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

September 14, 2020 updated by: Francesco Zaja, Ospedale Maggiore Di Trieste

Retrospective, Multicentric, Observational Study to Evaluate the Efficacy and Safety of the Combination of an Immune Checkpoint Inhibitor (ICI) and Radiotherapy (RT) in Patients With Relapsed/Refractory (R/R) Classical Hodgkin Lymphoma (cHL)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Trieste, Italy, 34100
        • Recruiting
        • SC Ematologia Ospedale Maggiore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population includes adult patients with relapsed/refractory Hodgkin lymphoma treated in referral centers for haematology

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
treated patients
patients with relapsed/refractory Hodgkin lymphoma who received a treatment with the combination of radiotherapy and an immune checkpoint inhibitor
Drug: Immune checkpoint inhibitor
concomitant administration of radiotherapy and immune checkpoint inhibitor
Other Names:
  • radiotherapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
through study completion, for an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Maggiore Di Trieste

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2020

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

September 30, 2020

Study Registration Dates

First Submitted

June 2, 2020

First Submitted That Met QC Criteria

June 4, 2020

First Posted (Actual)

June 5, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICI-RT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

it is not yet known if there will be a plan to make IPD available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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