Study Comparing ABVD vs BEACOPP in Advanced Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Michelangelo
• Treatments: Bleomycin; Cyclophosphamide; Dacarbazine; Doxorubicin; Etoposide; Etoposide phosphate; Liposomal doxorubicin; Prednisone; Procarbazine; Vinblastine; Vincristine

Criteria

Inclusion Criteria:

• Histologically confirmed, newly diagnosed Hodgkin's lymphoma (pathological review diagnosis available)

• No prior treatment

• Stage II B, III A and B, IV A and B

• Normal hematopoietic function as measured by leucocytes equal to or greater than 3500/mm3, neutrophils equal to or greater than 1500/mm3, platelets equal to or greater than 100000/mm3

• Normal renal function (serum creatinine < 1,5x ULN) and normal liver function (SGOT/SGPT equal to or lower than 2.5x ULN; bilirubin equal to or lower than 1.5x ULN)

• No significant history or current evidence of cardiovascular disease, or major respiratory disease

• No severe neurologic or psychiatric disease

• No other malignancy except basal cell carcinoma of the skin and/or in situ cervical carcinoma of the uterus

• Serological negativity for hepatitis B or C or HIV infection

• ECOG performance status equal to or lower than 2

• Life expectancy of at least three months

• Effective contraception in all patients and a negative pregnancy test for women of childbearing potential

• Written informed consent and consent to a regular follow-up in the outpatient clinic

Exclusion criteria:

• Sever central nervous system or psychiatric disease

• History or current evidence of clinically significant cardiac disease (congestive heart failure, uncontrolled hypertension, unstable coronary artery disease or myocardial infarction or severe arrhythmias. Left ventricular ejection fraction < 50% at rest by echocardiography or < 55% by isotopic measurement

• Serological positivity for HBV, HCV or HIV

• History or current evidence of malignancy other than basal cell carcinoma of the skin, carcinoma in situ of the cervix

• Lactating or pregnant women