Q5 – 39: Donor Cellular Infusion (DCI)

Question 5: Date of this DCI

Report the date when the DCI being reported on this form was infused. If the product was infused over multiple days, report the first date of infusion.

If the exact date is unknown, review General Instructions, General Guidelines for Completing Forms for more information on reporting partial and unknown dates.

!Insufficient Hematopoietic Recovery / Graft Failure
The Insufficient hematopoietic recovery / graft failure indication is applicable for allogeneic boost infusions and not DLIs.

Questions 6 – 7: What was the primary indication?

From the list provided, select the primary indication for which the recipient is receiving the DCI. If the primary indication is unclear, seek clinician clarification.

These indications are given with HCT or post-HCT. No additional consent is required from the recipient per CIBMTR. Confirm with the center’s local IRB if reconsent is necessary.

If Other indication is selected, specify the indication.

Question 8: What therapy to treat disease given prior to the DCI?

This question is intended to capture if the recipient received disease treatment prior to the DCI. Indicate if therapy to treat disease was given prior to the DCI. Do not include preparative regimen or bridging therapy.

If Yes, and the recipient is on CRF track for the HCT, ensure all lines of therapy are reported on the post-infusion disease specific form.

!CBC Not Completed Prior to Infusion
In the rare case where the CBC was not assessed at any time prior to the DCI, leave Date complete blood count sample drawn through Were platelets transfused < 7 days before the date of the sample was drawn questions blank and override the FormsNet3^SM.

Question 9: Date complete blood sample drawn (CBC)

These questions are intended to determine the clinical status of the recipient prior to the infusion. Report the date of the most recent CBC prior to infusion. Typically, no systemic therapy (therapy not for treatment of disease, but analogous to preparative regimen) is given prior to DLIs or allogeneic boosts. However, if systemic therapy was administered, report the date of the CBC prior to systemic therapy. The CBC from the first day of the systemic therapy may be reported as long as the blood was drawn before any systemic therapy was administered.

Questions 10 – 18: Complete blood count results available (check all that apply)

Select all cells assessed on the reported CBC date above.

• WBC: The white blood cell count is a value that represents all the white blood cells in the blood. If the count is too high or too low, the ability to fight infection may be impaired. If the WBC was assessed on the reported CBC date, report the value and units of measurement.
• Neutrophils: Neutrophils are a subtype of white blood cell that fights infection. The value on the laboratory report may be a percentage or an absolute value. If an absolute value is reported, divide it by the white blood cell count for a percentage. Neutrophils are also known as polymorphonuclear leukocytes (PMNs). If neutrophils were assessed on the reported CBC date, report the percentage.
• Lymphocytes: Lymphocytes are another subtype of white blood cell that fights infection. The value on the laboratory report may be a percentage of an absolute value. If an absolute value is reported, divide it by the white blood cell count for a percentage. If lymphocytes were assessed on the reported CBC date, report the percentage.
• Hemoglobin: Hemoglobin is a molecule in red blood cells that delivers oxygen to tissues throughout the body. A low hemoglobin count value is considered “anemia” and blood transfusions, or growth factors may be required to increase the hemoglobin level. If the hemoglobin was assessed on the reported CBC date, report the value and units of measurement.
• Hematocrit: The hematocrit is the percentage (sometimes displayed as a proportion) of red blood cells relative to the total blood volume. Low hematocrit may require red blood cell transfusions or growth factors. Indicate if the recipient received a red blood cell transfusion within 30 days prior to sample draw date. If hematocrit were assessed on the reported CBC date, report the percentage. Additionally, indicate if the recipient received red blood cell transfusion(s) within 30 days prior to the date of the CBC reported above.
• Platelets: Platelets are formed elements within the blood that help with coagulation. A low platelet count, called thrombocytopenia, may lead to easy bleeding or bruising. Thrombocytopenia may require platelet transfusions. If platelets were assessed on the reported CBC date, report the value and units of measurement. Additionally, indicate if the recipient received platelet transfusion(s) within seven days prior to the date of the CBC reported above.
  

*Performance Scores
Refer to Appendix L: Karnofsky / Lansky Performance Status for more information on reporting performance scores.

Question 19: What scale was used to determine the recipient’s functional status prior to the donor cellular infusion?

The CIBMTR uses the Karnofsky / Lansky scale to determine the functional status of the recipient immediately prior to the start of lympho-depleting therapy / systemic therapy or infusion. The Karnofsky Scale is designed for recipients aged 16 years and older and is not appropriate for children under the age of 16. The Lansky Scale is designed for recipients one year old to less than 16 years old.

