Pre-TED 2400 Form Revision Module 1 An educational module with audio Length: approx. 20 minutes
Objectives • Describe Form Revisions • Review changes in Pre-TED submission • Review Donor reporting • Practice calculation to report preparative regimen drugs
Pre-TED Essentials NEW : The Pre-TED is now required for ALL HCTs.
Auto-population CRID Assignment Pre-TED Baseline
New Section Order on Pre-TED • Key fields • Recipient Data • Hematopoietic Cellular Transplant (HCT) • Donor Information • Consent • Product Processing / Manipulation • Clinical Status of Recipient Prior to the Preparative Regimen • Co-morbid Conditions • Pre-HCT Preparative Regimen (Conditioning) • GVHD Prophylaxis • Other Toxicity Modifying Regimen • Post-HCT Disease Therapy Planned as of Day 0 • 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 Question 6: Is the recipient participating in a clinical trial? • 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 Human stem cells
ISBT DIN Number • Example of an ISBT DIN Number: • G1517 09 123456 • Facility ID number – 5 characters • Collection Year – 2 digits • Serial Number – 6 digits http://www.iccbba.org/
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)
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
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
CoMorbid Conditions • “Were there clinically significant co-existing diseases or organ impairment at time of patient assessment prior to preparative regimen?” Resource: Data Management Manual Appendix U
Preparative Regimen Intensity (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.
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
Total Prescribed Cumulative Dose Questions 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/kg 12.8 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 doses 60 X 2 = 120 mg/kg dose x # of doses Cy dose to report: 120 mg/kg
End of Module 1 CIBMTRTraining@nmdp.org