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
- Conditions
- Hodgkin's Lymphoma
- Interventions
- Drug: ABVDDrug: ABVD and Radiotherapy
- Registration Number
- NCT00784537
- Lead Sponsor
- Fondazione Italiana Linfomi - ETS
- 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 (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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 520
- 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.
- 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%).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A ABVD Two courses of ABVD. Early restaging with FDG-PET scan (PET-2) The subsequent treatment will be as it follows: * PET-2 positive patients will be high-dose salvage treatment; * PET-2 negative patients will be treated with four additional courses of ABVD (for a total of six courses). The following restaging procedures are planned as it follows: * Optional: Whole body CT scan after the fourth course of ABVD; no therapy change will be made according to CT scan. * Mandatory: Whole body CT and FDG-PET scans after the sixth course of ABVD (PET-6). PET-6 negative patients will be randomized to first arm: No radiotherapy. Arm B ABVD and Radiotherapy Two courses of ABVD. Early restaging with FDG-PET scan (PET-2) The subsequent treatment will be as it follows: * PET-2 positive patients will be high-dose salvage treatment; * PET-2 negative patients will be treated with four additional courses of ABVD (for a total of six courses). The following restaging procedures are planned as it follows: * Optional: Whole body CT scan after the fourth course of ABVD; no therapy change will be made according to CT scan. * Mandatory: Whole body CT and FDG-PET scans after the sixth course of ABVD (PET-6). PET-6 negative patients will be randomized to second arm: Adjuvant radiotherapy (30 Gy) on sites of initial bulky disease.
- Primary Outcome Measures
Name Time Method 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. 4 years
- Secondary Outcome Measures
Name Time Method 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. 4 years
Trial Locations
- Locations (27)
Sezione di Ematologia Spedali Civili
🇮🇹Brescia, Italy
Policlinco Sant'Orsola Isituto di Ematologia ed oncologia Medica
🇮🇹Bologna, Italy
Università Policlinico di Bari - Divisione di Medicina A
🇮🇹Bari, Italy
Osp. degli Infermi Divisione di Oncologia
🇮🇹Rimini, Italy
ASL 14 UO Oncologia
🇮🇹Verbania, Italy
Centro di riferimento Oncologico Oncologia Medica A
🇮🇹Aviano, Italy
Ospedale di Circolo SC Oncologia Medica III
🇮🇹Busto Arsizio, Italy
Divisione di Ematologia Osp.Businco
🇮🇹Cagliari, Italy
Ospedale Niguarda CÃ Granda
🇮🇹Milano, Italy
ASLTO4
🇮🇹Ivrea, Italy
Policlinico Careggi Cattedra di Ematologia
🇮🇹Firenze, Italy
Osp. Cardinale Panico Divisione di Ematologia Tricase
🇮🇹Lecce, Italy
Università Avogadro Divisione di Ematologia
🇮🇹Novara, Italy
Fondazione Policlinico San Matteo Clinica Ematologica
🇮🇹Pavia, Italy
Ospedale San Francesco UO Ematologia e Centro Trapianti
🇮🇹Nuoro, Italy
Osp. Santa Maria delle Croci UO Ematologia
🇮🇹Ravenna, Italy
Ospedale Bianchi Melacrino Morelli
🇮🇹Reggio Calabria, Italy
Istituto Regina Elena IFO SC Ematologia
🇮🇹Roma, Italy
Osp.Sant'Eugenio Divisione di Ematologia
🇮🇹Roma, Italy
Università La Sapienza Dipartimento di Biotecnnologie Cellulari
🇮🇹Roma, Italy
Istituto Clinico Humanitas Divisione di Oncologia Medica ed Ematologia
🇮🇹Rozzano (MI), Italy
AO Universitaria di Sassari
🇮🇹Sassari, Italy
Policlinico Le Scotte
🇮🇹Siena, Italy
Struttura Complessa di Onco-Ematologia
🇮🇹Terni, Italy
Osp. San Giovanni Battista_Molinette Ematologia 2
🇮🇹Torino, Italy
IRCC Onco-Ematologia Candiolo
🇮🇹Torino, Italy
Azienda Ospedaliero universitaria di Udine
🇮🇹Udine, Italy