Report the scale used to determine the recipient’s functional status prior to the start of lympho-depleting therapy / systemic therapy or infusion.

For recipients less than one year old, the Performance score questions should be left blank.

Questions 20 – 21: Performance score

Report the recipient’s performance status immediately prior to the start of lympho-depleting therapy / systemic therapy or infusion. For the purposes of this manual, the term “immediately prior” represents the pre-infusion work-up phase, or approximately one month prior to the start of the lympho-depleting therapy or systemic therapy.

If a Karnofsky / Lansky score is not documented in the source documentation (e.g., inpatient progress note, physician’s clinic note), data management professionals should not assign a performance score based on analysis of available documents. Rather, a physician or mid-level health care provider (NPs and PAs) should provide documentation of the performance score. Documentation from an RN who has been trained and authorized to determine performance scores may also be used.

If only an ECOG is documented, convert the ECGO score to Karnofsky / Lansky. Refer to Appendix L: Karnofsky / Lansky Performance Status and / or the memorandum and worksheet example found in Appendix L: Karnofsky / Lansky Performance Status of the ‘Appendices’ section located in the Retired Forms Manuals webpage.

Questions 22 – 23: Date of cell product collection

Indicate if the date of cell product collection is Known. If Known, report the date. If the cell product is collected over multiple days, report the first date when collection began.

If the exact date is not known, refer to General Instructions, General Guidelines for Completing Forms for more information regarding reporting partial or unknown dates.

Question 24: Was the product previously cryopreserved?

The intent of this question is to capture if the product was ever cryopreserved (i.e., cells used for the DCI are left over from a prior infusion, cells were collected specifically for the DCI and cryopreserved before the DCI infusion, etc.). Indicate if the DCI product was previously cryopreserved.

Questions 25 – 26: Tissue Source

Select from the list the tissue source(s) of the cellular product for this infusion. If the source is selected as Other tissue source, specify the other source.

The tissue source for non-mobilized peripheral blood, peripheral blood apheresis, and MNCs should be reported as Peripheral blood.

!Genetic Modification
The infusion types captured on this form cannot be genetically modified.
• Any cell therapy product that is genetically modified must be reported on a Pre-CTED (4000) as a cellular therapy and requires 15 years of follow-up.
• Any HCT product that is genetically modified must be reported on a Pre-TED (2400) & Disease Classification (2402) form and requires 15 years of follow-up.
Contact CIBMTR Center Support if corrections are required

Question 27: Were the cells in the infused product selected / modified / engineered / manipulated prior to infusion?

Indicate if the cells selected were (i.e., selective retention of a population of desired cells through recognition of specified characteristics), modified, engineered and / or manipulated prior to infusion.

*Steps in Manipulation
If the manipulation consists of several steps, individual steps do not need to be reported as separate manipulations. For example, T-cell depletion that is part of expansion, does not need to be reported.

*Cryopreservation as a Manipulation
Do not report cryopreservation (including plasma removal as part of cryopreservation) as a method of manipulation.

Questions 28 – 29: Specify the method(s) used to manipulate the product (check all that apply)

Specify the method(s) of manipulation. Check all that apply.

• Cultured (ex-vivo expansion): cells placed in culture to increase in number (i.e., to expand) allowing for sufficient cells for infusion.
• Induced cell differentiation: cells placed in culture to give rise to cellular elements with biological characteristics other than those of the cells being cultured (i.e., mesenchymal stromal cells cultured to make osteoblasts; pluripotent stem cells cultured to make neural cell precursors). Usually, the description of the process would include the term “differentiation of cells X into cells Y”. This scenario can be seen in regenerative medicine indications.
• Cell selection – positive: the manipulation of a cellular therapy product such that a specific cell population(s) is enriched. This may be achieved by using an antibody that binds to a specific population of cells (e.g., CD4+ selection).
• Cell selection – negative: the manipulation of a cellular therapy product such that a specific cell population(s) is reduced.
• Cell selection based on affinity to a specific antigen: the cellular product undergoes selection to isolate the target population based on the ability of the target population to bind or recognize a specific antigen (e.g., a T cell population recognizing viral proteins, or a protein associated with cancer).
  

Select Other cell manipulation if the manipulation is not listed above and specify.

*Product Infusion
The cell type(s) administered should be for a single DCI. If multiple DCIs were given in the reporting period, each DCI should be reported on a separate Donor Cellular Infusion (2199) Form.

Questions 30 – 37: Specify the cell type(s) administered (check all that apply)

Select the cells infused with current DCI. Check all that apply.

