Hodgkin Lymphoma
Conditions
Keywords
Early Stage, Favorable, Classical, classical Hodgkin lymphoma (cHL)
Brief summary
The primary objective is to estimate the efficacy of experimental treatment with the anti-PD-1 antibody cemiplimab (REGN2810) in combination with simultaneous or subsequent radiotherapy (RT) in early-stage favorable classical Hodgkin lymphoma (cHL). Secondary objectives are to assess the safety and feasibility of the 2 experimental strategies.
Interventions
DRUGCemiplimab
Administered in 3-week intervals
RADIATIONInvolved-site radiotherapy (IS-RT)
Patients will receive IS-RT with a dose of 20 Gy. Involved-site radiotherapy will be carried out on the basis of 3D imaging as described in the protocol
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Histologically proven classical HL * First diagnosis, no previous treatment * Stage I-II without risk factors as defined in the protocol Key
Exclusion criteria
* Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) * Prior malignancy within the previous 5 years (except for locally treatable cancers that have been apparently cured by complete resection) * Prior chemotherapy or radiation therapy * Concurrent disease precluding protocol treatment as defined in the protocol * Pregnancy or breast-feeding * Non-compliance as defined in the protocol Note: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) at 1 year | From randomization up to 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) at 1, 2, and 3 years | From randomization up to 3 years | — |
| Incidence of acute toxicities | Up to 90 days after study treatment | — |
| Rate of patients with long-term fatigue using EORTC-QLQ-FA12 | 12-18 months after randomization | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ). -FA12 module complements the core EORTC QLQ-C30 questionnaire regarding fatigue. Each item can be scored in four dimension on a scale from 1 to 4 with higher scores indicating worse symptoms. |
| Rate of patients with long-term fatigue using EORTC-QLQ-C30 | 12-18 months after randomization | Scores range from 0 to 100. A high scale score represents a higher response level. |
| PFS at 2 and 3 years | From randomization up to 3 years | — |
| Rate of early discontinuation of study treatment | From first dose to up to 19 weeks | — |
| Frequency of lymphoma treatment administered in addition to study treatment | From randomization up to 3 years | — |
| Types of lymphoma treatment administered in addition to study treatment | From randomization up to 3 years | — |
| Quality of life (QoL) using EORTC-QLQ-30 | Up to 3 years | Scores range from 0 to 100. A high scale score represents a higher response level. |
Outcome results
None listed