Clinical trial NCT00784537: 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
Official title: Early Salvage With High Dose Chemotherapy and Stem Cell Transplantation in Advanced Stage Hodgkin's Lymphoma Patients With Positive PET After Two Courses of ABVD (PET-2 Positive) and Comparison of RT Versus no RT in PET-2 Negative Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hodgkin's Lymphoma
Keywords: Hodgkin's lymphoma
ABVD
FDG-PET (18-Fluoro-deoxy-D-glucose Positron Emission Tomography)
Radiotherapy
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
Collaborators: name: Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
First posted: 2008-11-04
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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%).

Primary outcomes:
measure: 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.
timeFrame: 4 years
Secondary outcomes:
measure: 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.
timeFrame: 4 years
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di riferimento Oncologico Oncologia Medica A
city: Bari
country: Italy
facility: Università Policlinico di Bari - Divisione di Medicina A
city: Bologna
country: Italy
facility: Policlinco Sant'Orsola Isituto di Ematologia ed oncologia Medica
city: Brescia
country: Italy
facility: Sezione di Ematologia Spedali Civili
city: Busto Arsizio
country: Italy
facility: Ospedale di Circolo SC Oncologia Medica III
city: Cagliari
country: Italy
facility: Divisione di Ematologia Osp.Businco
city: Firenze
country: Italy
facility: Policlinico Careggi Cattedra di Ematologia
city: Ivrea
country: Italy
facility: ASLTO4
city: Lecce
country: Italy
facility: Osp. Cardinale Panico Divisione di Ematologia Tricase
city: Milano
country: Italy
facility: Ospedale Niguarda Cà Granda
city: Novara
country: Italy
facility: Università Avogadro Divisione di Ematologia
city: Nuoro
country: Italy
facility: Ospedale San Francesco UO Ematologia e Centro Trapianti
city: Pavia
country: Italy
facility: Fondazione Policlinico San Matteo Clinica Ematologica
city: Ravenna
country: Italy
facility: Osp. Santa Maria delle Croci UO Ematologia
city: Reggio Calabria
country: Italy
facility: Ospedale Bianchi Melacrino Morelli
city: Rimini
country: Italy
facility: Osp. degli Infermi Divisione di Oncologia
city: Roma
country: Italy
facility: Istituto Regina Elena IFO SC Ematologia
city: Roma
country: Italy
facility: Osp.Sant'Eugenio Divisione di Ematologia
city: Roma
country: Italy
facility: Università La Sapienza Dipartimento di Biotecnnologie Cellulari
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas Divisione di Oncologia Medica ed Ematologia
city: Sassari
country: Italy
facility: AO Universitaria di Sassari
city: Siena
country: Italy
facility: Policlinico Le Scotte
city: Terni
country: Italy
facility: Struttura Complessa di Onco-Ematologia
city: Torino
country: Italy
facility: IRCC Onco-Ematologia Candiolo
city: Torino
country: Italy
facility: Osp. San Giovanni Battista_Molinette Ematologia 2
city: Udine
country: Italy
facility: Azienda Ospedaliero universitaria di Udine
city: Verbania
country: Italy
facility: ASL 14 UO Oncologia
Study officials:
affiliation: Ospedale SS. Antonio, Biagio e Cesare Arrigo
name: Alessandro Levis, MD
role: STUDY_DIRECTOR
References:
citation: Ricardi U, Levis M, Evangelista A, Gioia DM, Sacchetti GM, Gotti M, Re A, Buglione M, Pavone V, Nardella A, Nassi L, Zanni M, Franzone P, Frezza GP, Pulsoni A, Grapulin L, Santoro A, Rigacci L, Simontacchi G, Tani M, Zaja F, Abruzzese E, Botto B, Zilioli VR, Rota-Scalabrini D, Freilone R, Ciccone G, Filippi AR, Zinzani PL. Role of radiotherapy to bulky sites of advanced Hodgkin lymphoma treated with ABVD: final results of FIL HD0801 trial. Blood Adv. 2021 Nov 9;5(21):4504-4514. doi: 10.1182/bloodadvances.2021005150.
citation: Zinzani PL, Broccoli A, Gioia DM, Castagnoli A, Ciccone G, Evangelista A, Santoro A, Ricardi U, Bonfichi M, Brusamolino E, Rossi G, Anastasia A, Zaja F, Vitolo U, Pavone V, Pulsoni A, Rigacci L, Gaidano G, Stelitano C, Salvi F, Rusconi C, Tani M, Freilone R, Pregno P, Borsatti E, Sacchetti GM, Argnani L, Levis A. Interim Positron Emission Tomography Response-Adapted Therapy in Advanced-Stage Hodgkin Lymphoma: Final Results of the Phase II Part of the HD0801 Study. J Clin Oncol. 2016 Apr 20;34(12):1376-85. doi: 10.1200/JCO.2015.63.0699. Epub 2016 Feb 16.