Status:
COMPLETED
Study Comparing ABVD vs BEACOPP in Advanced Hodgkin's Lymphoma
Lead Sponsor:
Fondazione Michelangelo
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
17-60 years
Phase:
PHASE3
Brief 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, ...
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 durabl...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT01251107
Start Date
March 1 2000
End Date
November 1 2009
Last Update
August 13 2015
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale di Tumori di Milano
Milan, Italy