CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT Sharing knowledge. Sharing hope. Pre-TED 2400 Form Revision Module 1 An educational module with audio Length: approx. 20 minutes

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT Describe Form Revisions Review changes in Pre-TED submission Review Donor reporting Practice calculation to report preparative regimen drugs Objectives

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT Pre-TED Essentials NEW : The Pre-TED is now required for ALL HCTs.

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT 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

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT Auto-population Pre-TEDBaseline CRID Assignment

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT New Section Order on Pre-TED 1.Key fields 2.Recipient Data 3.Hematopoietic Cellular Transplant (HCT) 4.Donor Information 5.Consent 6.Product Processing / Manipulation 7.Clinical Status of Recipient Prior to the Preparative Regimen 8.Co-morbid Conditions 9.Pre-HCT Preparative Regimen (Conditioning) 10.GVHD Prophylaxis 11.Other Toxicity Modifying Regimen 12.Post-HCT Disease Therapy Planned as of Day 0 13.Primary Disease for HCT

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT We removed HLA questions from the Pre-TED “HLA Reporting” (F2005)eLearning

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT 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

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT Zip or Postal code 5 Digits – The Recipient’s Home Address. 5 Digits – The Recipient’s Home Address.

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT 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

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT Hematopoietic Cellular Transplant (HCT) Form Section

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT Donor Information Expanded

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT ISBT DIN Number Example of an ISBT DIN Number: G Facility ID number – 5 characters 2.Collection Year – 2 digits 3.Serial Number – 6 digits

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT Donor TypesRequired IDs AutologousNo ID needed Autologous cord blood unit Provide 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 DonorNo 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 donorProvide Non-NMDP Donor ID Non-NMDP cord blood unitProvide Non-NMDP cord blood unit ID

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT 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)

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT

Choosing the right Registry Code

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT 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

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT IRB-approved Consent New option – Not applicable, means ‘patient not approached’

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT 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?

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT Research Sample Repository Center Participation

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT 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

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT “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

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT 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)

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT Preparative Regimen Intensity MyeloablativeNon-myeloablative (NST)Reduced Intensity (RIC) (Question158)

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT 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

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT Radiation Reporting – Question 166 Number of days prescribed includes days of REST between days of therapy. Fraction REST Fraction REST Fraction

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT Do Not Include These Drugs Corticosteroids for nausea MESNA for hemorrhagic cystitis Therapy drugs given between 1 st and subsequent HCTs After Day 0 - ATG and Campath (report in GVHD section - questions )

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT 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 Dose Questions

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT 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

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT 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

CENTER FOR INTERNATIONAL BLOOD & MARROW RESEARCH TRAINING & DEVELOPMENT End of Module 1