Q46-65: Product Identification

Question 46: 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.

*Reporting More Than One Donor
Complete the donor specific questions to report more than one donor by adding an additional instance in the FormsNet3^SM application.

Question 47: 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.

• Autologous: Cells collected from the recipient for his / her own use.
• Allogeneic, related: A related donor who is a blood-related relative. This includes monozygotic (identical twins), non-monozygotic (dizygotic, fraternal, non-identical) twins, siblings, parents, aunts, uncles, children, cousins, half-siblings, etc.
• Allogeneic, unrelated: An unrelated donor who shares no known ancestry with the recipient. Include adoptive parents / children or stepparents / children.
  

Question 48: Did NMDP facilitate the procurement, collection, or transportation of the product?

Determine if NMDP facilitated the procurement, collection, and / or transportation of the product (i.e., the product from the donor being reported in this instance is an NMDP product or a non-NMDP product). Examples of non-NMDP donor registries include but are not limited to St. Louis Cord Blood Bank, Anthony Nolan, and StemCyte International Cord Blood Center. This information is included on the product label, the paperwork accompanying the product, and within NMDP search/product documentation.

If the documentation is unclear if NMDP facilitated the procurement, collection, and / or transportation of the product, seek clarification from the transplant coordinator.

If the recipient received a product facilitated by NMDP select Yes and report the NMDP cord blood unit ID or the GRID. Additionally, ensure the NMDP RID is reported on the CRID Assignment (2804) Form. For products facilitated by NMDP, the Registry or UCB Bank ID question will be disabled, and the Infectious Disease Markers (2004) and HLA Typing (2005) forms will not come due.

Below is a list of donor registries who were once “non-NMDP” registries but may now be an “NMDP-facilitated” registry:

• Matchis Foundation 71 (Netherlands)
• Hadassah Medical Organization 72 (Israel)
• Knochenmarkspenderzentrale – Dusseldorf 114 (Germany)
• The Tobias Registry of Swedish Bone Marrow Donors 119 (Sweden)
• The Norwegian Bone Marrow Donor Registry 120 (Norway)
• Welsh Bone Marrow Donor Registry 131 (Wales)
• British Bone Marrow Registry 134 (United Kingdom)
• Anthony Nolan 135 (United Kingdom)
• ZKRD 136 (Germany)

Question 49: 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.
• If the product was a related cord blood unit, report the non-NMDP CBU ID.
• If the product was an NMDP unrelated cord blood unit, report the NMDP CBU ID.
• If the product was a non-NMDP unrelated cord blood unit, report the non-NMDP CBU ID.

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

• If the autologous product was not a CBU, continue to Specify the total number of products.
• If the product was related and not a CBU, specify the related donor type, continue to Donor date of birth.
• If the unrelated donor was NMDP and not a CBU, continue to Global Registration Identifier for Donors (GRID).
• If the unrelated donor was non-NMDP and not a CBU, continue to Registry donor ID.

Question 50: Specify the related donor type (allogeneic, related only)

Indicate the relationship and match between the recipient and the related donor being reported in this instance. When determining the donor’s match / mismatched relationship to the recipient, only consider HLA-A, B, C, and DRB1.

• Syngeneic (monozygotic twin): 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.
• HLA-identical sibling (may include non-monozygotic twin): Non-monozygotic (dizygotic, fraternal, non-identical) twins. Occurs when two eggs are fertilized by two different sperm cells at the same time. Also includes siblings who aren’t twins but have identical HLA types. The recipient and donor will be allele level matched at HLA-A, B, C, and DRB1.
  • Does not include half-siblings (report as H*LA-matched other relatives* if their HLA typing is a match, or HLA-mismatched relative if it does not match).
• HLA-matched other relative (does NOT include a haplo-identical donor): All blood-related relatives, other than siblings, who are HLA matched (i.e., parents, aunts, uncles, children, cousins, half-siblings). The recipient and donor will be allele level matched HLA-A, B, C, and DRB1.
  • Does not include adoptive parents / children or stepparents / children who are HLA matched.
• HLA-mismatched relative (includes haplo-identical donor): Siblings who are not HLA-identical and all other blood-related relatives who have at least one HLA mismatch (mismatch can be at the antigen or allele level) (i.e.., parents, aunts, uncles, children, cousins, half-siblings). The recipient and donor will be antigen or allele level mismatched at 1 or more loci (HLA-A, B, C, or DRB1). Select this option for haploidentical transplants.
  • Does not include adoptive parents / children or stepparents / children.

