Question 34: Were tests performed to detect persistence of the cellular product since the date of last report?

Methods such as PCR assays, flow cytometry (immunophenotyping) or immunohistochemistry can be used to detect persistence of the cellular product in the recipient.

If tests were performed to detect persistence of the cellular product since the date of the last report, select “yes” and continue with question 35.

If tests were not performed to detect persistence of the cellular product since the date of the last report, select “no” and continue with question 57.

Question 35: Was persistence evaluated by molecular assay (PCR)?

Molecular assessment involves testing blood, bone marrow, tumor or other source for the presence of known molecular markers. Molecular assessments are the most sensitive test and involve amplifying regions of cellular DNA by polymerase chain reaction (PCR), typically using RNA to generate complementary DNA through reverse transcription (RT-PCR). The amplified DNA fragments are compared to a control, providing a method of quantifying log increase of genetic mutation transcripts. Each log increase is a 10-fold increase of gene transcript compared to control.

Indicate whether molecular assay testing was performed to detect the persistence of the genetically- modified cellular product within the reporting period. If “yes”, continue with question 36. If “no”, continue with question 40.

Question 36: Date Sample collected:

Report the date (YYYY-MM-DD) the sample was collected for molecular assay. If multiple tests were performed in the reporting period and

  • all tests were negative: report the first negative test result
  • there were positive and negative results: report the date of the last positive test.

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

Question 37-38: Specify the cell source:

Select bone marrow, peripheral blood, tumor, or other source as the cell source of the sample collected for evaluation by molecular assay. If the source is “other”, specify in question 38.

Question 39: Were the infused cells detected?

Select “yes” if the infused cells were detected by molecular assay. Select no” if the infused cells were not detected by molecular assay.

Question 40: Was persistence evaluated by flow cytometry testing (immunophenotyping)?

Flow cytometry is a technique that can be performed on blood, bone marrow, or tissue preparations where cell surface markers can be quantified on cellular material. The nature of flow cytometry is to detect cells based on a specific probe. To report flow cytometry results, the test must have been performed to specifically detect the genetically-modified cellular product.

Indicate whether flow cytometry testing was performed to detect the persistence of the genetically-modified cellular product within the reporting period. If “yes”, continue with question 41. If “no”, continue with question 45.

Question 41: Date sample collected:

Report the date (YYYY-MM-DD) the sample was collected for flow cytometry testing (immunophenotyping). If multiple tests were performed in the reporting period and

  • all tests were negative: report the first negative test result
  • there were positive and negative results: report the date of the last positive test

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

Question 42-43: Specify the cell source:

Select bone marrow, peripheral blood, tumor, or other source as the cell source of the sample collected for evaluation by flow cytometry. If other, specify in question 43.

Question 44: Were the infused cells detected?

Select “yes” if the infused cells were detected by flow cytometry testing (immunophenotyping). Select “no” if the infused cells were not detected by flow cytometry testing (immunophenotyping).

Question 45: Was B-cell aplasia identified?

CAR-T cells that target antigens on B cells do not distinguish between cancerous and normal B cells. As a result, the recipient can develop B-cell aplasia (low number or absence of B cells). B cell aplasia can be used as a surrogate to track persistence of the product. If the recipient has B cell aplasia, then the product is still present.

Question 46: Was persistence evaluated by immunohistochemistry?

Immunohistochemistry is a process that uses antibodies to test for certain antigens (markers) in a sample. When the antibodies bind to the antigen in the tissue sample, the enzyme or dye is activated, and the antigen can then be seen under a microscope.

Indicate whether immunohistochemistry testing was performed to detect the persistence of the genetically- modified cellular product within the reporting period. If “yes”, continue with question 47. If “no”, continue with question 51.

Question 47: Date sample collected:

Report the date (YYYY-MM-DD) the sample was collected for immunohistochemistry studies. If multiple tests were performed in the reporting period and

  • all tests were negative: report the first negative test result
  • there were positive and negative results: report the date of the last positive test

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

Question 48-49: Specify the cell source:

Select bone marrow, peripheral blood, tumor, or other source as the cell source of the sample collected for evaluation by immunohistochemistry testing. If other, specify in question 49.

Question 50: Were the infused cells detected?

Select “yes” if the infused cells were detected by immunohistochemistry testing. Select “no” if the infused cells were not detected by immunohistochemistry testing.

Questions 51-52: Was persistence evaluated by other method?

If persistence of cells was tested by a method not listed above, select “yes” and continue with question 52. If “no”, continue with question 57.

Specify the other method used to evaluate persistence of cells in question 52.

Question 53: Date sample collected:

Report the date (YYYY-MM-DD) the sample was collected for the other method. If multiple tests were performed in the reporting period and

  • all tests were negative: report the first negative test result
  • there were positive and negative results: report the date of the last positive test

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

Question 54-55: Specify the cell source:

Select bone marrow, peripheral blood, tumor, or other source as the cell source of the sample collected for evaluation by other method. If other, specify in question 55.

Question 56: Were the infused cells detected?

Select “yes” if the infused cells were detected by other method. Select “no” if the infused cells were not detected by other method.

Last modified: Jan 27, 2020

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