This form must be completed for all recipients of cellular therapy (non-HCT), including post-HCT DCI infusions. For recipients of hematopoietic cellular transplants, complete the appropriate HCT follow-up form. For recipients of Donor Lymphocyte Infusions (DLI), complete the Donor Lymphocyte Infusion (2199) form
The Post-Cellular Therapy Essential Data (Post-CTED) follow-up form focuses on key follow-up information for each reporting period, 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, response to the cellular therapy, relapse, current hematologic findings, development of new malignancies, persistence of the cellular product (product specific), development and severity of toxicities (e.g. cytokine release syndrome, neurotoxicity), infection and fertility information.
The Post-CTED Form must be completed at the following time points post-cellular therapy: 100 days, six months, and annually thereafter. 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.
Combined follow up
In scenarios where both HCT and cellular therapy forms are being completed, there are two scenarios where the Cellular Therapy Essential Data Follow-Up (4100) form is completed:
Example 1. Cellular therapy after HCT: completion of this form should be based on the time period in relation to the CT infusion date (i.e., 100 days after the CT infusion date). The visit ID and date of contact should match between the corresponding Post-HSCT Data (2100) or Post-Transplant Essential Data (2450).
Example 2. HCT after cellular therapy: completion of this form should be based on the time period in relation to the HCT infusion date (i.e., 100 days after the HCT infusion date). The visit ID and date of contact should match between the corresponding Post-HSCT Data (2100) or Post-Transplant Essential Data (2450).
Duplicate questions between HCT and cellular therapy forms may be disabled on the Post-CTED. A full list of enabled/disabled fields can be found on the “Subsequent Infusions – Updates to Follow-Up Reporting section of the Data Management Guide. Illustrations of the combined follow up scenarios can also be found the Guide.
Q4-8: Subsequent Cellular Infusions
Q9-11: Best Response to Cellular Therapy
Q12-20: Peripheral Blood Count Recovery
Q21-22: Disease Relapse or Progression
Q23-33: Current Hematologic Findings
Q34: New Malignancy, Lymphoproliferative or Myeloproliferative Disease/Disorder
Q35-59: Persistence of Cells
Q60-79: Graft vs. Host Disease
Q176-177: Pregnancy 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.
|11/15/2022||Modify||Clarified how to report a fever documented from a home test: Fevers (≥100.4F or ≥38C): A disorder characterized by elevation of the body’s temperature above the upper limit of normal. Do not report fever if less than 100.4F or 38C in this field. Fever less than 100.4F or 38C does not qualify as a symptom of CRS. Report the date of fever onset in question 87. If there were multiple fevers in the reporting period, report the first occurrence. If the recipient self-reported a fever from a home test, and the date is documented in the medical records, report the date of the home test.|
|10/17/2022||4100 Post-CTED||Modify||Updated the continue with question number: If the reason for the new course of cellular therapy was Failure to respond or in response to disease assessment or for a New indication, continue with question 10
|10/10/2022||4100 Post-CTED||Modify||Clarified in questions 92-94 what not to report for other CRS therapy (in red): Examples of what not to report as other therapy include, but are not limited to, acetaminophen (Tylenol®) albumin, antibiotics, IV fluids, or any brand name or specific corticosteroids administered.|
|10/10/2022||4100 Post-CTED||Modify|| Clarified in questions 95-105 what not to report for other hypotension therapy (in red): Examples of what not to report as other therapy include, but are not limited to, acetaminophen (Tylenol®) albumin, antibiotics,
|9/23/2022||4100: Post-CTED||Modify|| Updated for new DLI reporting process: This form must be completed for all products for recipients of non-HCT cellular therapy (including post-HCT DCI
|4/11/22||4100 Post-CTED||Add|| Clarification added on reporting COVID-19 infections for subsequent infusions & possible reporting scenarios: Do NOT report an infection in the following scenarios:
A recipient only has a positive antibody result.
The recipient was symptomatic and treated but COVID-19 diagnostic testing was not performed and / or COVID-19 diagnostic testing was performed and negative.
