Cell Therapy Reporting Tracks and Follow-Up Schedules

Beginning in July of 2023, a reporting track will now be set for all cell therapy CRIDs reported to CIBMTR. The track will be set by the center reporting preference and infusion type.

*TED vs CRF reporting for cell therapy was launched in the Summer 2023 release. It is determined by the center reporting preference and infusion details; it is not a center level attribute like HCT reporting.

There are five cell therapy reporting follow-up schedules. The follow-up schedule can be determined by either Pre-CTED (4000) Form or Cellular Therapy Product (4003) Form.

Missing Follow-Up Forms
If the Pre-CTED (4000) Form is completed and only the Cellular Therapy Product (4003) Form has come due, the Form 4003 is required to determine the follow-up schedule.

15 Year Follow-Up (CRF)

• Applies to:
  • commercially available PASS studies currently accruing
  • BMT CTN studies
  • genetically modified products (other than CAR-T) either stand alone or post-HCT
  • registry partners
• Follow-up schedule: 100 day – 15 years
• Follow-up schedule set by F4000 OR F4003
• Forms: F4000, F4001, F4003, F4006, F4100, F4101, F2402 + disease forms (when applicable), 3500 + 3501 (when applicable)
  

Standard Follow-Up (CRF)

• Applies to a portion of commercially available products after PASS study accrual has been met and consent is yes
• Follow-up schedule: 100d – 6yr, 8yr, 10yr, 12yr, 14yr
• Follow-up schedule set by F4000 OR F2402
• Forms: F4000, F4001, F4003, F4006, F4100, F4101, F2402 + disease forms (when applicable), 3500 + 3501 (when applicable)
  

Standard Follow-Up (TED)

• Applies to:
  • commercially available PASS studies that are currently accruing but CIBMTR research database consent is not obtained (REMS center reporting preference)
  • commercially available products no longer part of a PASS study and consent is yes
  • non-commercial CAR-T products
  • stand-alone non-genetically modified cell therapy infusions without a history of HCT
• Follow-up schedule: 100d – 6yr, 8yr, 10yr, 12yr, 14yr
• Follow-up schedule set by F4000 OR F4003
• Forms: F4000, F4003, F4006, F4100, F2402, 3500 (when applicable)
  

100-Day Only Follow-Up

• Applies to post-HCT non-genetically modified cell therapy infusions (excludes Donor Lymphocyte Infusions (DLIs))
• Follow-up schedule: 100-day only
• Follow-up schedule set by F4000
• Forms: F4000, F4003, F4006, single F4100 at 100d, F2402, 3500 (when applicable)
  

CTRM

• Applies to:
  • cell therapy infusions for regenerative medicine indications (cardiovascular disease, musculoskeletal disorder, neurologic disease, ocular disease, pulmonary disease)
  • genetically modified cellular therapy products (not CAR-T) when the center reporting preference is Do not perform/Perform do not report/Research
• Follow-up schedule: None
• Follow-up schedule set by F4000 OR F4003
• Forms: F4000, F4003, F4006
  

No Follow-Up

• Applies to:
  • consent to CIBMTR Research Database has not been obtained for commercially available CAR-T products no longer part of a PASS study
  • other genetically modified cell therapy products
  • non-genetically modified cell therapy products
• Follow-up schedule: None
• Follow-up schedule set by F4000 OR F4003
• Forms: F4000 + F2402
  

TED (Standard & 100-Day Only)	CRF (Standard Follow-Up CRF &15 years)	CTRM	No Follow-Up
Commercial product, no consent, REMS center (Standard Follow-Up TED)	Commercial CAR-T on study (15 years)	Indication = Cardiovascular disease, Musculoskeletal disorder, Neurologic disease, Ocular disease, Pulmonary disease	Commercial CAR-T, no consent (cannot be on study), Research center
Commercial product not on study (Standard Follow-Up TED)	BMT CTN	Non-commercial genetically modified non-CAR-T products	Genetically modified cell therapy products other than CAR-T, no consent
Non-commercial products (Standard Follow-Up TED)	Genetically modified products (other than CAR-T) either stand alone or post-HCT		Non-genetically modified cell therapy products, no consent
Stand-alone non-genetically modified cell therapy infusions without a history of HCT (Standard Follow-Up TED)	Commercial CAR-T not on study (Standard Follow-Up CRF)
Post-HCT non-genetically modified cell therapy infusions (100 day only)

Commercial products = Kymriah®, Yescarta®, Tecartus®, Abecma®, Breyanzi®, Carvykti®, Tecelra®, Amtagvi®

If forms did not come due as expected, or you have questions on the forms that did come due, please submit a ticket via CIBMTR Center Support.

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