Immune Checkpoint Inhibitors and Radiotherapy in Relapsed/Refractory Hodgkin Lymphoma

N/AUnknownNCT04419441

Ospedale Maggiore Di Trieste12 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hodgkin Lymphoma Immune Checkpoint Inhibitor Radiotherapy

Interventions

Immune checkpoint inhibitorDRUG

concomitant administration of radiotherapy and immune checkpoint inhibitor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

SC Ematologia Ospedale Maggiore

Trieste, Italy

RECRUITING

Outcomes

Primary Outcomes

Complete remission (CR) rate measured according to Lugano and Lyric criteria by CT-PET (positron emission tomography / computer tomography) or CT (computer tomography) scan

Time frame: up to 2 months after the end of ICI or 3 months after the end of RT

Secondary Outcomes

overall response rate (ORR) measured according to Lugano and Lyric criteria by CT-PET or CT scan

Time frame: 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

Time frame: 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

Time frame: through study completion, for an average of 1 year

Central Contacts

Francesco Zaja, Professor

CONTACT

+390403992888 francesco.zaja@asugi.sanita.fvg.it

Data from ClinicalTrials.gov

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