Study Comparing ABVD vs BEACOPP in Advanced Hodgkin's Lymphoma

Launched by FONDAZIONE MICHELANGELO · Nov 30, 2010

Keywords

ClinConnect Summary

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, ...

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ALL

Eligibility 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