autologous infusions...autologous infusions alisha mussetter – clinical research coordinator ii...

Autologous InfusionsAlisha Mussetter – Clinical Research Coordinator IIWednesday February 17th, 2016

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

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


CIBMTR Autologous Reporting• Centers reporting preferences

– Performing, not reporting– Performing and reporting

• CRF and TED• TED only

– Not performing• Reporting all, not just some


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


Quiz

• ANSWER: Yes!


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


Pre-TED Form 2400


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


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


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


Number of Products• Q51: Specify number of products infused

from this donor– Single product– Multiple products by Multiple mobilizations– Multiple bags of products


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


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


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


REST


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


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


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

19TRAINING & DEVELOPMENT

Infusion Form 2006


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)


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)


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


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

Quiz

• ANSWER: False!You should report the start of the first bag and the stop of the last bag


Product Analysis• Q158: Analysis Time Points

– Product arrival– Pre-cryopreservation– Post-thaw– At infusion


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


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


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

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


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


Quiz

• ANSWER: Pre-Cryopreservation and At Infusion timepoints should be reported


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





1.5 x 10^6

1-5-0-0-0-0-0.

1,500,000




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


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


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


Quiz

• ANSWER: 1.25 x 10^7


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


Questions?

41

autologous infusions...autologous infusions alisha mussetter – clinical research coordinator ii...

Documents