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Radiation Free Chemotherapy for Early Hodgkin Lymphoma
Sponsor: Medical University of Gdansk
Summary
The results of the present study will provide information on short-term safety and efficacy of a iPET and MTV-adapted therapeutic strategy, aimed to assess the feasibility and safety on immediate disease control of a standard ABVD chemotherapy without any further treatment in patients with a very low risk or treatment failure. A second very important endpoint will be the efficacy of INRT "on demand" followed by Nivolumab maintenance for one year to rescue patients failing first-line treatment and relapsing with the pattern of "limited relapse" in terms of 3-Y failure from 2 relapse (FF2R). Patients entering into the study will be also asked to participate to a long-term follow up study (beyond ten years) to assess the prevalence of late-onset cardiovascular effects and secondary tumors in the cohort of patients enrolled in the experimental and control arm of the study. An exploratory endpoint has been also added such as the role of Minimal Residual Disease (MRD) detection by cell-free DNA assay on peripheral blood samples obtained during treatment in predicting long-term disease control.
Official title: Radiation-Free Therapy for the Initial Treatment of Good Prognosis Early Non-bulky HL, Defined by a Low Metabolic Tumor Volume and a Negative Interim PET After 2 Chemotherapy Cycles- RAFTING
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2021-03-04
Completion Date
2026-07-02
Last Updated
2021-08-12
Healthy Volunteers
No
Conditions
Interventions
Nivolumab 10 MG/ML
Nivolumab, 100 mg, 10 mg/ml
Locations (27)
Hematology Department IRCCS Policlinico San Matteo
Pavia, P.le Golgi 19, Italy
Ospedale Papa Giovanni XXIII
Bergamo, Piazza OMS, 1, Italy
Istituto Europeo di Oncologia
Milan, Via Giuseppe Ripamonti 435, Italy
Hematology Department Azienda Ospedaliera S. Croce e Carle
Cuneo, Via Michele Coppino, 26, Italy
Azienda Ospedaliera Universitaria Policlinico Federico II
Naples, Via S.Pansini, 5, Italy
IRCCS Istituto Tumori Giovanni Paolo II
Bari, Viale Orazio Flacco, 65, Italy
Policlinico Università Tor Vergata
Roma, Viale Oxford, 81, Italy
Azienda Ospedaliero - Universitaria Ospedali Riuniti
Ancona, Italy
Azienda Ospedaliera G. Brotzu - Ospedale Businco
Cagliari, Italy
Divisione Universitaria di Onco-Ematologia
Monza, Italy
Azienda Ospedaliera di Padova Dipartimento di Medicina Interna
Padova, Italy
Ospedali Riuniti Villa Sofia
Palermo, Italy
Gdański Uniwersytet Medyczny Department of Hematology and Transplantology
Gdansk, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Poland
Instytut Hematologii i Transfuzjologii ul. Indiry Gandhi 14 02-776 Warszawa
Warsaw, Poland
Uniwersyteckie Centrum Kliniczne im. Jana Mikulicza- Radeckiego we Wrocławiu
Wroclaw, Poland
Hospital Universitario Central de Asturias
Oviedo, Av. Roma, Spain
Hospital Universitario 12 de Octubre
Madrid, Avda de Córdoba, Spain
Hospital Duran i Reynals. Institut Catala d'Oncologia
Barcelona, Avinguda de La Granvia de l'Hospitalet, 199-203, Spain
Hospital Germans Trias i Pujol-ICO Badalona
Carretera de Canyet, Barcelona, Spain
Hospital Universitario Vall d'Hebron
Passeig de La Vall d'Hebron, 119-129, Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, C. de Villarroel, 170, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Calle Del Dr. Esquerdo, Spain
Hospital Universitario Marques de Valdecilla
Av. de Valdecilla, 25, Cantabria, Spain
Hospital Universitario Ramón y Cajal
Madrid, Ctra. de Colmenar Viejo Km. 9,100, Spain
Hospital Universitario de Salamanca
Salamanca, P.º de San Vicente, 58, Spain
Hospital Universitario Virgen del Rocio
Av. Manuel Siurot, Sevilla, Spain