A phase II study evaluating the feasibility and clinical efficacy of atezolizumab consolidation treatment in high risk diffuse large B-cell lymphoma.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 109

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
• Ann Arbor stages II-IV
• WHO performance status 0 – 1
• IPI >=3 at diagnosis
• Complete metabolic remission (Deauville 1-3) after 6-8 cycles of R-CHOP according to the Lugano criteria
• Negative pregnancy test at study entry
• Patient is willing and able use adequate contraception during and until 6 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 67
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

Diagnosis
• All histopathological diagnoses other than DLBCL-NOS according to the WHO classification, revision 2016,including:
-High-grade B-cell lymphoma with a double/triple translocation with MYC, BCL2 and/or BCL6. Please note that patients with an isolated MYC
translocation or an isolated BCL2 translocation or an isolated BCL-6 translocation are eligible (single hit translocation).
-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.
•Inadequate hematological function: hemoglobin < 5.5 mmol/L , ANC < 1.0x109/L or platelets < 75x109 /L
•Signs or known history of bleeding disorder
•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 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 evidence of active pneumonitis per chest CT scan at screening.
• Patients with uncontrolled asthma or allergy, requiring systemic steroid treatment
• Regular treatment with corticosteroids within the 4 weeks prior to date of registration, unless administered for indications other than NHL at a dose equivalent to < 30 mg/day prednison

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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