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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Nivolumab, 100 mg, 10 mg/ml
Hematology Department IRCCS Policlinico San Matteo
Pavia, P.le Golgi 19, Italy
RECRUITINGOspedale Papa Giovanni XXIII
Bergamo, Piazza OMS, 1, Italy
NOT_YET_RECRUITINGIstituto Europeo di Oncologia
Milan, Via Giuseppe Ripamonti 435, Italy
NOT_YET_RECRUITINGHematology Department Azienda Ospedaliera S. Croce e Carle
Cuneo, Via Michele Coppino, 26, Italy
Efficacy exploration in terms of 3-Y PFS of chemotherapy alone
To explore the efficacy, in terms of 3-Y PFS of chemotherapy alone in low-risk early-stage I-IIA HL patients, defined by both a low MTV and a negative interim PET after 2 courses of ABVD
Time frame: During follow-up (36 months) after the end of treatment
Efficacy exploration in terms of 3-Y PFS of chemotherapy plus Nivolumab
To explore the efficacy in terms of 3-Y PFS of CMT plus Nivolumab in high-risk early-stage (I-IIA) HL (eHL), defined either by a positive PET- 2 or a high baseline MTV or both
Time frame: During follow-up (36 months) after the end of treatment
Efficacy exploration in terms of 3-Y freedom from 2nd treatment failure (3-Y FF2TF) of chemotherapy followed by radiotherapy "on demand" plus Nivolumab maintenance
To explore the efficacy in terms of 3-Y freedom from 2nd treatment failure (3-Y FF2TF) of chemotherapy followed by radiotherapy "on demand" plus Nivolumab maintenance in patients relapsing with the pattern of "limited relapse" (see below) for the entire group (relapsed and non-relapsed) of low-risk patients (with low MTV and negative PET- 2) high-risk early-stage (I-IIA) HL (eHL), defined either by a positive PET- 2 or a high baseline MTV or both
Time frame: During follow-up (36 months) after the end of treatment
Safety exploration in terms of 3-Y OS of a treatment with chemotherapy alone
To explore the safety in terms of 3-Y OS of a treatment with chemotherapy alone in low-risk early-stage (I-IIA) HL patients, defined by a low Metabolic Tumor Volume negative interim PET after 2 ABVD courses
Time frame: During follow-up (36 months) after the end of treatment
Evaluation the ability of cell-free DNA (cfDNA) assay
To evaluate the ability of cell-free DNA (cfDNA) assay to detect an impending relapse during follow-up in low-risk patients treated with chemotherapy alone�k�
Time frame: During follow-up (36 months) after the end of treatment
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Azienda Ospedaliera Universitaria Policlinico Federico II
Naples, Via S.Pansini, 5, Italy
RECRUITINGIRCCS Istituto Tumori Giovanni Paolo II
Bari, Viale Orazio Flacco, 65, Italy
NOT_YET_RECRUITINGPoliclinico Università Tor Vergata
Roma, Viale Oxford, 81, Italy
NOT_YET_RECRUITINGAzienda Ospedaliero - Universitaria Ospedali Riuniti
Ancona, Italy
NOT_YET_RECRUITINGAzienda Ospedaliera G. Brotzu - Ospedale Businco
Cagliari, Italy
NOT_YET_RECRUITINGDivisione Universitaria di Onco-Ematologia
Monza, Italy
NOT_YET_RECRUITING...and 17 more locations