DO report an infection in the following scenarios:
A recipient has a positive COVID-19 diagnostic result (PCR or antigen) or if treatment was given or if the recipient was asymptomatic.
A recipient has a positive antibody result and a positive COVID-19 diagnostic test (PCR or antigen)
|4/11/2022||4100 Post-CTED||Add||COVID-19 Reinfection blue box added above Q204-208: Reporting COVID-19 Reinfection: There have been cases of recipients recovering from COVID-19 infection, only to later test positive again. For CIBMTR purposes, a new COVID-19 infection should be reported when a recipient tests positive again >21 days from resolution (resolution defined as no signs or symptoms of infection, or a negative diagnostic test).||Added for clarification|
|4/11/2022||4100: Q204-213: Infection||Add||COVID-19 Reinfection blue box added above Q204-208: Reporting COVID-19 Reinfection: There have been cases of recipients recovering from COVID-19 infection, only to later test positive again. For CIBMTR purposes, a new COVID-19 infection should be reported when a recipient tests positive again >21 days from resolution (resolution defined as no signs or symptoms of infection, or a negative diagnostic test).|
|4/11/2022||4100: Q204-213: Infection||Add||Clarification added in regard to revaccination post-infusion: Indicate if the recipient received a vaccine for COVID-19 (one dose without a planned second dose, first dose with planned second dose, second dose, third dose, and / or booster dose) within the current reporting period. If the recipient did not receive a vaccine for COVID-19 or it is not known if the recipient received a vaccine, select No or Unknown, respectively, and continue with question 214. Revaccination Post-Infusion: When vaccines are given post-infusion, the physician should make the determination on whether the doses are part of the primary series of vaccines, third primary dose, boosters, or revaccination. If a recipient receives a new course of COVID vaccines following infusion as revaccination, report the vaccines as a new series. The most up to date CDC COVID-19 vaccine information for immunocompromised people can be found here.|
|4/11/2022||4100: Q204-213: Infection||Modify|| Updated blue box above Q210-211 how to report multiple vaccine doses: COVID-19 Vaccine Doses
FormsNet3SM application: Complete questions 210 – 213 to report all COVID-19 vaccine doses received in the current reporting period by adding an additional instance in the FormsNet3SM application. A separate instance should be added for each dose.
|4/11/2022||4100: Q204-213: Infection||Modify/Add|| Updated question instructions: For the reported dose, specify the vaccine brand the recipient received. If the vaccine brand is not listed, select Other type and specify. If the vaccine brand is unknown, leave the field blank and override the error as Unknown. Third dose versus Booster dose blue box added above question 210-211: Third dose versus Booster dose: To determine between a third dose and a booster dose, seek clinician clarification, as needed, using the guidelines listed below:
Third dose: An additional primary dose required for recipients who did not build enough protection from their primary vaccine series, typically for immunocompromised individuals
Booster dose: Administered to recipients who have enough protection after completing their primary vaccine series but then protection decreases over time
Primary vaccine series: Two doses of Pfizer-BioNTech or Moderna One dose of Johnson & Johnson’s Janssen.
|4/11/2022||4100: Q204-213: Infection||Modify||Updated question instructions: For the reported dose, specify the vaccine dose the recipient in the current reporting period and specify the date when the dose was received|
|4/11/2022||4100: Q89-202: Toxicities”||Add||Additional example (#5) added to clarify hypogammaglobulinemia reporting: Example 5. For an adult recipient, IgG levels were below 600 mg/dL pre-infusion and immunoglobulin replacement therapy (IVIG) was given pre-infusion. Post-infusion, all IgG values were greater than 600 mg/dL and never dropped below 600 mg/mL. This is not reported as a toxicity since the IgG levels were never below 600 mg/dL after infusion.|
|1/28/2022||4100: Cellular Therapy Essential Data Follow-Up||Modify||Version 8 of the 4100: Cellular Therapy Essential Data Follow-Up section of the Forms Instruction Manual released. Version 8 corresponds to revision 8 of the Form 4100.|
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