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PCI-32765DBL3001: Sample Management (All countries except CN, JP) INVESTIGATIONAL SITE SALAMANCA (SPAIN) Sorting of Malignant Cells QUINTILES (REGION)

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Presentation on theme: "PCI-32765DBL3001: Sample Management (All countries except CN, JP) INVESTIGATIONAL SITE SALAMANCA (SPAIN) Sorting of Malignant Cells QUINTILES (REGION)"— Presentation transcript:

1 PCI-32765DBL3001: Sample Management (All countries except CN, JP) INVESTIGATIONAL SITE SALAMANCA (SPAIN) Sorting of Malignant Cells QUINTILES (REGION) Confirmation of DLBCL and non- GCB subtype, bridging study COVANCE (REGION) Shipment and storage of samples Blood samples for Biomarker Evaluation (C1D1 and at EOT/PD) FFPE Tumor block or 23 unstained positively charged 4-micron slides for non-GCB subtype determination + Local Pathology report for DLBCL confirmation (Screening) FRONTAGE (USA) Analysis of PK Samples (SM01-04) COVANCE (Geneva) Storage of Samples PK samples (subset of patients, at C1-2-3) Not for AR, AU, BR, MX Serum MRD samples (EOT&Posttreatment phase) fresh lymph node biopsy (at PD if feasible-) Please note that 13 unstained slides are required for non-GCB determination/bridging study; 10 additional slides required for biomarker analysis but ONLY for patients with non-GCB subtype confirmed (if sites prefer these 10 slides can be sent after randomization) 5 slides (Mutations) - CGL 3 slides (GEP) – CGL 2 slides (BCL2 & MYC) - PhenoPath 10 unstained slides for biomarker studies TBD Fresh Lymph Node Biopsy (SM06)/MRD V4.0 15JUL2013

2 PCI-32765DBL3001: Sample Management (China) INVESTIGATIONAL SITE QUINTILES (REGION) Confirmation of DLBCL and non- GCB subtype, bridging study COVANCE (REGION) Shipment and storage of samples Blood samples for Biomarker Evaluation (C1D1 and at EOT/PD) Will not be collected in China FFPE Tumor block or 15 unstained positively charged 4-micron slides for non-GCB subtype determination + Local Pathology report for DLBCL confirmation (Screening) FRONTAGE (USA) Analysis of PK Samples (SM01-04) PK samples (subset of patients, at C1-2-3) 2 slides (BCL2 & MYC) - ??? 2 unstained slides for biomarker studies V4.0 15JUL2013 2 unstained slides for biomarker studies only as it will not be possible to export the slides for GEP and somatic mutational analysis outside China Serum MRD samples (EOT&Posttreatment phase) Will not be collected in China fresh lymph node biopsy (at PD if feasible-) Will not be collected in China

3 PCI-32765DBL3001: Sample Management (Japan) INVESTIGATIONAL SITE SALAMANCA (SPAIN) Sorting of Malignant Cells QUINTILES (REGION) Confirmation of DLBCL and non- GCB subtype, bridging study COVANCE (REGION) Shipment and storage of samples Blood samples for Biomarker Evaluation (C1D1 and at EOT/PD) FFPE Tumor block or 23 unstained positively charged 4-micron slides for non-GCB subtype determination + Local Pathology report for DLBCL confirmation (Screening) FRONTAGE (USA) Analysis of PK Samples (SM01-04) COVANCE (Geneva) Storage of Samples Please note that 13 unstained slides are required for non-GCB determination/bridging study; 10 additional slides required for biomarker analysis but ONLY for patients with non-GCB subtype confirmed (if sites prefer these 10 slides can be sent after randomization) 5 slides (Mutations) - CGL 3 slides (GEP) – CGL 2 slides (BCL2 & MYC) - PhenoPath 10 unstained slides for biomarker studies TBD MRD V4.0 15JUL2013 PK samples (subset of patients, at C1-2-3) Serum MRD samples (EOT&Posttreatment phase) fresh lymph node biopsy (at PD if feasible) (Will not be collected in Japan)

4 QUINTILES REGIONAL LAB CLINICAL SITE COVANCE PHENOPATH PATHOLOGY ARCHIVAL SITE PCI- 32765DBL3001: Tumor Sample Flow When not already present at clinical site, pathology site will send tumor block or 23 unstained 4-micron slides upon request to clinical site Clinical site will forward tumor block or 23 unstained 4-micron slides to Quintiles for non-GCB determination Used for eligibility (subtyping and required bridging studies for CoDx) 3 unstained slides for bcl2 IHC and MYC FISH 7 unstained slides for GEP & Exome Sequencing DLBCL Confirmation and non-GCB results will be sent via mBox to the site within 4-5 business days upon receipt at Quintiles Tumor block will be returned to clinical site within 2-3 weeks Used for retrospective analysis following completion of trial V4.0 15JUL2013 COVANCE REGIONAL LAB

5 Region/CountryCovanceQuintiles NA and LACovance CLS IndianapolisQuintiles Westmont EUROPECovance CLS GenevaQuintiles Edinborough AU,Covance CLS SingaporeQuintiles Singapore CNCovance CLS ShangaiQuintiles Beijing JPCovance CLS CB Trial Laboratory BML General Laboratory Kawagoe City(Tokyo Area) Quintiles Singapore PCI-32765DBL3001 Overview Regional Labs


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