Question 51: 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 52: 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 53: NMDP Cord Blood Unit ID

Report the NMDP Donor ID (e.g., 0000-0000-0). This ID is unique for each donor and is assigned by NMDP. This information is included on the product label, the paperwork accompanying the product, and within the NMDP search / product documentation.

Question 54: Registry ID (not applicable for related donors)

Report the non-NMDP unrelated donor ID. Examples of non-NMDP donor registries include Australia Bone Marrow Donor Registry and REDOME. This ID may be located on the product label, the paperwork accompanying the product, and registry-specific search / product documentation.

Question 55: 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 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.

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.

*ION and Affiliated to ION Available
If a registry or UCB bank has both an ION and an affiliated to ION, report the registry’s or UCB bank’s ION (not the affiliated to ION).

*Determining ION or Affiliated ION
To find an ION or affiliated ION visit WMDA.

Question 56-57: Registry or UCB Bank ID:

Specify the registry or umbilical cord blood (UCB) bank used to obtain the adult donor or umbilical cord blood unit. If Other Registry is selected, specify the four-digit ION or affiliated ION. If the registry or UCB bank does not have ION or affiliated ION, report the organization’s official name.

The World Marrow Donor Association (WMDA) ions have been adopted to avoid submitting the entire name and address when reporting the registry or UCB bank.

• ION: Issuing organization number allocated by International Council for Commonality in Blood Banking Automation (ICCBBA) in collaboration with the World Marrow Donor Association (WMDA)
• Affiliated ION: A registry or UCB bank may not have its own ION but is “affiliated to” a registry or UCB bank.
  • To find an affiliated ION
    • Navigate to the WMDA website
    • Use the ‘Filter’ to find the organization that provided the unit
    • The ‘affiliated to’ column will contain the affiliated ION (if one exists)

Review the diagram below when reporting the registry or UCB bank ID:

*Donor information
Donor date of birth/age and Donor sex should be answered only for related or non-NMDP donors. If the product is a cord blood unit or derived from a cord blood unit, the infant is the donor and not the mother.

Questions 58-59: 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.

Questions 60-61: 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. Report the age in months if the recipient is less than 1 year old, otherwise report the age in years.

Question 62: Donor sex

Indicate the donor’s sex. Sex shall refer to an individual’s immutable biological classification as either male or female. Sex is not a synonym for and does not include the concept of gender identity. For cord blood units, report the infant’s sex. Unknown should be used if the cell therapy product was “off the shelf” and/or the donor sex is not provided.

Question 63: Specify the total number of products (per protocol, as part of this course of cellular therapy)

*Breyanzi®
For infusions of Breyanzi® (both commercially available and non-conforming products), which has both CD4+ and CD8+ components, report both components as a single product, requiring a single Cellular Therapy Product (4003) Form.

Report the total number of products infused per protocol. This question is used to make the correct number of Cellular Therapy Product (4003) Forms 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 (4003) Forms.

Questions 64-65: Name of cellular therapy product (for more recent cellular therapy infusion)

*Commercially available products
Product specific reporting guides are available for Abecma®, Amtagvi®, Aucatzyl®, Breyanzi®, Carvykti® , Kymriah®, Tecartus®, Tecelra®, and Yescarta® on the CIBMTR Portal. The reporting guides contain product specific reporting instructions for completing CIBMTR cellular therapy forms.

*Out of spec or non-conforming products
Select the commercial product name for any commercial products that are part of an EAP trial or are out of spec.

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. If the product has no name, such as clinical trial or study product select No product name from the list.

*DLIs
Donor lymphocyte infusions (DLIs) should be reported on the Donor Lymphocyte Infusion (2199) form. Do not report a DLI as Other product.

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

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.