Autologous Infusions Alisha Mussetter Clinical Research Coordinator II Wednesday February 17 th, 2016

Transcription

1 Autologous Infusions Alisha Mussetter Clinical Research Coordinator II Wednesday February 17 th, 2016

2 How to participate in a live poll via the mobile app Ensure your phone is connected to WiFi or cellular network. Download the BMTTANDEM mobile app, if you have not done so already. When you launch the app for the first time, make sure you select OK when prompted to Sync. TAP on the LIVE Poll icon in the dashboard Select the session or presentation you are viewing and the questions will be displayed either as a question number or the actual question itself. Note: This will not appear until the session begins. Select the question based on instruction from the speaker Enter your response, based on options presented by the speaker and TAP Submit. (Wait for speaker s instructions before you respond to questions) TRAINING & DEVELOPMENT 2

3 Objectives Reporting levels and requirements Pre-TED Form 2400 Autologous reporting areas Consent Determining number of products Infusion Form 2006 Autologous reporting areas Product processing Tumor cell detection Product collection and infusion analysis TRAINING & DEVELOPMENT 3

4 CIBMTR Autologous Reporting Centers reporting preferences Performing, not reporting Performing and reporting CRF and TED TED only Not performing Reporting all, not just some TRAINING & DEVELOPMENT 4

5 CIBMTR Autologous Reporting As of May 2015, all autologous transplants reported will at minimum require a Pre-Ted Form 2400 Increases database integrity and completeness This includes patients that decline research consent Reported transplants subject to CPI and Audit TRAINING & DEVELOPMENT 5

6 Quiz ANSWER: Yes! TRAINING & DEVELOPMENT 6

7 Quiz ANSWER: Yes! Even though the transplant was before the autologous reporting requirement, since it was reported after May 2015, a Pre-TED is required TRAINING & DEVELOPMENT 7

8 Pre-TED Form 2400 TRAINING & DEVELOPMENT 8

9 Consent If your center is performing and reporting, you should be approaching all patients for research consent. Not approached rarely used TED only centers follow the same rule TRAINING & DEVELOPMENT 9

10 Consent Tandem Autologous transplants Prior to 1 st HCT, use that date on 2 nd HCT Tandem Autologous-Allogeneic transplants Same consent form: Prior to 1 st HCT, use that date on 2 nd HCT Separate consent forms: Both consents must be obtained prior to 1 st HCT TRAINING & DEVELOPMENT 10

11 Consent Autologous HCT followed by subsequent Autologous HCT (not tandem) CIBMTR does not require additional consent form be signed However, center s IRB may require a second consent and should be followed Autologous HCT followed by subsequent Allogeneic HCT (not tandem) Same consent form: Prior to 1 st HCT, use that date on 2 nd HCT Separate consent forms: Both consents required, patient must be re-approached prior to subsequent HCT TRAINING & DEVELOPMENT 11

12 Number of Products Q51: Specify number of products infused from this donor Single product Multiple products by Multiple mobilizations Multiple bags of products TRAINING & DEVELOPMENT 12

13 Determining # of products to report See Appendix P for info on defining products Definition # of Products Single Product Multiple Products All of these are true: Single Donor/cell source Single mobilization method Single collection method Any of these are true: Multiple donors/cell sources Multiple mobilization methods Multiple collection methods One Multiple one for each cell source, mobilization method, and/or collection method TRAINING & DEVELOPMENT 13

14 Example: Multiple Mobilizations PBSC collected using G-CSF 2 days of collection, not enough cells Plerixafor and G-CSF given, cells collected How many products get reported? This would be reported as 2 products, as we would not be able to capture that information accurately unless the PBSC collections were not considered 2 different products TRAINING & DEVELOPMENT 14

15 Example: Multiple Mobilizations Patient undergoes 3 different mobilizations 8 total collections How many products get reported? Bags are infused over 3 separate infusions??? TRAINING & DEVELOPMENT 15

16 Mobilization #1 Filgrastim Mobilization #2 + Plerixifor Mobilization #3 Filgrastim + Plerixifor Collection #1 Collection #2 Collection #1 Collection #2 Collection #1 Collection #2 Collection #3 Collection #4 Infusion #1: 3 bags 2 Products REST Infusion #2: 2 bags 2 Products Infusion #3: 3 bags 3 Products TRAINING & DEVELOPMENT 16

17 Example: Change in mobilization Patient receives G-CSF, PBSC collected Cell count poor Additional G-CSF given and additional PBSC collected How many products get reported? This is not considered a new mobilization and would be counted as 1 product TRAINING & DEVELOPMENT 17

18 Reporting multiple collections All cells collected for a single mobilization event should be combined into a single product analysis Increasing the dose of a drug does not count as a new mobilization Adding a new drug that wasn t planned would count as a new mobilization TRAINING & DEVELOPMENT 18

19 Subsequent Allogeneic Donor Q60: For subsequent allo transplant following an auto, this question should be answered no rather than an override of unknown This field is used to determine if a Form 2005 is required for the donor TRAINING & DEVELOPMENT 19

20 Infusion Form 2006 TRAINING & DEVELOPMENT 20

21 Product Processing Q60: Was the entire product thawed Entire product is all bags collected from a mobilization event (remember, definition!) This could be from several individual collections From this point forward, the cells that were thawed with the intent of infusion, this becomes the entire product What portion of product was manipulated prior to infusion (Q71 and 72) Was entire product infused (Q204) TRAINING & DEVELOPMENT 21

