Programmed death ligand 1 (PD-L1) PET imaging in patients with (Diffuse) Large B-cell lymphoma who are treated with CD19-directed CAR T-cell therapy: a pilot study.

Phase 2

Recruiting

Conditions: Large B-cell lymphoma
lymphoma
10025320

Registration Number: NL-OMON56151

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Histologically confirmed LBCL and associated subtypes, defined by WHO 2016
classification
2. Eligibility for CAR T-cell therapy must be approved by the Dutch National
Tumor Board.
3. Measurable disease, as defined by Lugano criteria
4. Signed informed consent.
5. Age >=18 at the time of signing informed consent.
6. Ability to comply with the protocol.

Exclusion Criteria

1.Signs or symptoms of active infection within 2 weeks prior to
89Zr-atezolizumab injection, unless treated to resolution.
2.History of severe allergic, anaphylactic, or other hypersensitivity reactions
to chimeric or humanized antibodies or fusion proteins.
3.Any other diseases, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or
condition that contraindicates the use of 89Zr-atezolizumab, or that may affect
the interpretation of the results or render the patient at high risk from
complications.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary parameters<br /><br>- to study the expression of PD-L1 in normal tissue and lymphoma lesions before<br /><br>CD19-directed CAR T-cell therapy in LBCL patients by 89Zr-atezolizumab PET/CT<br /><br>imaging and to correlate pretreatment 89Zr-atezolizumab uptake to response to<br /><br>CD19-directed CAR T-cell therapy and thereby identify clinically relevant<br /><br>PD-L1 expression. Heterogeneity of 89Zr-atezolizumab uptake will be evaluated<br /><br>by measuring standardized uptake value (SUV) on the 89Zr-atezolizumab PET/CT<br /><br>scan.<br /><br>- To study whether the amount of 89Zr-atezolizumab uptake, measured by the<br /><br>intensity of 89Zr-atezolizumab PET/CT imaging (SUV), can be used to<br /><br>differentiate between lymphoma activity and treatment-related inflammatory<br /><br>reaction (histiocytic/sarcoid-like reaction) in patients with an<br /><br>end-of-treatment 18F-FDG-positive PET/CT signal. </p><br>

Secondary Outcome Measures