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RECRUITING
NCT04866654
PHASE2

Radiation Free Chemotherapy for Early Hodgkin Lymphoma

Sponsor: Medical University of Gdansk

View on ClinicalTrials.gov

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

Interventions

DRUG

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