Question 3: Did the recipient receive a subsequent HCT since the date of last report?
Indicate whether the recipient received a second (or third, etc.) hematopoietic stem cell infusion. Hematopoietic stem cells are defined as mobilized peripheral blood stem cells, bone marrow, or cord blood. The source of the hematopoietic stem cells may be allogeneic unrelated, allogeneic related, or autologous. For more information on how to distinguish infusion types (example: HCT versus DCI), see Appendix D.
If the recipient has received a subsequent HCT since the date of the last report, ensure the date of actual contact reported in question 1 is the date immediately prior to the start of the preparative regimen for the subsequent HCT. If no preparative regimen was given, report the date prior to infusion.
Question 4: Date of subsequent HCT
Report the planned or actual date of the subsequent HCT infusion. If the planned date is reported and changes, this field will need to be updated to reflect the actual date of subsequent HCT infusion. If multiple days of infusion are planned, report the first.
Questions 5 – 6: What was the indication for subsequent HCT?
Indicate the reason for the subsequent HCT (check only one).
- Graft failure / insufficient hematopoietic recovery: Additional stem cells are required because there wasn’t any ANC recovery following HCT (primary graft failure), the hematopoietic recovery indefinitely declined after the initial hematopoietic recovery or hematopoietic recovery (secondary graft failure), or hematopoietic recovery was deemed insufficient or too slow for survival following previous high-dose therapy and HCT.
- If autologous cells are infused for this reason, this is considered an autologous rescue; in this case, reporting will continue under the prior HCT date and a new Pre-TED form is not required.
- If allogeneic cells are infused, this would be considered a subsequent HCT and a new Pre-TED is required and reporting would start over.
- Persistent primary disease: Additional stem cells are required because of the persistent presence of disease pre- and post-transplant (i.e., complete remission was never achieved following the previous transplant).
- Recurrent primary disease: Additional stem cells are required because of relapsed primary disease (i.e., complete remission was achieved pre or post-transplant, but the disease relapsed following the previous transplant).
- Planned subsequent HCT, per protocol: Additional stem cells are given as defined by the protocol for a subsequent transplant / infusion. This transplant is not based upon recovery, disease status, or any other assessment.
- New malignancy (including PTLD and EBV lymphoma): Additional stem cells are required because the recipient has developed a new malignancy. This does not include a transformation or progression of the original malignancy for which the recipient was transplanted. If New malignancy is selected, also complete the New Malignancy, Lymphoproliferative or Myeloproliferative Disorder section of the form.
- Insufficient chimerism: In the case of a stable, mixed donor chimerism, the infusion of additional cells (usually lymphocytes and not mobilized stem cells) is typically classified as a DCI. Verify with the transplant physician that the cells given should be reported as a subsequent transplant and that stable, mixed chimerism is the reason for the transplant. However, in the case of declining chimerism – when the percentage of donor cells is sequentially decreasing on several studies, indicating possible impending graft failure – additional stem cells are required. Usually the donor chimerism has fallen below 30-50%.
- Other: If additional stem cells are given for a reason other than the options listed, select Other and specify.
Question 7: Source of HSCs (check all that apply)
Report the stem cell source(s) of the recipient’s subsequent HCT. All allogeneic sources, and autologous sources with indication other than “graft failure / insufficient hematopoietic recovery”, will require another Pre-TED form to be completed for the subsequent HCT.
Question 8: Has the recipient received a cellular therapy since the dat of last report? (e.g., CAR-T, DCI)
Indicate whether the recipient received a cellular therapy for any reason within the reporting period. The most common type of post-HCT cellular therapy would be a donor cellular infusion (DCI) or donor lymphocyte infusion (DLI). These infusions are not intended to promote hematopoiesis. If the recipient received additional cells due to engraftment issues, or if they received an infusion of unmanipulated CD34+ cellular product (stimulated peripheral blood stem cells, bone marrow, or cord blood), report as a subsequent HCT rather than a cellular therapy. For more information on how to distinguish infusion types (example: HCT versus DCI), see “Appendix D.
A DCI is a form of cellular therapy that uses cells from the original donor, and is commonly used to create a graft-versus-leukemia / tumor (GVL / GVT) effect. The recipient does not receive a preparative regimen prior to receiving the donor cells because the purpose of a DCI is to activate the immune system rather than repopulate the marrow. The recipient may, however, be given therapy prior to the infusion for the purpose of disease control. The types of cells used in a DCI include, but are not limited to: lymphocytes, unstimulated peripheral blood mononuclear cells, dendritic cells, and / or mesenchymal cells.
Other forms of cellular therapy may include cytotoxic T-lymphocytes (CTLC) to treat infections or chimeric antigen receptor T-cells (CAR T-cells) to treat persistent, progressive or recurrent disease.
Question 9: Was this infusion a donor lymphocyte infusion (DLI)?
As previously mentioned, donor lymphocyte infusions (DLI) are considered a type of cellular therapy. These infusions are not intended to promote hematopoiesis. If the recipient received additional cells due to engraftment issues, or if they received an infusion of unmanipulated CD34+ cellular product (stimulated peripheral blood stem cells, bone marrow, or cord blood), report as a subsequent HCT rather than a cellular therapy. For more information on how to distinguish infusion types (example: HCT versus DCI), see Appendix D.
Indicate if the infusion was a donor lymphocyte infusion (DLI). An infusion is donor lymphocyte infusion when all the following criteria are met:
• The intent of the infusion is something other than to restore hematopoiesis
• The infusion must be post-Allogenic HCT, often by the same donor as the HCT
• The product must be a lymphocyte product
• The product cannot be genetically modified
If the infusion meets the above definition of DLI, select Yes and complete the Donor Lymphocyte Infusion (2199) form instead of the Cellular Therapy Essential Data Pre-Infusion (4000) Form.
If the infusion does not meet DLI criteria, select No.
Question 10: Number of DLIs in this reporting period
Report the number of Donor Lymphocyte Infusions (DLI) the recipient received in the reporting period. This question is used to make the correct number of Donor Lymphocyte Infusion (2199) Forms come due.
Question 11: Are any of the products, associated with the course of cellular 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). Donor Lymphocyte infusions are typically not genetically modified.
Report Yes if the product associated with the course of cell therapy being reported in this instance is genetically modified. This question is used to determine the follow up schedule of the cellular therapy.
Question 12: Date of cellular therapy
Report the date of cellular therapy infusion. If the new course of cellular therapy includes multiple infusions, report the date of the first infusion. If infusions are continuing from a previous instance of a course of cellular therapy, only report in the period during which the first infusion was received. This question is used to make the Pre-CTED (4000) form come due and is not answered for DLIs.
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