Status:
COMPLETED
High-dose Chemotherapy and Stem Cell Transplantation, in Patients PET-2 Positive, After 2 Courses of ABVD and Comparison of RT Versus no RT in PET-2 Negative Patients
Lead Sponsor:
Fondazione Italiana Linfomi - ETS
Collaborating Sponsors:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Conditions:
Hodgkin's Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to define an improvement in patients: * To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (P...
Detailed Description
This study is composed by two phases: 1. A phase II multi-centre study evaluating in patients with advanced stage Hodgkin lymphoma the efficacy of an early salvage treatment with high-dose chemothera...
Eligibility Criteria
Inclusion
- Histologically confirmed Hodgkin's lymphoma of the classical type (nodular lymphocyte predominance excluded).
- Stage IIB-IV.
- Age 18-70.
- No prior therapy for Hodgkin's lymphoma
- Written informed consent.
- ECOG performance status grades 0-3 (see Appendix E).
- FDG-PET scan before the initiation of treatment.
Exclusion
- Prior therapy for Hodgkin's lymphoma.
- Age less than 18 or more than 70.
- Other concomitant or prior malignancies, except basal cell skin carcinoma, or adequately treated carcinoma in situ of the cervix, or any cancer in complete remission for more than 5 years.
- HIV infection.
- Pregnancy or breast-feeding.
- Renal failure (creatinine ≥2 times the normal value), liver failure (AST/ALT or bilirubine ≥ 2.5 times the normal value) or heart failure (NYHA class ≥ 2 or FEV \< 45%).
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT00784537
Start Date
September 1 2008
End Date
January 1 2016
Last Update
February 8 2018
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
Centro di riferimento Oncologico Oncologia Medica A
Aviano, Italy
2
Università Policlinico di Bari - Divisione di Medicina A
Bari, Italy
3
Policlinco Sant'Orsola Isituto di Ematologia ed oncologia Medica
Bologna, Italy
4
Sezione di Ematologia Spedali Civili
Brescia, Italy