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

Fondazione Italiana Linfomi - ETS520 enrolled

Overview

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.

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 chemotherapy followed by stem cell transplantation in patients FDG-PET positive after two courses of ABVD (PET-2 positive). 2. A phase III randomised study comparing the efficacy of radiotherapy to the areas of initial bulky disease versus no further therapy in PET-2 negative patients in complete remission (PET-6 negative) at the end of six courses of ABVD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

520

Conditions

Hodgkin's Lymphoma

ABVDDRUG

ABVD courses are scheduled every 28 days: Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15 ABVD courses are scheduled every 28 days: Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15 Randomization to Arm A (Observation)

ABVD and RadiotherapyDRUG

ABVD courses are scheduled every 28 days: Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15 Randomization to Arm B, Radiotherapy, in patients in CR, on the area of initial bulky disease (see above for the definition of nodal and/or mediastinal bulk).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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%).

Locations (27)

Centro di riferimento Oncologico Oncologia Medica A

Aviano, Italy

Università Policlinico di Bari - Divisione di Medicina A

Bari, Italy

Policlinco Sant'Orsola Isituto di Ematologia ed oncologia Medica

Bologna, Italy

Sezione di Ematologia Spedali Civili

Brescia, Italy

Ospedale di Circolo SC Oncologia Medica III

Busto Arsizio, Italy

Divisione di Ematologia Osp.Businco

Cagliari, Italy

Policlinico Careggi Cattedra di Ematologia

Florence, Italy

ASLTO4

Ivrea, Italy

Osp. Cardinale Panico Divisione di Ematologia Tricase

Lecce, Italy

Ospedale Niguarda Cà Granda

Milan, Italy

...and 17 more locations

Outcomes

Primary Outcomes

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.

Time frame: 4 years

Secondary Outcomes

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.