Adriblastina Pfizer; Bleomicina Teva; Velbe; Dacarbazina Medac
Intervention MeSH terms: Prednisone; Cyclophosphamide; Dacarbazine; Doxorubicin; Liposomal doxorubicin; Etoposide; Etoposide phosphate; Vincristine; Bleomycin; Vinblastine; Procarbazine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hodgkin lymphoma; ABVD; BEACOPP; Salvage high dose chemotherapy