NCT01251107

Study Comparing ABVD vs BEACOPP in Advanced Hodgkin's Lymphoma

Prospective Randomized Comparison of ABVD Versus BEACOPP Chemotherapy With or Without Radiotherapy for Advanced Stage or Unfavorable Hodgkin's Lymphoma (HL)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Fondazione Michelangelo · Academic / Other
• Sex: All
• Age: 17 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Bleomycin	10 mg/m2 IV day 8 during cycles 1 to 8
DRUG	Etoposide	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
DRUG	Doxorubicin	35 mg/2 iv on day 1 during cycles 1 to 4; 25 mg/m2 iv on day 1 during cycles 5 to 8
DRUG	Cyclophosphamide	1250 mg/m2 iv on day 1 during cycles 1 to 4; 650 mg/m2 iv on day 1 during cycles 5 to 8
DRUG	Vincristine	1.4 mg/m2 iv (max 2 mg) on day 8 during cycles 1 to 8
DRUG	Procarbazine	100 mg/m2 po from day 1 to 7 during cycles 1 to 8
DRUG	Prednisone	40 mg/m2 po from day 1 to 14 during cycles 1 to 8
DRUG	Doxorubicin	25 mg/m2 iv on days 1 and 15 in each cycle
DRUG	Bleomycin	10 mg/m2 iv on days 1 and 15 in each cycle
DRUG	Vinblastine	6 mg/m2 iv on days 1 and 15 in each cycle
DRUG	Dacarbazine	375 mg/m2 iv on days 1 and 15 in each cycle

Timeline

• Start date: 2000-03-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2010-12-01
• Last updated: 2015-08-13

Locations

1 site across 1 country: Italy