Early salvage with high dose chemotherapy and stem cell transplantation in advanced stage Hodgkin?s lymphoma patients with positive positron emission tomography after two courses of ABVD (PET-2 positive) and comparison of radiotherapy versus no radiotherapy in PET-2 negative patients. - IIL HD 0801

• Conditions: HODGKIN LYMPHOMA; MedDRA version: 9.1Level: LLTClassification code 10020205Term: Hodgins

• Registration Number: EUCTR2008-002684-14-IT
• Lead Sponsor: IIL INTERGRUPPO ITALIANO LINFOMI ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-26
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Histologically confirmed diagnosis of Hodgkin?s lymphoma, with the exclusion of nodular lymphocyte predominance. - Age 18-70. - Stage IIB-IV. - No prior therapy. - ECOG performance status grades 0-3 (see Appendix 4) - FDG-PET scan performed before treatment. - Written Informed Consent.
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Age less than 18 or more than 70. - Prior therapy for Hodgkin?s lymphoma. - Other concomitant or prior malignancies, with the exception of basal cell skin carcinoma, of adequately treated carcinoma in situ of the cervix and of any cancer in complete remission for more than 5 years. - Pregnancy or breast-feeding. - Clinically significant cardiac disease, including congestive heart failure, that can contraindicate the treatment with anthracyclines (NYHA class ≥ 2 or FEV < 45%). - HIV infection. - Any other contraindication to ABVD, such as renal failure (creatinine level more than two times the normal value) or hepatic failure (AST/ALT or bilirubine more than 2.5 times the normal value). - Concomitant participation to a study in which investigational drugs are tested. - Absence of a written Informed Consent.

Study & Design

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