Immune Checkpoint Inhibitors and Radiotherapy in Relapsed/Refractory Hodgkin Lymphoma (ICI-RT-1)

Ospedale Maggiore Di Trieste

Status

Unknown

Conditions

Hodgkin Lymphoma

Immune Checkpoint Inhibitor

Radiotherapy

Treatments

Drug: Immune checkpoint inhibitor

Study type

Observational

Funder types

Other

Identifiers

NCT04419441

ICI-RT-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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