22 Product Processing Report start of the first cells and the end of the last cells Q65 and Q66: Thaw start and stop time Q199/200 and Q201/202: Infusion start and stop time (and date) TRAINING & DEVELOPMENT 22

23 Tumor cell detection Presence of disease in autologous products or in the patient at the time of product collection Information about testing done on the product and/or on the autologous donor s peripheral blood or bone marrow just prior to collection TRAINING & DEVELOPMENT 23

24 Tumor cell detection Patient with CML is undergoing autologous collection and has the following studies performed: Peripheral blood PCR positive for Philadelphia chromosome Collected product PCR negative for Philadelphia chromosome Bone marrow pathology; no PCR studies performed 24

25 Quiz ANSWER: False! You should report the start of the first bag and the stop of the last bag TRAINING & DEVELOPMENT 25

26 Product Analysis Q158: Analysis Time Points Product arrival Pre-cryopreservation Post-thaw At infusion TRAINING & DEVELOPMENT 26

27 Scenario Cryopreserved Marrow or PBSC or Cord Blood Units, collected at an outside facility Only report analysis completed at your center Report Post thaw timepoint Testing prior to washing Report At Infusion timepoint Thawed, tested and infused without manipulation Testing after washing Center tests only viability Product Volume and Viability Date of analysis = Date of viability TRAINING & DEVELOPMENT 27

28 Scenario Cryopreserved Marrow or PBSC, collected at the transplant center Report At Infusion timepoint Complete testing post-thaw, no other testing done Report Product Arrival or Precryopreservation timepoint and At Infusion timepoint Complete testing prior to cryopreservation, only viability tested post-thaw No testing post thaw Cell counts must be adjusted for the volume of product infused TRAINING & DEVELOPMENT 28

29 Scenario Portion of product infused Product Arrival or Pre-cryopreservation analysis of entire product At Infusion of just the product infused Adjusted cell counts (CD34+ and TNC, etc.) for the volume infused Post Thaw viability and culture testing Mobilization Filgrastin + G-CSF Collection #1 Collection #2 Collection #3 Collection #4 TRAINING & DEVELOPMENT 29

30 Product Manipulation Form 2400 and Form 2006 Cryopreservation is not considered a method of manipulation Should not be reported in the manipulation section This includes plasma removal as part of the cryopreservation process Cryopreservation is reported elsewhere on the form TRAINING & DEVELOPMENT 30

31 Quiz A patient has a 2 day PBSC collection at HopScotch Blood Center (a collection facility for CandyLand Hospital). A single product is collected; all cell counts are immediately completed, culture and viability testing done and the product cryopreserved. Months later, 2 of the 6 bags of product are infused in the patient and only culture testing is done at the time of infusion TRAINING & DEVELOPMENT 31

32 Quiz ANSWER: Pre-Cryopreservation and At Infusion timepoints should be reported TRAINING & DEVELOPMENT 32

33 Scientific Notation Scientific notation is a way of writing numbers, that are too big or too small to be conveniently written, in decimal form. Trillions 10^12 or ,000,000,000,000 Billions Millions 10^9 or 109 1,000,000,000 10^6 or 106 1,000,000 TRAINING & DEVELOPMENT 33

34 Scientific Notation Scientific notation is a way of writing numbers, that are too big or too small to be conveniently written, in decimal form. 1.5 x 10^ ,500,000 TRAINING & DEVELOPMENT 34

35 Scientific Notation Scientific notation is a way of writing numbers, that are too big or too small to be conveniently written, in decimal form x 10^ ,340,000, x 10^9 TRAINING & DEVELOPMENT 35

36 Cell Dose vs. Total Cell Counts Pay attention to units, especially exponents Total or absolute cells 10 6, 10 9 Cell Dose 10 5 /kg, 10 7 /kg Cell Concentration 10 8 /ml, 10 9 /ml CIBMTR Forms capture TOTALCELLS Patient weight used to calculate cell dose Volume used to calculate cell concentration TRAINING & DEVELOPMENT 36

37 TNC vs. Nucleated White Blood Cells Captures the counts that your lab provides more accurately Total nucleated cells (TNC): the total nucleated cell count includes nucleated red and nucleated white blood cells. Nucleated white blood cells: (also known as leukocytes) the nucleated cell count includes the neutrophils, eosinophils, basophils, lymphocytes, and monocytes. Nucleated red blood cells (nrbc): (also known as normoblasts) the total count of red blood cells containing a nucleus Uncorrected or Corrected: Talk to your lab to find out which one is provided to you TRAINING & DEVELOPMENT 37

38 Cell Viability Cytolysis or membrane leakage assays bind to the DNA of cells Live cells have intact membrane, DNA can t be stained Dead cells, membrane is breaking down and DNA becomes stained 7-AAD and Propidium Iodide Fluorescent marker; detected by fluorescence microscopy and flow cytometry More than one technique performed, report 7-AAD results Trypan Blue Stains dead cells blue Uses microscopy to count dead cells Multiple Bags Provide an average of viabilities tested TRAINING & DEVELOPMENT 38

39 Quiz ANSWER: 1.25 x 10^7 TRAINING & DEVELOPMENT 39

40 Summary Understand what your center s reporting requirements are and what your center s IRB requires for consent Define a single product and how to report multiple bags of product and multiple mobilizations Better understanding of product analysis section and what reporting is necessary Including cell counts, viability, and product manipulation TRAINING & DEVELOPMENT 40

41 Questions? 41