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This study is a multicenter, retrospective data collection of routine clinical use with the Spectra Optia® apheresis system for white blood cell depletion.
The goal of this study is to gather a broader knowledge and information from routine clinical use on the performance and safety of white blood cell depletion procedures with the Spectra Optia® apheresis system.
In order to do so, retrospective data on white blood cell depletion procedures with the Spectra Optia® apheresis system done in routine use in 3 different centers will be collected and analyzed.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectra Optia® Apheresis System | Device | White Blood Cell Depletion |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure | Percent decrease in WBC count calculation: (WBCpre - WBCpost) / WBCpre x 100% | immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure |
| Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia. | Collection efficiency for WBC achieved by Spectra Optia System calculation: (WBC/µL depletion product x depletion product volume) / (WBCpre + WBCpost) / 2 x total processed blood volume) | immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure |
| Adverse Events | Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medical device, whether or not considered related to the medical device and/or procedure. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the medical device and/or procedure. | Participants were followed for the duration of the procedure and for up to 24 hours after the procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pre-procedure WBC Count | Pre-procedure WBC count | Prior to Each Spectra Optia Apheresis Procedure |
| Post-procedure WBC Count | Post-procedure WBC count |
Inclusion Criteria:
Exclusion Criteria:
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Patients who have undergone white blood cell depletion via the Spectra Optia Apheresis System which is likely to include patients with severe leukocytosis in acute leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, or in chronic myelogenous leukemia) or to prevent tumor lysis syndrome.
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| Name | Affiliation | Role |
|---|---|---|
| Isobelle Galeon, MD, MPH, MSCS | Medical Monitor, Clinical Safety | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Gasthuisberg | Leuven | 3000 | Belgium | |||
| Institute for Transfusion Medicine and Immunohaematology, German Red Cross Blood Donor Service Baden-Württemberg-Hessen gGmbH, Johann-Wolfgang-Goethe-University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Who Received a Minimum of 1 WBCD Procedure | Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0-2 Hour Period |
| |||||||||||||
| 0-24 Hour Period |
|
Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System.
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Who Received At Least 1 WBCD Apheresis Procedure | Eligible subjects who received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure | Percent decrease in WBC count calculation: (WBCpre - WBCpost) / WBCpre x 100% | The Full Analysis Set comprised all 43 patients (58 procedures) for whom WBCD data were collected. One patient terminated the first procedure prematurely and therefore did not have post-procedure data, resulting in a total of 57 units analyzed. | Posted | Mean | Standard Deviation | % change in subject's WBC count | immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure | procedures | procedures |
|
Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 2 hours post-procedure for 43 patients and 58 procedures. Adverse event data (including serious adverse events [SAEs]) were collected from the time of the start of the WBCD procedure through 24 hours post-procedure for 32 patients and 41 procedures.
Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, version 17.0).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0-2 Hour Safety Data Collection | Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; safety data collected for 2 hours post apheresis procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA®, version 17 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA®, version 17 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Isobelle Galeon, MD, MPH, MSCS, Medical Monitor Clinical Safety | Terumo BCT | +1 303 542-5166 | Isobelle.Galeon@Terumobct.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 28, 2017 | Feb 11, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 18, 2014 | Mar 23, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D007964 | Leukocytosis |
| ID | Term |
|---|---|
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
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| Following apheresis procedure |
| Patient's Platelet Count Pre-depletion Procedure | Patient's platelet count pre-depletion procedure | Prior to Each Spectra Optia Apheresis Procedure |
| Patient's Platelet Count Post-depletion Procedure | Patient's platelet count post-depletion procedure | Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours. |
| Whole Blood Processed (mL) | Volume of patient's blood processed in mL during the apheresis procedure | Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours. |
| Whole Blood Flow mL/Min | Whole Blood Flow in mL/min measured during the white blood cell depletion procedure | Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours. |
| Procedure Duration | The duration of the WBCD procedure measured in minutes | Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours. |
| Platelet Change (% Change) | % change in patient's pre and post-depletion procedure platelet counts | Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours. |
| Waste Bag Volume | Volume of the depletion product | Post each Spectra Optia Apheresis Procedure |
| Frankfurt am Main |
| 60528 |
| Germany |
| Szent Istvan and Szent Laszlo Hospital of Budapest | Budapest | 1097 | Hungary |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Total Blood Volume | Mean | Standard Deviation | Liters |
|
| Units | Counts |
|---|---|
| Participants |
|
| procedures |
|
|
