Radiation Free Chemotherapy for Early Hodgkin Lymphoma

Sponsor
Medical University of Gdansk
Study ID
NCT04866654
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 4, 2021
Status verified
Aug 2021
Primary completion
Sep 30, 2022
Completion
Jul 2, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study group
    Nivolumab, total dose 5760 mg milligram

Primary Outcome Measure

Efficacy exploration in terms of 3-Y PFS of chemotherapy alone [ Time Frame: During follow-up (36 months) after the end of treatment ]

Central Contacts

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