Radio-Immunotherapy in MAlignant Lymphoma 1

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

patients with refractory / recurrent malignant lymphoma eligible for immune checkpoint blockade therapy
- aged 18 – 75 year
- WHO score =2
- adequate organ function
- no prior treatment with checkpoint inhibitors
- no non-infectious pneumonitis requiring steroids
- not pregnant
- patients of childbearing / reproductive potential should use 2 birth control methods
- written informed consent

Exclusion Criteria

- Not fit (mentally or physically) to undergo the proposed treatment.
- Patients with connective tissue diseases (inflammatory myopathy (polymyositis and ermatomyositis), systemic lupus erythematosus, Sjögren syndrome, systemic sclerosis, antisynthetase syndrome, rheumatoid arthritis, severe psoriasis and mixed CTDs), vasculitis (granulomatosis with polyangiitis (Wegener’s granulomatosis), microscopic polyangiitis, eosinophilic granulomatosis with polyangiitis (Churg–Strauss syndrome), severe Behçet disease, Takayasu arteritis, giant cell arteritis, Buerger disease, Kawasaki disease, polyarteritis nodosa, severe immunoglobulin A (IgA) vasculitis (Henoch–Schönlein purpura), severe cutaneous vasculitis, polymyalgia rheumatica, severe cryoglobulinaemia and undifferentiated systemic vasculitis) and other autoimmune diseases (primary biliary cirrhosis, severe autoimmune hepatitis, multiple sclerosis, severe antiphospholipid syndrome, myasthenia gravis, Guillain–Barré syndrome, inflammatory bowel disease, Miller–Fisher syndrome, Vogt–Koyanagi–Harada syndrome, eosinophilic fasciitis (Shulman syndrome), relapsing polychondritis and severe autoinflammatory diseases) ( Martins et al. 2019).
- Sensory or motor peripheral neuropathy > grade 2.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alteration / increase in interferon I and II (INF I and II) signatures in blood, measured 3 weeks after radiotherapy and after every 3 consecutive courses of immune checkpoint blockade. It is anticipated that the addition of radiotherapy will lead to an extra / more pronounced response.

Secondary Outcome Measures

Name	Time	Method
-[18F]FDG PET-CT response 3 weeks after radiotherapy and after every 3 consecutive courses of ICB, related to the presence of 9p24.1 amplification. It is expected that lymphomas that harbour a 9p24.1 amplification and therefore an overexpression of PD-L1 will be more sensitive to (radio-) ICB therapy resulting in a more pronounced response.<br>-Changes in ctDNA, based on the presence of tumour-specific somatic genomic characterizations of the lymphoma; reflecting lymphoma activity or tumour cell death, measured 3 weeks after radiotherapy and after every 3 consecutive courses of ICB. After an initial increase, a larger decrease in ctDNA is expected in the irradiated group.<br>

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