Immune Checkpoint Inhibitors and Radiotherapy in Relapsed/Refractory Hodgkin Lymphoma

• Conditions: Immune Checkpoint Inhibitor; Hodgkin Lymphoma; Radiotherapy
• Interventions: Drug: Immune checkpoint inhibitor

• Registration Number: NCT04419441
• Lead Sponsor: Ospedale Maggiore Di Trieste

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.

Study Timeline

• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-05
• Study Start: 2020-06-24
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
treated patients	Immune checkpoint inhibitor	patients with relapsed/refractory Hodgkin lymphoma who received a treatment with the combination of radiotherapy and an immune checkpoint inhibitor

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

SC Ematologia Ospedale Maggiore; 🇮🇹 Trieste, Italy