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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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 (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue

• To analyse if patients achieving early complete response (PET-2 negative), can be spared the adjuvant radiotherapy on areas of initial bulky disease, at the end of the planned six courses of ABVD. To answer this question, PET-2 negative patients will be randomized between radiotherapy versus no radiotherapy at the end of ABVD therapy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Italiana Linfomi ONLUS
• Collaborator: Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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%).