Question 33: Are any of the products associated with this course of cell therapy genetically modified?

Genetically modified products include any product that was manipulated to alter its gene expression through the insertion of different genes or editing of genes. An example of a genetically modified product is the manipulation of T-lymphocytes to express Chimeric Antigen Receptors (CAR T-cells) directed towards specific tumor targets (antigens). If more than one product is infused, indicate if any of the products are genetically modified. This question is used to determine the follow up schedule of the cellular therapy.

Questions 34-53 Reporting Donor Information
FormsNet3SM application: Complete questions 34-53 to report all donors, per protocol, by adding an additional instance in the FormsNet3SM application.
Paper form submission: Copy questions 34-53 and complete for all donors, per protocol.

Question 34: Specify donor:

Indicate the donor type for this product. If the product is “off the shelf” or a “third party” donor product obtained from pharmaceutical companies or other corporate entities, donor type should still be identified.

An Autologous product has cells collected from the recipient for his / her own use.

A related donor (Allogeneic, related) is a blood-related relative. This includes syngeneic, monozygotic (identical) twins, non-monozygotic (dizygotic, fraternal, non-identical) twins, siblings, parents, aunts, uncles, children, cousins, half-siblings, etc. Do not include adoptive parents/children or stepparents/children.

An unrelated donor (Allogeneic, unrelated) is a donor who shares no known ancestry with the recipient. Include adoptive parents/children or stepparents/children.

Question 35: Did NMDP/Be the Match facilitate the procurement, collection, or transportation of the product?

Indicate whether NMDP / Be the Match facilitated the procurement, collection, or transportation of the product. This information is included on the product label, the paperwork accompanying the product, and within the NMDP search / product documentation.

Question 36: Was the product a cord blood unit?

Indicate Yes if the product was a cord blood unit or was derived from a cord blood unit.

  • If the product was an autologous cord blood unit, report the non-NMDP CBU ID in question 41.
  • If the product was a related cord blood unit, report the non-NMDP CBU ID in question 41.
  • If the product was an NMDP unrelated cord blood unit, report the NMDP CBU ID in question 39.
  • If the product was a non-NMDP unrelated cord blood unit, report the non-NMDP CBU ID in question 41.

Indicate No if the product was not a cord blood unit.

  • If the autologous product was not a CBU, continue with question 50.
  • If the product was related and not a CBU, specify the related donor type in question 37 then continue with question 45 to report donor date of birth.
  • If the unrelated donor was NMDP and not a CBU, report the GRID in question 42.
  • If the unrelated donor was non-NMDP and not a CBU, report the non-NMDP unrelated donor ID in question 40.

Question 37: Specify the related donor type (allogenic, related only)

Indicate the relationship and match between the recipient and the related donor reported in this instance.

Syngeneic:
Includes: Monozygotic (identical) twins. Occurs when a single egg is fertilized to form one zygote, which then divides into two separate embryos.
Does not include: Other types of twins or HLA-identical siblings (see below).

HLA-identical sibling:
Includes: Non-monozygotic (dizygotic, fraternal, non-identical) twins. Occurs when two eggs are fertilized by two different sperm cells at the same time. This category also includes siblings who aren’t twins but have identical HLA types. The patient and donor will be allele-level matched at HLA-A, B, C, and DRB-1.
Does not include: Half-siblings should be reported as “HLA matched other relative”, if their HLA typing is a match, or “mismatched relative” if it does not match.

HLA-matched other relative:
Includes: All blood relatives, other than siblings, who are HLA matched (e.g., parents, aunts, uncles, children, cousins, half-siblings). The patient and donor will be allele-level matched at HLA-A, B, C, and DRB-1.
Does not include: Adoptive parents/children or stepparents/children who are HLA matched.

HLA-mismatched relative:
Includes: Siblings who are not HLA-identical and all other blood- relatives who have at least one HLA
mismatch (mismatch can be at the antigen or allele level) (e.g., parents, aunts, uncles, children, cousins, half-siblings). The patient and donor will be allele-level mismatched at one or more loci (HLA-A, B, C, or DRB-1).
Does not include: Adoptive parents/children or stepparents/children.

Question 38: Was this donor used for any prior cellular therapies or HCT? (for this recipient)

Indicate if the allogeneic unrelated or related donor reported in this instance was used for prior cellular therapies or HCT for this recipient. If this is the recipient’s first infusion, select No.

Question 39: NMDP Cord Blood Unit:

Report the NMDP unrelated cord blood unit ID. This information is included on the product label, the paperwork accompanying the product, and within the NMDP search/product documentation. The ID is always numeric and begins with “9” (e.g., 9000-0000-0). If the product ID does not begin with a “9,” the product may not be an NMDP cord blood unit and the source of the product should be double-checked. Enter the NMDP unrelated cord blood unit ID.

Question 40: Non-NMDP unrelated donor ID: (not applicable for related donors)

Report the non-NMDP unrelated donor ID. Examples of non-NMDP donor registries include, but are not limited to: Anthony Nolan, Australia Bone Marrow Donor Registry, and REDOME. This ID is often located on the product label, the paperwork accompanying the product, and registry-specific search/product documentation. Enter the non-NMDP unrelated donor ID.

Question 41: Non-NMDP cord blood unit ID: (include related and autologous CBUs)

Report the non-NMDP cord blood unit ID. Examples of non-NMDP donor registries include but are not limited to: St. Louis Cord Blood Bank and StemCyte International Cord Blood Center. This ID is often located on the product label, the paperwork accompanying the product, and registry-specific search/product documentation. Enter the non-NMDP cord blood ID.

Note that some cord blood banks can ship their units either through the NMDP or directly to the transplant center. Carefully review the accompanying documentation to determine which is appropriate for your unit. You may wish to consult with your center’s Transplant Coordinator, as he or she will have insight as to how the product was acquired.

