Pre-TED 2400 Form Revision

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT

Sharing knowledge. Sharing hope.

Pre-TED 2400 Form Revision

Module 1An educational module with audio

Length: approx. 20 minutes


• Describe Form Revisions

• Review changes in Pre-TED submission

• Review Donor reporting

• Practice calculation to report preparative regimen drugs

Objectives


Pre-TED Essentials

NEW : The Pre-TED is now required for ALL HCTs.


Submission Requirements

• Pre-TED and Baseline for each HCT (Initial or Subsequent)

CRF Track

• Form additions to provide more detailed data for all HCTs

TED Track


Auto-population

2804

20002400Pre-TED Baseline

CRID Assignment


New Section Order on Pre-TED1. Key fields2. Recipient Data3. Hematopoietic Cellular Transplant (HCT)4. Donor Information5. Consent6. Product Processing / Manipulation7. Clinical Status of Recipient Prior to the Preparative Regimen8. Co-morbid Conditions9. Pre-HCT Preparative Regimen (Conditioning)10.GVHD Prophylaxis11. Other Toxicity Modifying Regimen12.Post-HCT Disease Therapy Planned as of Day 013.Primary Disease for HCT


We removed HLA questions from the Pre-TED

“HLA Reporting”(F2005)eLearning


Recipient Data

Ethnicity • Hispanic or Latino• Not Hispanic or Latino• Not applicable (select - if not

a resident of the USA)• Unknown

Race • Not reported (if patient

declined to provide)• Unknown


Zip or Postal code

5 Digits – The Recipient’s Home Address.


Clinical Trials

• RCI-BMT (Resource for Clinical Investigation in Blood and Marrow Transplantation)

• BMT-CTN (Blood and Marrow Transplant Clinical Trials Network)

• USIDNET (United States Immunodeficiency Network)

• COG (Children’s Oncology Group)

• Other sponsor

Question 6: Is the recipient participating in a clinical trial?

Human stem cells


Hematopoietic Cellular Transplant (HCT) Form Section


Donor Information Expanded


ISBT DIN Number

Example of an ISBT DIN Number:

G1517 09 1234561. Facility ID number – 5 characters2. Collection Year – 2 digits3. Serial Number – 6 digits

http://www.iccbba.org/


Donor Types Required IDsAutologous No ID needed

Autologous cord blood unitProvide the Non-NMDP cord blood unit ID that was used by the bank that stored the unit.

NMDP unrelated CBU Provide NMDP Cord Blood Unit ID (the Format is 9xxx-xxxx-x)

NMDP unrelated Donor Provide NMDP Donor ID (the format is xxxx-xxxx-x)

Related Donor No ID needed

Related Cord Blood Unit Provide the Non-NMDP cord blood unit ID used by the bank that stored the unit.

Non-NMDP unrelated donor Provide Non-NMDP Donor ID

Non-NMDP cord blood unit Provide Non-NMDP cord blood unit ID


CIBMTR Registry Codes

Added New Options: St Louis Cord Blood Bank – SLCBB Viacord /Sibling Connection – VIAC Other

Revised: Caitlyn Raymond (CRIR) (previously USA3 and

U3CB) . . .should now be reported under NMDP Codes (USA1 and U1CB)




Choosing the right Registry Code

CBU shipment

PROPERTIES

Show interaction in menu as: Multiple items

Allow user to leave interaction: At any time


Additional Donor Questions Added

•Did the recipient have more than one mobilization event to acquire cells for HCT?

•Specify total number of mobilization events performed

•Specify the agents used in any of the mobilization events reported above.

Autologous HCTs

•Was plerixafor (Mozobil) given at any time prior to the preparative regimen?Related HCTs

only


IRB-approved Consent

New option – Not applicable, means ‘patient not approached’


New Consent Questions

Question 69: Has the donor signed an IRB-approved consent form for submitting research blood samples to the NMDP/CIBMTR? (Related donors only)

Question 65: Did the recipient give permission to be directly contacted for future research?


Research Sample Repository

Center Participation


Product Manipulation

• Diluted• Buffy coat enriched• B-cell reduced• CD8 reduced• Plasma reduced• RBC reduced• Cultured• Genetic Manipulation• PUVA treated• CD34 enriched

(CD34+selection)• CD133 enriched• Monocyte enriched• Mononuclear cells enriched


“Were there clinically significant co-existing diseases or organ impairment at time of patient assessment prior to preparative regimen?”

CoMorbid Conditions

Resource:Data Management Manual

Appendix U


Pre-HCT Preparative Regimen (Conditioning)

The patient’s height and weight at initiation of pre-HCT preparative regimen

Was the radiation fractionated? Was additional radiation given to other sites within 14 days of the pre-HCT preparative regimen?

List of chemotherapy drugs are updated to be the same as on the Baseline (F2000)


Preparative Regimen Intensity

Myeloablative

Non-myeloablative (NST)

Reduced Intensity (RIC)

(Question158)


Radiation Therapy

Enter prescribed dose per fraction in either gray (Gy) or centigray (cGy).

Dose per fraction x total number of fractions from Question: 167, must be equal to the total dose reported in Question: 162


Radiation Reporting – Question 166

Number of days prescribed includes days of REST between days of therapy.

Fraction

REST

Fraction

REST

Fraction


Do Not Include These Drugs

• Corticosteroids for nausea• MESNA for hemorrhagic cystitis• Therapy drugs given between 1st and subsequent HCTs• After Day 0 - ATG and Campath

(report in GVHD section - questions 316-341)

They are NOT preparative

regimen


• Report the total prescribed cumulative dose per transplant protocol.

DO

• Do not report the frequency – daily dose, or q6h, etc.

• Do not report what was actually infused.

Don’t

Total Prescribed Cumulative DoseQuestions 168 - 315


Patient Scenario

A 10 year old child with AML is admitted for BuCy conditioning. The patient weighs 35 kg. The preparative regimen per transplant protocol includes:• Bu 0.8 mg/kg/dose IV every

6 hours x 16 doses(q6h x 4 a day x 4 days = 16 doses)

0.8 mg/kg x16 = 12.8 mg/kg12.8 rounded to 13

Bu dose to report: 13 mg/kg


Patient Scenario (continued)

A 10 year old child with AML is admitted for BuCy conditioning. The patient weighs 35 kg. The preparative regimen per transplant protocol includes:• Cy 60 mg/kg/day IV daily x

2 doses60 X 2 = 120mg/kg dose x # of dosesCy dose to report:120 mg/kg

2400 Knowledge Check

PROPERTIES

On passing, 'Finish' button: Goes to Next Slide

On failing, 'Finish' button: Goes to Next Slide

Allow user to leave quiz: At any time

User may view slides after quiz: At any time

Show in menu as: Multiple items


End of Module 1

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Pre-TED 2400 Form Revision

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