BEACOPP (4 cycles escalated + 4 cycles baseline) versus ABVD (8 cycles) in stage III & IV Hodgkin’s lymphoma

• Conditions: Hodgkin's Lymphoma; MedDRA version: 8.1Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's disease

• Registration Number: EUCTR2004-001558-10-CZ
• Lead Sponsor: European Organisation for Research and Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-28
• Last Update Posted: 2 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

- Histologically documented Hodgkin’s lymphoma/disease, except for the subtype lymphocyte predominant, nodular type (nodular paragranuloma)
- Clinical stage III or IV
- Presence of at least one bi-dimensionally measurable target lesion ; patients with extranodal disease only will be eligible if they have at least one bi-dimensionally measurable extranodal lesion.
- Patients with an International Prognostic Score (IPS) ?3
- Age 16-60 years
- WHO performance status grades 0, 1, or 2
- Adequate liver (bilirubin = 2.5 x normal) and renal (creatinine = 150 ?mol/L or = 2.0 mg/dL) function, unless abnormalities are due to HD
- Leukocytes >2.0*109/l and platelets >100*109/l

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients with no nodal or visceral measurable disease.
- Prior therapy for Hodgkin's disease
- Potentially childbearing patients without effective contraception
- Pregnant or lactating women
- Concomitant or previous malignancies other than basal cell skin tumors or in situ uterine cervix carcinoma
- Severe cardio-pulmonary, neurological or metabolic disease, interfering with normal life expectancy or normal application of protocol treatment (patients with LEVF<50 and RF<30% are not eligible)
- Severe active infection
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Known HIV or HTLV1 positivity
- History of uncontrolled HBV infection defined as presence of HBS antigen or absence of HBS antigen but presence of anti-HBc antibody without anti-HBS antibody

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified