The History

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The History( future)of TED

• CIBMTR Training Committee
• Note please print a full sized version of
  PrePost-TED for this presentation

TED07_1.ppt
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TED

• Transplant Essential Data
• Created with EBMT October 2000
• TED (Day-100)
• TEDFU (HSCT anniversary)
• EBMT Center data transmitted to CIBMTR in lieu of
  paper Forms

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Introducing Pre-TED Post-TED
TED07_3.ppt
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CIBMTR PrePost-TED Forms

• New for NMDP Centers
• PrePost-TED replaces TED
• (Pre-Reg, MTED, TED TEDFU)
• All transplants, all centers require Pre-TED

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Key Concepts

• Why?
• Whats new?
• Whats changing?
• When to send it?
• Where to find data points?

TED07_2.ppt
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Why change?

• Harmonized Research Forms with NMDP (Research
  Forms)
• Updated TED Forms with EBMT, APBMTG, and other
  groups.
• Stem cell Therapeutics Outcomes Database (SCTOD)
  of the C.W. Bill Young Transplantation Program
• (details www.cibmtr.org)

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Whats new?

• Unique ID Assignment System
• Campus assignments

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Unique ID AssignmentSystem

• New secure, separate database
• Prior to submission of Pre-TED
• New outcomes data ID
• CIBMTR IUBMID is optional
• NMDP RID needed for NMDP search
• Look-up table reference for Team/IUBMID and RID
• EBMT assigned at data loading

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Campus assignments

• Minneapolis or Milwaukee for
• Communication
• Personal contact person
• Paper Form submission
• All recipient Forms
• Not NMDP Search/Donor Forms
• C.P.I.

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Whats changing(for CIBMTR, NMDP or both)?

• Data Transmission Agreements
• Reimbursement
• FormsNet2.0

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Data Transmission Agreements

• Replaces NMDP TCP Agreement
• Replaces CIBMTR DUA
• CIBMTR reimbursement increases to NMDP level

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FormsNet2.0

• New for all Centers
• PrePost-TED/Research Forms
• Free Web-based application
• Includes StemSoft users
• EBMT via ProMISe or FN2.0
• Training provided
• Send data/error corrections
• Monitor Forms Due Report

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When? Single schedulePre-TED up to 14d before
PrepReg

• Registration or No Form Due Post-TED
• Day 100
• 6 mo
• Annually

• Yes Research Form Due
• no Post-TED
• Day 100
• 6 mo
• Annually
• new for CIBMTR

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Subsequent HSCT

• Submit new Pre-TED for subsequent HSCT
• DCIs only reported on Post-TED or Research Forms
  as applicable
• Form start/end dates should fit on a timeline
  with minimal overlap.

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Timeline of HSCT
Acute and/or chronic GvHD
Viral infections CMV, VZV, PCP, IP
Complications
Secondary tumors, cataracts, endocrine changes,
QoL
Bacterial infections
VOD
HSV mucositis
PBSC/BM harvests in ABMT
Marrow function
Blood Marrow Changes
Collect freeze
Immune function
BM/SC re-infusion
gcsf
eg DHAP and GF and PBSC
BMT Process
Red cell transfusions
Donor search or obtain autologous stem cells
Chemo XRT
Platelet transfusions
Growth factors
Supportive Therapy
Antiemetics
Nutrition
Antibiotics
TIME LINE
-12
-4
-2
0
1
2
6
60
months
Marrow failure
Disease remission
Disease recurrence
Continuous complete remission (cure)
High-dose myeloablative therapy
Primary diagnosis and treatment
Relapse and salvage therapy
Disease State
TED07_20.ppt
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optional for non-U.S. centers

• Not part of the international essential dataset
• Needed for
• SCTOD
• Selection algorithm for all Research Centers
  (U.S. and non-U.S.)
• NMDP Centers Research Center
• Greatly appreciated from non-U.S. Registering
  only centers.

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Where to find data points?

• New
• Study ID, consent, ethnicity, CMV, co-morbid,
  platelets.
• Changed
• IDs, HSCT, donor type, prep. regimen/intent,
  DX, Pre-status, 100d report, Post-response, DCI.

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Center Identification
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Recipient Identification
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Study ID

• On BMT-CTN, NMDP, RIC-BMT or SCTOD study?
• Indicate study ID
• Related repository
• Recipient Donor submit sample

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Consented for Research?

• Ask the recipient to consent for data to be used
  for research
• Yes )
• No (
• PrePost-TED still mandatory for U.S. citizens,
  allo HSCT

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Ethnicity vs Race?

• Difference between where you/ancestors lived and
  your genetic inheritance
• Important for studies related to access to HSCT

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Disease changes

• W.H.O. classification
• AML/ALL/MDS
• CML t(922) or bcr/abl
• LYM
• Incl Waldenstrom Mac.
• PR w/out prior CR
• MYE new stage/status
• Other uses HCT

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Pre-TED AML
TED07_9.ppt
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Disease classification

• Paper attach relevant sheet only
• Status pre-HSCT matches Research Form Disease
  Inserts
• Resource HSCT physician
• Still Qs? contact us.

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HSCT Chronological number
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Cell Source section
TED07_23.ppt
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Donor type multiples

• Multiple donors answer all Qs
• Donor type
• Which registry
• Skip HLA match section only

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Donor type related

• Syngeneic
• 1 egg, paternal, identical twin
• HLA identical sibling
• garden variety sib
• Dizygotic, fraternal twin
• Matched relatives
• Parent, child, aunt, cousin
• Mismatched relatives 1 vs gt1 antigens

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Donor type unrelated
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Graft Insert changes

• Now HLA, IDM INF Forms
• NMDP facilitated
• HLA IDM NMDP 22/177 50.
• Send only INF
• Related donor in US with repository consent or
  UCB
• HLA IDM with pre-TED
• INF by day 14.

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Performance score/ CMV antibodies
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Prep. Regimen
TED07_28.ppt
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Intent of prep myeloablative?

• Old TED Q was opposite
• If no, list reason for RIC/NST

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Co-morbid Conditions
TED07_31.ppt
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Disease Therapy Planned as of Day 0
TED07_32.ppt
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Abbreviations
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Post-TED
TED07_33.ppt
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ANC recovery

• Report first of three consecutive days of ANC
  greater than 500
• Usually not before 8-10 days for myeloablative
  HSCT
• May never become neutropenic for
  reduced-intensity
• Donor engraftment is demonstrated by chimerism

TED07_35.ppt
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Post-TED ANC Recovery
TED07_36.ppt
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Initial platelet recovery
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Second Cancer
TED07_56.ppt
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Survival
TED07_54.ppt
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Post-HSCT Therapy
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Non-malignant disease
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Best response
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First relapse/progression
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Method of Detection of Disease

• Molecular (most sensitive)
• Blood or marrow
• Bcr/abl, bcl-2
• Cytogenetic (mod. sensitive)
• Blood or marrow
• t(922), t(1418)
• Hematologic (least sensitive)
• Blood or marrow appearance

TED07_49.ppt
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Additional treatments?
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Latest assessment
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Different disease
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PrePost TED Manual

• Welcome to CIBMTR Registration
• dknutson_at_mcw.edu

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Unique ID AssignmentWhy? To prevent duplicates

• DOB
• Gender
• Recipient name
• Mothers maiden name
• City-state-country of birth
• U.S. Social Security , IUBMID, RID
• Primary disease group
• Tentative HSCT date
• Prior HSCT date, cell source product.

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Graft Manipulation
TED07_25.ppt
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GVHD prophylaxis
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Other toxicity modifying regimen
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GVHD
TED07_47.ppt
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DCI
TED07_52.ppt