A phase II study about the use of intensified hybrid chemotherapy regimen ChLVVP/ABVVP in advanced Hodgkin lymphoma patients. - ND

• Conditions: Hodgkin s disease; MedDRA version: 9.1Level: HLTClassification code 10020243Term: Hodgkin's disease NEC

• Registration Number: EUCTR2006-005004-14-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Hystologically proven diagnosis of Hodgkin disease, according to WHO classification 2.Stage IA, IB, IIA, IIB with one of the following risk factors bulky disease defined as a mediastinal mass 8805; 1/3 maximum transverse thorax diameter or any lesion 8805; 5 cm extranodal involvement ESR 8805; 50 A ; 8805; 30 B 3 or more lymph node regions involved 3.Stage III, IV 4.Performance status ECOG 61603; 2 5.Written informed consent 6.Age 61619;18 yrs and 61603; 65 yrs
Are the trial subjects under 18? no
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

1.Previous chemotherapy and or radiotherapy for Hodgkin disease 2.Any other malignancy or history of prior malignancy except non-melanoma skin tumours or in situ cervical carcinoma 3.Chronic disease uncontrolled by therapy 4.HIV positivity 5.Abnormal blood count ANC 1.5 x 109/L, platelet count 150 x 109/L, Hob 9 g/dl due to other causes than Hodgkin disease 6.Abnormal renal function serum creatinine 2.5 x ULN due to other causes than Hodgkin disease 7.Abnormal liver function total bilirubin 1.5 x ULN, transaminase 2.5 x ULN due to other causes than Hodgkin disease 8.Pregnancy and/or lactation 9.Patients with a history of psychiatric illness or condition which could interfere with their ability to understand the requirements of the study 10.Patients unwilling or unable to comply with the protocol

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: primary endpoint of this study is to reach a progression free survival PFS at three years greater than 80 ;Secondary Objective: - Overall survival time from start of treatment to death for any cause at three years - Haematological and non haematological toxicity; - Need for transfusions support - Time to recycle - Incidence of severe infectious event - Late toxicity;Primary end point(s): progression free survival PFS at three years