Immune Checkpoint Inhibitors and Radiotherapy in Relapsed/Refractory Hodgkin Lymphoma

Last updated: September 14, 2020
Sponsor: Ospedale Maggiore Di Trieste
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer Treatment

Cancer

Lymphoma

Treatment

N/A

Clinical Study ID

NCT04419441
ICI-RT-01
  • Ages > 18
  • All Genders

Study Summary

This is an observational retrospective study to investigate the efficacy and safety of the treatment with an immune checkpoint inhibitor (nivolumab or pembrolizumab) in combination with radiotherapy in patients with relapsed/refractory classical Hodgkin lymphoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age ≥18 years

  • diagnosis of classical Hodgkin lymphoma, treated with one immune checkpoint inhibitor (ICI) (nivolumab or pembrolizumab), as per label indication

  • having received a concomitant radiotherapy, as per clinical need (persistence oflocalized disease, bulky disease, other reasons). "Concomitant" radiotherapy means atreatment received during the administration of ICI, or during the 8 weeks thatprecede or follow the start or the end of the treatment with ICI

Exclusion

Exclusion Criteria:

  • Having received a treatment with an ICI and radiotherapy not "concomitant", accordingto the abovementioned definition

  • Having received any other anti-lymphoma treatments during the same period of time

  • Patients who have not been evaluated by CT-PET or CT at the end of the combinationtherapy

Study Design

Total Participants: 12
Study Start date:
June 24, 2020
Estimated Completion Date:
September 30, 2020

Study Description

In patients with relapsed/refractory Hodgkin lymphoma, treatment with immune checkpoint inhibitors (ICIs), nivolumab and pembrolizumab, leads to 20-30% of complete remission (CR) rate. This means that for the majority of patients a consolidation strategy is usually offered, in order to reduce relapse rate.

Strategies to improve CR rates should therefore be implemented, including combination treatments. In solid tumors, the combination of ICIs and radiotherapy led to higher response rates without mjor toxicity concerns. Radiotherapy is an effective therapeutic option already used in Hodgkin lymphoma patients, also in the setting of relapsed/refractory disease. In his observational study we aim to evaluate the efficacy and safety of ICIs and radiotherapy administered in combination in patients with relapsed/refractory Hodgkin lymphoma.

Connect with a study center

  • SC Ematologia Ospedale Maggiore

    Trieste, 34100
    Italy

    Active - Recruiting

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