Trials / Unknown
UnknownNCT04419441
Immune Checkpoint Inhibitors and Radiotherapy in Relapsed/Refractory Hodgkin Lymphoma
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)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 12 (estimated)
- Sponsor
- Ospedale Maggiore Di Trieste · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Immune checkpoint inhibitor | concomitant administration of radiotherapy and immune checkpoint inhibitor |
Timeline
- Start date
- 2020-06-24
- Primary completion
- 2020-09-30
- Completion
- 2020-09-30
- First posted
- 2020-06-05
- Last updated
- 2020-09-16
Locations
1 site across 1 country: Italy
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04419441. Inclusion in this directory is not an endorsement.