Question 42: Global Registration Identifier for Donors (GRID):

The Global Registration Identifier for Donors (GRID) was developed by the WMDA to ensure secure, reliable and unambiguous assignment of unrelated donors. The GRID standard is a 19-character donor identifier composed of three elements: Issuing Organization Number (ION), Registration Donor Identifier, and Checksum (shown below). This standard will ensure each donor ID is globally unique and will reduce the risk of misidentification of donors or their donations.


https://www.wmda.info/professionals/optimising-search-match-connect/why-global-identifier/

Question 43-44: Registry or UCB Bank ID:

Report the registry or UCB Bank ID used to obtain the adult donor or umbilical cord blood unit.

The Bone Marrow Donors Worldwide (BMDW) codes have been adopted to avoid submitting the entire name and address of the donor registry. Some common banks that do not list with BMDW have been added to the FormsNet3 list, including St Louis Cord Blood Bank (SLCBB) and Viacord (VIAC).

The registry code for NMDP donors is USA1 and for NMDP cord units is U1CB.

If the donor was found through DKMS, report the registry that facilitated the HCT. Some registries may be listed more than once with BMDW (one way for marrow/PBSC products and differently for cord blood products). Ensure that the appropriate code for the product was selected because distribution of data depends on the code.

If the BMDW website does not list a match code for the adult donor registry or cord blood bank, provide the registry’s official name in question 44. Ensure the entered registry in question 44 is not already listed in the pull-down list for question 43. For example, NMDP adult donors, NMDP cords, and New York Cord Bank each have their own entries above in the registry or UCB Bank ID drop down menu.

Question 45-46: Donor date of birth:

Report if the donor’s date of birth is Known or Unknown. If the donor’s date of birth is known, report the date of birth (YYYY-MM-DD) in question 46 and continue with question 49.

Question 47-48: Donor age:

If the donor’s DOB is unknown, report if the donor’s age is Known or Unknown. If the donor’s age is known, report the donor’s age at the time of product collection in question 48. Report the age in months if the recipient is less than 1 year old, otherwise report the age in years.

Question 49: Donor sex:

Indicate the donor’s biological sex as Male or Female. For cord blood units, report the infant donor’s sex.

Question 50: Specify the total number of products: (per protocol, as part of this course of cellular therapy)

Report the total number of products infused per protocol. This question is used to make the correct number of Cellular Therapy Product Forms (Form 4003) come due. Each product must be part of the protocol and will be given regardless of disease response.

Example 1. A series of collections from the same donor that uses the same collection method even if the collections are performed on different days, should be considered a single cellular therapy product if only one set of manufacturing steps are applied to the collected material.

Example 2. Products from the same donor but obtained using different manufacturing steps are considered different products and require multiple product forms.

Example 3. If the cells were manipulated or modified by different methods and at the end of the manufacturing process are combined for a single infusion or administration, it will be considered a single product and it will require a single Cellular Therapy Product Forms (Form 4003).

Example 4. A single collection from the donor is separated into two portions. One portion is the cells for a DLI that are infused the same day. The second portion is selected and expanded for NK cells and then infused the next day. This is considered two products, each requiring a Cellular Therapy Product Forms (Form 4003).

Question 51: Does your center consider this infusion to be a donor lymphocyte infusion (DLI)?

Indicate whether this course of cellular therapy is considered to be a DLI at your center. An infusion can be classified as a “DLI” when:

  • The intent is something other than to restore hematopoiesis
  • The infusion must be post-HCT, often by the same allogeneic donor as the HCT
  • Indication is suboptimal donor chimerism, immune reconstitution, GVHD treatment, prevent or treat disease relapse
  • Composition of cells is lymphocytes

Infusions that are given with the intent to engraft should be reported as an HCT and complete the Pre-TED (2400) and Disease Classification (2402) forms.

Question 52-53: Name of product:

This question is limited to commercially available or pre-commercial products and is used for study enrollment and validation. If the name of the product is not an option, select Other product and specify the name in question 53. If the product has no name, such as clinical trial or study product select No product name from the list.

The product name selected here will be auto populated onto subsequent forms and used to disable questions where the information is not made available to sites (i.e. manufacturing or cell dose).

Question 54: In what setting is this cell therapy product infusion being planned?

Indicate if this cell therapy product infusion will be administered as an Inpatient or Outpatient procedure.

Question 55: Is a subsequent HCT part of the overall treatment protocol?

This question intends to capture instances where the cellular therapy is administered in association with an HCT, either planned or dependent upon the response to the cellular therapy. It is not intended to capture an HCT given prior to this cellular therapy infusion. If, at the time of the current infusion, a subsequent HCT is planned according to the protocol, check Yes even if the recipient does not receive the planned subsequent HCT. The word “planned” should not be interpreted as: if the recipient relapses, then the “plan” is to perform a subsequent HCT. If a subsequent HCT is not planned as part of the overall treatment protocol, select No and continue with question 58.

Question 56: Specify the HCT type:

Specify the type of the subsequent HCT that is planned as part of the overall treatment protocol.

  • Autologous product has cells collected from the recipient for his / her own use.
  • Allogeneic product is from a donor who is not the recipient, either related or unrelated to the recipient.

Question 57: Specify the circumstances which the subsequent HCT will be performed:

Specify the reason for which the subsequent HCT will be performed as Regardless of response to cellular therapy, Only if the patient responds to cellular therapy, or Only if the patient fails to respond or has an incomplete response.

Section Updates:

Question Number Date of Change Add/Remove/Modify Description Reasoning (If applicable)
. . . . .
Last modified: Jan 22, 2021

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