• CD34+ cells: Also known as hematopoietic stem cells. If administered, report the total number of CD34+ cells infused. Report the absolute number of cells, not cells per kg.
• Lymphocytes (unselected): Unselected means a specific lymphocyte sub-population (e.g. CD4+) was not targeted. This includes all types of lymphocytes, those that have not been selected via flow cytometry or other methods. If administered, report the total number of unselected lymphocytes infused. Report the absolute number of cells, not cells per kg.
• CD4+ lymphocytes: The lab report may display this value as CD3+CD4+. These cells are also known as T-helper cells. If administered, report the total number of CD4+ cells infused. Report the absolute number of cells, not cells per kg.
• CD8+ lymphocytes: The lab report may display this value as CD3+CD8+. These cells are also known as cytotoxic T-cells which can destroy virus-infected cells, tumor cells, tissue grafts, etc. If administered, report the total number of CD8+ cells infused. Report the absolute number of cells, not cells per kg.
• Regulatory T-cells (TREG): TREG cells express the biomarkers CD4, FOXP3, and CD25. If administered, report the total number of TREG cells infused. Report the absolute number of cells, not cells per kg.
  

Select Other cell type if cell type infused is not listed above, specify the other cell type, and report the total number infused. Report the absolute number of cells, not cells per kg.

Question 38: What was the best response to the DCI?

This question is intended to collect the recipient’s best response to the DCI. If the recipient received a prior HCT, do not report the response to HCT. A separate evaluation to establish the best response after the DCI is required.

Specify the recipient’s best response to the DCI. For DLIs, report the best response was achieved within 30 – 60 days post-infusion. Use Table 1 below to review the applicable response options by indication and the best response definitions.

If an assessment was not completed after the DCI, select Not assessed.

Table 1. Best Response Definitions by Indication

Indication	No Response	Disease Progression	Partial Response	Complete Response	Partial Normalization of Blood Count	_.Normalization of Blood Count
GVHD Prophylaxis	Best response not answered	Best response not answered	Best response not answered	Best response not answered	Best response not answered	Best response not answered
GVHD Treatment	Does not meet partial response or complete response	–	Improvement but not resolution of symptoms, remains on immune suppression	Resolution of symptoms and off immune suppression	–	–
Immune Reconstitution	Does not meet complete response	–	–	CD3 > 200/mm3	–	–
Infection Treatment	Does not meet partial response or complete response	–	Decrease in infectious burden without resolution	Undetectable infection	–	–
Insufficient Hematopoietic Recovery / Graft Failure	Does not meet partial normalization or normalization of blood count	–	–	–	One or two of the cell lines (WBC, RBC, and platelet) return to normal levels	All three cell lines (WBC, RBC, and platelet) return to normal levels, or at grade 1 cytopenia
Prevent Disease Relapse	Best response not answered	Best response not answered	Best response not answered	Best response not answered	Best response not answered	Best response not answered
Suboptimal Donor Chimerism	Does not meet partial response or complete response	–	Increase in CD33 and CD3 chimerism but not 95% donor chimerism	> 95% donor chimerism in CD33 and CD3	–	–
Treatment of Disease Relapse / Progression	Refer to the disease specific manuals for disease criteria	Refer to the disease specific manuals for disease criteria	Refer to the disease specific manuals for disease criteria	Refer to the disease specific manuals for disease criteria	–	-
Treatment of MRD	Does not meet partial response or complete response	–	Refer to disease specific manuals for disease criteria	Refer to disease specific manuals for disease criteria	–	–
Other Indication	Best response not answered	Best response not answered	Best response not answered	Best response not answered	Best response not answered	Best response not answered

Question 39: Date response established

Report the date when the best response to the DCI was established. For DLIs, report the date when the best response was achieved within 30 – 60 days post-infusion. This should be the earliest date when all criteria were met.

For the following indications, report the date the sample was collected for evaluation (i.e., bone marrow biopsy, blood sample, etc.) or the date when imaging took place, if applicable. If no pathologic, radiographic, or laboratory assessments were performed to establish the best response, report the office visit in which the physician clinically evaluated the response.

• Immune reconstitution
• Infection treatment
• Insufficient hematopoietic recovery / graft failure
• Suboptimal donor chimerism
• Treatment of disease relapse / progression
• Treatment of MRD
  

For the following indication, report the office visit in which the physician clinically evaluated the response:

• GVHD treatment
  

If the exact date is unknown, review General Instructions, General Guidelines for Completing Forms for more information on reporting partial and unknown dates.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)

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