Enhancement of immune response by combining immune checkpoint blockade and radiation in patients with recurrent / refractory malignant lymphoma (re-directing the immune system).

Withdrawn

• Conditions: malignant lymphoma; lymph node cancer; 10025323

• Registration Number: NL-OMON50953
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- patients with refractory / recurrent malignant lymphoma eligible for ICB
therapy
- aged 18 - 75 year
- WHO score >=2
- adequate organ function
neutrophil count
serum creatinine
ASAT, ALAT
albumin
- 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
<p>Enhancement of the immune response by radiation, and thereby treatment<br /><br>efficacy, in patients with recurrent / refractory malignant lymphomas treated<br /><br>with immune checkpoint blockade (ICB). As a measure for immune activation,<br /><br>interferon I and II signature alterations will be correlated with clinical<br /><br>response measured by [18F]FDG PET-CT scans and the amount of circulating tumour<br /><br>DNA (ctDNA). </p><br>