| Primary | Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia. | Collection efficiency for WBC achieved by Spectra Optia System calculation: (WBC/µL depletion product x depletion product volume) / (WBCpre + WBCpost) / 2 x total processed blood volume) | The CE of the WBCD procedures was measured from the waste bag (depletion product) contents from Sites 2 and 3. WBC counts were not available from the waste bags for subjects treated at Site 1. | Posted | Mean | Standard Deviation | percent of processed WBCs | immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure | procedures | procedures |
|
|
|
| Primary | Adverse Events | Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medical device, whether or not considered related to the medical device and/or procedure. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the medical device and/or procedure. | Full and Safety Analysis Sets. 53.5% of subjects with acute myeloid leukemia (AML), 18.6% of subjects with chronic lymphocytic leukemia, < 10% of subjects with other diagnoses. The WBCD procedure was performed most frequently to treat leukocytosis (44.2%), to prevent tumor lysis syndrome (34.9%), or to treat increased blood viscosity (20.9%). | Posted | Number | Number of subjects with at least 1 TEAE | Participants were followed for the duration of the procedure and for up to 24 hours after the procedure. |
|
|
|
| Other Pre-specified | Pre-procedure WBC Count | Pre-procedure WBC count | The Full Analysis Set comprised all 43 patients (58 procedures) for whom WBCD data were collected. | Posted | Mean | Standard Deviation | cells x 10^9/L | Prior to Each Spectra Optia Apheresis Procedure | procedures | procedures |
|
|
|
| Other Pre-specified | Post-procedure WBC Count | Post-procedure WBC count | Data were collected on a total of 58 procedures, however one patient terminated the first procedure prematurely and therefore did not have post-procedure data. | Posted | Mean | Standard Deviation | cells x 10^9/L | Following apheresis procedure | procedure | procedure |
|
|
|
| Other Pre-specified | Patient's Platelet Count Pre-depletion Procedure | Patient's platelet count pre-depletion procedure | Full and Safety Analysis Sets. | Posted | Mean | Standard Deviation | cells x 10^3/L | Prior to Each Spectra Optia Apheresis Procedure | procedures | procedures |
|
|
|
| Other Pre-specified | Patient's Platelet Count Post-depletion Procedure | Patient's platelet count post-depletion procedure | Full and Safety Analysis Sets. Data were collected on a total of 58 procedures, however one patient terminated her first procedure prematurely and therefore did not have post-procedure data. | Posted | Mean | Standard Deviation | cells x 10^3/L | Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours. | procedures | procedures |
|
|
|
| Other Pre-specified | Whole Blood Processed (mL) | Volume of patient's blood processed in mL during the apheresis procedure | Full and Safety Analysis Sets | Posted | Mean | Standard Deviation | mL | Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours. | procedures | procedures |
|
|
|
| Post-Hoc | Total Blood Volumes (TBV) Processed | Number of times the patient's TBV was processed during the apheresis procedure based on the patient's estimated TBV (Estimated by Nadler's formula for total blood volume of a human being based on gender, height, and weight). | Full and Safety Analysis Sets | Posted | Mean | Standard Deviation | TBV | Post each Spectra Optia Apheresis Procedure | procedures | procedures |
|
|
|
| Other Pre-specified | Whole Blood Flow mL/Min | Whole Blood Flow in mL/min measured during the white blood cell depletion procedure | Full and Safety Analysis Set | Posted | Mean | Standard Deviation | mL/min | Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours. | procedures | procedures |
|
|
|
| Other Pre-specified | Procedure Duration | The duration of the WBCD procedure measured in minutes | Full and Safety Analysis Sets | Posted | Mean | Standard Deviation | minutes | Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours. | procedures | procedures |
|
|
|
| Other Pre-specified | Platelet Change (% Change) | % change in patient's pre and post-depletion procedure platelet counts | Data were collected on a total of 58 procedures, however one patient terminated her first procedure prematurely and therefore did not have post-procedure data. | Posted | Mean | Standard Deviation | percent change | Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours. | procedures | procedures |
|
|
|
| Other Pre-specified | Waste Bag Volume | Volume of the depletion product | Full and Safety Analysis Sets; One patient terminated the first procedure prematurely, resulting in a total of 57 units analyzed. | Posted | Mean | Standard Deviation | mL | Post each Spectra Optia Apheresis Procedure | procedures | procedures |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 37 |
| 43 |
| EG001 | 0-24 Hour Safety Data Collection | Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System; safety data collected for 24 hours post apheresis procedure | 0 | 32 | 1 | 32 | 30 | 32 |
| Anaemia | Blood and lymphatic system disorders | MedDRA®, version 17 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA®, version 17 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA®, version 17 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA®, version 17 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA®, version 17 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA®, version 17 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA®, version 17 | Systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA®, version 17 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA®, version 17 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA®, version 17 | Systematic Assessment |
|
| Hypogammaglobulinaemia | Immune system disorders | MedDRA®, version 17 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA®, version 17 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA®, version 17 | Systematic Assessment |
|
Study Site reserves the right to publish the results of its work on the Study. The timing of publication however shall not exceed the 6 months after completion of the Study. Study Site and the PI agree to submit copies of any manuscript/abstract proposed for publication to Sponsor at least 30 days in advance of the presentation. Sponsor may require the delay of publication for no longer than 90 days for the purpose of filing patent applications.
| D013568 | Pathological Conditions, Signs and Symptoms |