Clinical trial · Observational
BMS_PD-L1_onco : Assessment of the PD-L1 Protein as a Biomarker in Oncology and Hematology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Diffuse large B-cell lymphomas (DLBCLs) represent 25 to 30% of adult non-Hodgkin lymphomas in western countries. DLBCLs are aggressive cancer but potentially curable with multi-agent chemotherapy. Whereas R-CHOP regimen has led to a marked improvement in survival, this disease remains a biologically heterogeneous entity. New therapeutic strategies are required including identification of patients' subgroups with different prognostic. This project is based on BMS\_LyTrans and Goelams 075 clinical trial. A study of whole blood transcriptome in 75 DLBCL patients and in 87 controls showed that PD-L1 (CD274) gene was overexpressed in DLBCL patients. Preliminary results demonstrated that PD-L1 is detected in plasma of DLBCL patients with a significantly higher concentration than in controls. This protein was selected as a potential biomarker because of its established role in anti-tumoral immunity. Interaction between PD-L1 and its receptor PD-1 is known to inhibit activation of immune responses by inducing T-lymphocytes anergy and/or apoptosis. Moreover, a direct involvement of PD-L1 in the protection of cancer cells from lysis by activated T lymphocytes has been demonstrated. PD-L1 expression has been described in several solid tumours, including ovary cancer, breast cancer, colon cancer, renal cell carcinoma, non-small cell lung carcinoma and in hematological malignancies such as T-NHL, MM and Hodgkin's lymphoma. Furthermore the expression of PD-L1 by tumour cells is associated with poor prognosis. The blockade of PD-L1/PD-1 axis may represent a novel therapeutic approach in aggressive cancers. These first results incite to identify the cells releasing soluble PD-L1 and to investigate its role in the anti-tumoral immunity in DLBCL patients. The aim of this study is to identify cells producing soluble PD-L1 in DLBCL patients at diagnosis in comparison to others tumours known to express PD-L1 (metastatic breast cancer, Hodgkin's lymphoma, non-small cell lung cancer).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Metastatic Breastcancer | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (6)
- label
- DLBCL (diffuse large B-cell lymphoma)
- description
- DLBCL (diffuse large B-cell lymphoma)
- label
- Hodgkin's lymphoma
- description
- Hodgkin's lymphoma
- label
- metastatic breast cancer
- description
- metastatic breast cancer or with lymph node involvement
- label
- immune thrombocytopenia (ITP)
- description
- immune thrombocytopenia (ITP)
- label
- healthy volunteers
- description
- healthy volunteers
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: General inclusion criteria : * Age ≥ 18 years and ≤ 75 years, * Life expectancy more than 4 months * Signed informed consent obtained * Social security affiliation is mandatory * Non previously treated (even by corticotherapy), * HIV negative, HBs negative, HCV negative Inclusion criteria for DLBCL patients : * A biopsy proven diagnosis of de novo DLBCL according to the current WHO criteria, * Immunohistochemistry for GCB/nonGC classification according to Hans' algorithm * Patients with advanced-stage disease defined as Ann Arbor stages III or IV, or stages I or II with bulky disease (\>7cm) Inclusion criteria for non-small cell lung cancer patients : * A biopsy proven diagnosis of de novo non-small cell lung cancer (all stages) according to the current WHO criteria Inclusion criteria for Hodgkin's lymphoma patients : * A biopsy proven diagnosis of Hodgkin's lymphoma according to the current WHO criteria Inclusion criteria for metastatic breast cancer or with lymph node involvement : * A biopsy proven diagnosis infiltrating lobular or ductal breast carcinoma * with lymph node involvement or metastasis Inclusion criteria for patients with immune thrombocytopenia (ITP) : * Primary ITP was defined by the IWG as a platelet count less than 100 G/L in the absence of other causes or disorders that may be associated with thrombocytopenia. * Bone marrow examination excluding a central aetiology of thrombocytopenia Inclusion criteria for healthy volunteers : \- Inclusion criteria for blood donation according to the Etablissement Français du Sang (EFS) criteria Exclusion Criteria: General non-inclusion criteria : * Age \< 18 years et \> 75 years, * Pregnant women, * Person legally involved in a case * No social security affiliation * Signed informed consent not obtained, * Preliminary treatment (even corticoid treatment). * HIV positive, HBs positive, HCV positive Non-inclusion criteria for DLBCL patients : * Lymphoma other than DLBCL, * Transformation of a low grade lymphoma to a high grade lymphoma (DLBCL), * Extranodal marginal zone lymphoma of MALT lymphoma, * Post-transplant lymphoproliferative disorders, * Lymphoblastic lymphoma, * Burkitt's lymphoma, * Carcinoma or history of carcinoma except in situ cervical carcinoma. Non-inclusion criteria for non-small cell lung cancer patients : None Non-inclusion criteria for Hodgkin patients : \- Non Hodgkin's lymphoma Non-inclusion criteria for metastatic breast cancer or with lymph node involvement : * Carcinoma other than infiltrating lobular or ductal breast carcinoma * Chemotherapy in 30 days preceding the inclusion * Hormonotherapy in 7 days preceding the inclusion * Carcinoma or history of carcinoma except in situ cervical carcinoma. * Hemoglobin level \< 10g/dl Non-inclusion criteria for patients with immune thrombocytopenia (ITP) : \- Central aetiology of the thrombocytopenia Non-inclusion criteria for healthy volunteers : \- Exclusion criteria for blood donation according to the Etablissement Français du Sang (EFS) criteria
References
Publications (0)
Data not yet available