Imaging with a radioactively-labeled antibody against PDL-1 in patients with lymphoma

Phase 1

• Conditions: Diffuse large B-cell Lymphoma; MedDRA version: 20.0 Level: HLT Classification code 10012819 Term: Diffuse large B-cell lymphomas System Organ Class: 100000004851; MedDRA version: 20.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: LLT Classification code 10012820 Term: Diffuse large B-cell lymphoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2017-003511-20-NL
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-26
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

In order to receive information on the dynamics induced by R-CHOP, patients should preferably be included before standard R-CHOP therapy (at Part A). Alternatively, patients who are eligible can also be included after having achieved complete remission with standard R-CHOP therapy (i.e. at Part B).

Inclusion criteria
• Age 18-75 (inclusive) years
• Patients with a confirmed histologic diagnosis of diffuse large B-cell lymphoma (DLBCL-NOS) based upon a representative histology specimen according to the WHO classification, revision 2016 (see appendix A)
• Ann Arbor stages II-IV (see appendix B)
• WHO performance status 0 – 1 (see appendix E)
• IPI = 3 at diagnosis (see appendix C)
• Negative pregnancy test at study entry
• Patient is willing and able use adequate contraception during and until 5 months after the last protocol treatment.
• Written informed consent
• Patient is capable of giving a 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

Diagnosis
• All histopathological diagnoses other than DLBCL-NOS according to the WHO classification, revision 2016 (see appendix A), including:
- High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 translocations
- Testicular large B-cell lymphoma
- Primary mediastinal B cell lymphoma
- Transformed indolent lymphoma
- Post-transplant lymphoproliferative disorder

Organ dysfunction
• Clinical signs of severe pulmonary dysfunction
• Clinical signs of heart failure (NYHA classification II-IV)
• Symptomatic coronary artery disease or cardiac arrhythmias not well controlled with medication.
• Myocardial infarction during the last 6 months
• Significant renal dysfunction (serum creatinine = 150 umol/l or clearance = 30ml/min
Creatinine clearance may be calculated by Cockcroft –Gault formula:
CrCl = (140 - age [in years]) x weight [kg] (x 0.85 for females) /
(0.815 x serum creatinine [µmol/L])
• Inadequate hematological function: hemoglobin < 5.5 mmol/L ANC < 1.0x10^9/L or platelets < 75x10^9 /L
• Spontaneous INR > 1.5, aPTT >33
• Significant hepatic dysfunction (total bilirubin = 1.5x upper limit of normal (ULN) or transaminases = 2.5 x ULN), unless related to Gilberts syndrome.
• Clinical signs of severe cerebral dysfunction
• Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
• Major surgery within the last 4 weeks

Known or suspected infection
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks before date of registration. Suspected active or latent tuberculosis needs to be confirmed by positive interferon gamma (IFN-?) release assay
• Patients known to be HIV-positive
• Active chronic hepatitis B or C infection
• Administration of a live, attenuated vaccine within 4 weeks before date of registration or anticipation that such a live attenuated vaccine will be required during the study and for a period of 5 months after discontinuation of atezolizumab.

Auto-immune
• Any active or history of documented autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
The following exceptions are allowed: Patients with autoimmune-related hypothyroidism or type 1 diabetes mellitus who are on stable treatment.
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidenc

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified