This form must be completed for all recipients of cellular therapy (non-HCT), including post-HCT “DCI/DLI” infusions. For recipients of hematopoietic cellular transplants, complete the appropriate HCT follow-up form.

The Post-Cellular Therapy Essential Data (Post-CTED) follow-up form focuses on key follow-up information, including the survival status of the recipient, causes of death if the recipient died in the period since the last report, additional cellular infusions performed for the same indication, response to the cellular therapy, relapse, current hematologic findings, development of second or new malignancies, persistence of the cellular product depending on the product, development and severity of toxicities (e.g. cytokine release syndrome, neurotoxicity) and fertility information.

The Post-CTED Form must be completed at the following time points: 100 days, six months, and annually post-cellular therapy. The follow-up reporting schedule is determined by whether the product is genetically modified or not. The structure of the Post-CTED is such that each form should fit on a timeline with distinct start and stop dates that do not overlap any other forms, except in the case where an HCT is also received.

In scenarios where both HCT and cellular therapy forms are being completed, completion of this form should be based on the time period after cellular therapy infusion date (i.e. 100 days after the cellular therapy infusion date). Duplicate questions between HCT and cellular therapy forms may be disabled on the
Post-CTED.

Links to sections of form:
Q1: Product
Q2-3: Survival
Q4-8: Subsequent Cellular Infusions
Q9-11: Best Response to Cellular Therapy
Q12-15: Peripheral Blood Count Recovery
Q16-17: Disease Relapse or Progression
Q18-32: Current Hematologic Findings
Q33: New Malignancy, Lymphoproliferative or Myeloproliferative Disease/Disorder
Q34-56: Persistence of Cells
Q57-76: Graft vs. Host Disease
Q77-179: Toxicities
Q180-184: Infection
Q185-186: Functional Status

Sections of the Forms Instruction Manual are frequently updated. In addition to documenting the changes within each manual section, the most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.

Date Manual Section Add/Remove/Modify Description
11/18/2020 4100: Cellular Therapy Essential Data Follow-Up Modify Clarified reporting recipient death with new combined follow up rules.
11/17/2020 4100: Cellular Therapy Essential Data Follow-Up”:https://www.cibmtr.org/manuals/fim/1/en/topic/4100q175-179 Add Added clarification about prophylaxis drugs given to treat neurotoxicity: Indicate “yes” if the recipient received therapy for neurotoxicity and continue with question 130. Indicate “no” if no therapy was given for neurotoxicity and continue with question 132. Report any prophylactic drugs as therapy for neurotoxicity if they were continued after the date of diagnosis.
11/17/2020 4100: Cellular Therapy Essential Data Follow-Up Add Added clarification about prophylaxis drugs given to treat CRS: Indicate “yes” if the recipient received therapy for CRS and continue with question 81. Indicate “no” if no therapy was given for CRS and continue with question 83. Report any prophylactic drugs as therapy for CRS if they were continued after the date of diagnosis.
10/15/2020 4100: Cellular Therapy Essential Data Follow-Up Add Clarification added on the intent of this section for cell therapy versus the HCT.
10/7/2020 4100: Cellular Therapy Essential Data Follow-Up Remove Removed the note box above question 2, these questions are enabled for all cases: For scenarios where both HCT and CT forms will be submitted at the same time, there are duplicate questions across the F2100/2450 and F4100. To reduce the reporting burden, duplicated questions on the Cellular Therapy forms are disabled. This includes contact date and survival reported on F4100.
9/30/2020 4100: Cellular Therapy Essential Data Follow-Up Add The blue information box was added to question 2 to explain how to report the contact date for the D100 reporting period: If this form is being completed for the 1-year reporting period, ensure the reported contact date is ≥ Day 365.
8/27/2020 4100: Cellular Therapy Essential Data Follow-Up Add Blue information box added below question 77 to clarify how to report HLH/MAS: HLH/MAS is recognized as being part of the CRS spectrum. If the patient has developed HLH/MAS, please report “yes” for CRS and report any treatment given for HLH/MAS in question 80.
8/27/2020 4100: Cellular Therapy Essential Data Follow-Up Add Blue information box added below question 80 to clarify how to report HLH/MAS: HLH/MAS is recognized as being part of the CRS spectrum. If the patient has developed HLH/MAS, please report “yes” for CRS and report any treatment given for HLH/MAS in question 80.
8/27/2020 4100: Cellular Therapy Essential Data Follow-Up Add Blue information box added below question 145 to clarify how to report HLH/MAS: HLH/MAS is recognized as being part of the CRS spectrum, however, the option does not yet exist to report it under CRS. If the patient has developed HLH/MAS, please report it here as an “other toxicity”.
8/26/2020 4100: Cellular Therapy Essential Data Follow-Up Add Blue information box added above question 180 to clarify how to report COVID-19 infection when diagnosed after the start of the lymphodepleting therapy: Diagnosis of COVID-19 after the start of the lymphodepleting therapy: Any COVID-19 infections diagnosed after the start of the lymphodepleting therapy should be reported in questions 180 – 184 on the Cellular Therapy Essential Data Follow-Up (4100) form. An associated Respiratory Virus Post-Infusion Data (2149) form will be generated.
8/11/2020 4100: Cellular Therapy Essential Data Follow-Up Add Added the following blue information box (in red) above question 4:
For scenarios where both HCT and CT forms will be submitted at the same time, there are duplicate questions across the F2100/2450 and F4100. To reduce the reporting burden, duplicated questions on the Cell Therapy forms are disabled. This includes a subsequent cellular therapy infusion reported on F4100.
8/11/2020 4100: Cellular Therapy Essential Data Follow-Up Add Added the following blue information box (in red) above question 2:
For scenarios where both HCT and CT forms will be submitted at the same time, there are duplicate questions across the F2100/2450 and F4100. To reduce the reporting burden, duplicated questions on the Cellular Therapy forms are disabled. This includes contact date and survival reported on F4100.
7/24/2020 4100: Cellular Therapy Essential Data Follow-Up Modify Modified the date of contact instructions to reflect the new hard stop functionality associated with the Summer 2020 Form Release.
6/30/2020 4100: Cellular Therapy Essential Data Follow-Up Add Added the following note to reporting instruction for question 77-179: Report any observed toxicity or infection that occurs post-infusion that occurred in this reporting period, regardless of causality and whether or not treatment was administered (e.g chemotherapy due to relapse). The intent is to capture all toxicities diagnosed after the cellular therapy infusion. Although treatment given post-infusion may have the effect of re-activating the product and inducing toxicities (e.g. CRS), these toxicities should still be captured in this section of the form.
3/2/2020 4100: Cellular Therapy Essential Data Follow-Up Add Added the following sentence to reporting instruction for question 158-160: Other grade 4 toxicities / symptoms that are reported should be related to the cellular therapy infusion that are documented in the medical record as clinically important and relevant and do not fit into another category listed on this form.
3/2/2020 4100: Cellular Therapy Essential Data Follow-Up Add Added the following sentence to reporting instruction for question 151-153: Other grade 3 toxicities / symptoms that are reported should be related to the cellular therapy infusion that are documented in the medical record as clinically important and relevant and do not fit into another category listed on this form.
3/2/2020 4100: Cellular Therapy Essential Data Follow-Up Add Added the following sentence to reporting instruction for question 145-146: Other toxicities that are reported should be related to the cellular therapy infusion that are documented in the medical record as clinically important and relevant and do not fit into another category listed on this form.
2/6/2020 4100: Cellular Therapy Essential Data Follow-Up Modify Added table to display organ/system and applicable symptoms for grade 3 & 4 organ toxicities.
1/29/2020 4100: Cellular Therapy Essential Data Follow-Up Modify Clarified best response valid options in Table 1.
1/24/2020 4100: Cellular Therapy Essential Data Follow-Up Modify Version 5 section of the Forms Instruction Manual released. Version 5 corresponds to revision 5 of the Form 4100.
Last modified: Nov 18, 2020

Need more help with this?
Don’t hesitate to contact us here.

Was this helpful?

Yes No
You indicated this topic was not helpful to you ...
Could you please leave a comment telling us why? Thank you!
Thanks for your feedback.