autologous infusions...autologous infusions alisha mussetter – clinical research coordinator ii...
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Autologous InfusionsAlisha Mussetter – Clinical Research Coordinator IIWednesday February 17th, 2016
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TRAINING & DEVELOPMENT 2
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
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CIBMTR Autologous Reporting• Centers reporting preferences
– Performing, not reporting– Performing and reporting
• CRF and TED• TED only
– Not performing• Reporting all, not just some
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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
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Quiz
• ANSWER: Yes!
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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
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Pre-TED Form 2400
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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
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Consent• Tandem Autologous transplants
– Prior to 1st HCT, use that date on 2nd HCT• Tandem Autologous-Allogeneic transplants
– Same consent form: Prior to 1st HCT, use that date on 2nd HCT
– Separate consent forms: Both consents must be obtained prior to 1st HCT
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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 1st HCT, use that date on
2nd HCT– Separate consent forms: Both consents required,
patient must be re-approached prior to subsequent HCT
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Number of Products• Q51: Specify number of products infused
from this donor– Single product– Multiple products by Multiple mobilizations– Multiple bags of products
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Determining # of products to report• See Appendix P for info on defining products
Definition # of Products
Single Product
All of these are true:•Single Donor/cell source•Single mobilization method•Single collection method
One
Multiple Products
Any of these are true:•Multiple donors/cell sources•Multiple mobilization methods•Multiple collection methods
Multiple – one for each cell source, mobilization method, and/or collection method
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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
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Example: Multiple Mobilizations• Patient undergoes 3 different mobilizations• 8 total collections• How many products get reported?• Bags are infused over 3 separate infusions• ???
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REST
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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
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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
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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
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Infusion Form 2006
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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)
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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)
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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
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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
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Quiz
• ANSWER: False!You should report the start of the first bag and the stop of the last bag
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Product Analysis• Q158: Analysis Time Points
– Product arrival– Pre-cryopreservation– Post-thaw– At infusion
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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
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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 “Pre-
cryopreservation” 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
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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
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Mobilization Filgrastin + G-CSF
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
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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
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Quiz
• ANSWER: Pre-Cryopreservation and At Infusion timepoints should be reported
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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 1012
• 1,000,000,000,000
Billions • 10^9 or 109
• 1,000,000,000
Millions • 10^6 or 106
• 1,000,000
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Scientific Notation• Scientific notation is a way of writing numbers, that are
too big or too small to be conveniently written, in decimal form.
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1.5 x 10^6
1-5-0-0-0-0-0.
1,500,000
Scientific Notation• Scientific notation is a way of writing numbers, that are
too big or too small to be conveniently written, in decimal form.
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63.4 x 10^8
6-3-4-0-0-0-0-0-0-0.
6,340,000,000
6.34 x 10^9
Cell Dose vs. Total Cell Counts• Pay attention to units, especially exponents
– Total or absolute cells – 106, 109
– Cell Dose 105/kg, 107/kg– Cell Concentration 108/mL, 109/mL
• CIBMTR Forms capture TOTAL CELLS– Patient weight used to calculate cell dose– Volume used to calculate cell concentration
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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
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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
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Quiz
• ANSWER: 1.25 x 10^7
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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
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Questions?
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