Hodgkin Lymphoma, Immune Checkpoint Inhibitor, Radiotherapy
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGImmune checkpoint inhibitor
concomitant administration of radiotherapy and immune checkpoint inhibitor
Sponsors
Ospedale Maggiore Di Trieste
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 of localized disease, bulky disease, other reasons). Concomitant radiotherapy means a treatment received during the administration of ICI, or during the 8 weeks that precede or follow the start or the end of the treatment with ICI
Exclusion criteria
* Having received a treatment with an ICI and radiotherapy not concomitant, according to 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 combination therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission (CR) rate measured according to Lugano and Lyric criteria by CT-PET (positron emission tomography / computer tomography) or CT (computer tomography) scan | up to 2 months after the end of ICI or 3 months after the end of RT |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate (ORR) measured according to Lugano and Lyric criteria by CT-PET or CT scan | up to 2 months after the end of ICI or 3 months after the end of RT |
| progression-free survival (PFS) measured according to Cheson 2007 response criteria | from the start of the treatment until the date of documented progression or date of death from any cause, assessed up to 5 years |
| safety profile assessed by monitoring adverse events (AEs) and serious adverse events (SAEs) according to CTCAE v. 4.0 | through study completion, for an average of 1 year |
Countries
Italy
Contacts
Primary ContactFrancesco Zaja, Professor
Outcome results
None listed