Radio-Immunotherapy in MAlignant Lymphoma 1 (RIMAL1)

Phase 1

• Conditions: patients with recurrent / refractory 9p24.1 amplified malignant lymphomaspatients with recurrent / refractory malignant lymphoma without 9p24.1 amplification; MedDRA version: 20.0Level: PTClassification code 10025310Term: LymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-001270-34-NL
• Lead Sponsor: Radboud University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-08
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 clinical trial of medicinal product
• Study Design: Not specified