Q48-94: Disease Detection Since Date of Last Report

!Questions 48-94
This section is intended to capture information only on recipients who relapse, have persistent or minimal residual disease in this reporting period. For questions 48, 54, 61, 71, and 78, report “No” or “Unknown” (see instructions below) if the recipient did not relapse, have persistent or minimal residual disease even if testing was performed. These results will be reported in questions 95-120.

Questions 48-94 are intended to capture the earliest instance of disease detection by each method of assessment performed during the reporting period. For each method of assessment, report “Yes” if that method detected the recipient’s ALL (or markers of ALL) during the reporting period. If testing by a particular method (e.g., molecular makers, cytogenetic, flow cytometry, etc.) was done, but did not shown evidence of disease during the reporting period, report “No” for that method. If testing for molecular or cytogenetic markers / abnormalities was not done during the reporting period or it is not known whether testing was performed, report “Unknown” for those methods (question 48 and 61). If testing by flow cytometry, clinical / hematologic assessment, or other assessment was not done during the reporting period or it is not known whether testing was performed, report “No” for those methods (questions 54, 71, and 78).

If multiple tests by a particular method have demonstrated evidence of disease during the reporting period, report the date / result of the earliest positive assessment(s) performed during the reporting period.

Question 48-49: Were tests for molecular markers performed (e.g. PCR, NGS)?

See question 4 for a description of molecular testing. If any testing for molecular markers detected the recipient’s primary disease during the reporting period, report “Yes” for question 48 and report the date the sample was collected in question 49. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, Guidelines for Completing Forms.

If molecular marker testing did not detect disease at any time during the reporting period, report “No” for question 48 and go to question 54.

If molecular marker testing was not performed during the reporting period, report “Unknown” go to question 53. If it is not known whether testing for molecular markers was performed during the reporting period, or the test results are not known, report “Unknown” and go to question 53.

Question 50-53: Specify results

For each molecular marker in questions 50-53, report whether testing was “Positive,” “Negative,” or “Not done.” If tests identified a molecular marker other than those listed in questions 50-51, report the result in question 52 and specify the marker in question 53. If multiple “Other molecular markers” were tested at the time of best response, report one instance (i.e., copy) of question 52-53 for each “Other molecular marker” tested. If greater than 3 “Other molecular marker[s]” are tested, do the following:

• report one instance of question 52-53; and
• report “Positive” if any of the “Other molecular marker[s]” were positive, otherwise, report “Negative;” and
• report “see attachment” in question 53; and
• attach any / all reports documenting the results of testing for “Other molecular marker[s].”
  

Question 54: Was the disease detected via flow cytometry?

See question 9 for a description of flow cytometry. If flow cytometry detected the recipient’s primary disease at any time during the reporting period, report “Yes” and go to question 55. Report “No” and go to question 61 in either of the following cases:

• all flow cytometry assessments performed on the blood and marrow were negative for evidence of the recipient’s primary disease during the current reporting period; or
• flow cytometry testing was not performed on the blood or bone marrow during the reporting period.
  

Question 55-57: Flow cytometry testing on blood

Indicate whether flow cytometry detected disease in a blood sample at any time during the reporting period. If “Yes,” report the date the sample was collected and the percent disease detected (i.e., percent leukemic blasts) in questions 56 and 57 respectively. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, Guidelines for Completing Forms. Report “No” for question 55 and go to question 58 in either of the following cases:

• all flow cytometry assessments performed on the blood were negative for evidence of the recipient’s primary disease during the current reporting period; or
• flow cytometry testing was not performed on the blood during the reporting period.
  

If multiple flow cytometry assessments performed on blood samples were positive for disease, report the date / results of the earliest positive assessment performed during the reporting period.

Question 58-60: Flow cytometry testing on bone marrow

Indicate whether flow cytometry detected disease in a bone marrow sample at any time during the reporting period. If “Yes,” report the date the sample was collected and the percent disease detected (i.e., percent leukemic blasts) in questions 59 and 60 respectively. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, Guidelines for Completing Forms. Report “No” for question 58 and go to question 61 in either of the following cases:

• all flow cytometry assessments performed on the marrow were negative for evidence of the recipient’s primary disease during the current reporting period; or
• flow cytometry testing was not performed on the marrow during the reporting period.
  

If multiple flow cytometry assessments performed on bone marrow samples were positive for disease, report the date and results of the earliest positive assessment performed during the reporting period.

Question 61: Was disease detected by cytogenetic testing (karyotyping or FISH)?

Refer to question 18 for a description of cytogenetic studies. If cytogenetic testing detected the recipient’s primary disease at any time during the reporting period, report “Yes” and go to question 62. If all cytogenetic testing was negative for evidence of the recipient’s primary disease during the current reporting period, report “No” and go to question 71. Report “Unknown” for question 61 and go to question 71 in any of the following cases:

• cytogenetic testing was not performed during the reporting period; or
• cytogenetic testing was attempted, but no assessments could be performed during the reporting period (e.g., insufficient sample); or
• it cannot be determined whether cytogenetic testing was performed during the reporting period.
  

Question 62-63: Were cytogenetic abnormalities identified via FISH?

Indicate whether FISH studies detected disease at any time during the reporting period. If “Yes,” report the date the sample was collected in question 63 and go to question 64. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, Guidelines for Completing Forms. Report “No” for question 62 and go to question 66 in any of the following cases:

• FISH testing was not performed during the reporting period; or
• FISH testing was attempted, but no assessments could be performed during the reporting period (e.g., insufficient sample); or
• it cannot be determined whether FISH testing was performed during the reporting period.
  

If multiple FISH assessments were positive for disease, report the date / results of the earliest positive assessment performed during the reporting period.

Question 64-65: Specify cytogenetic abnormalities (FISH)

Select all clonal cytogenetic abnormalities detected by FISH on the date reported in question 63. If an abnormality is detected, but not listed as an option in question 64, select “Other abnormality” and specify the abnormality in question 65. If multiple “Other abnormalities” were detected by FISH at the time of best response, report “see attachment” in question 65 and attach a copy of the FISH report. For further instructions on how to attach documents in FormsNet3^SM, refer to the Training Guide.

Question 66-67: Were cytogenetic abnormalities identified via karyotyping?

Indicate whether karyotyping studies detected disease at any time during the reporting period. If “Yes,” report the date the sample was collected in question 67 and go to question 68. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, Guidelines for Completing Forms. Report “No” for question 66 and go to question 70 in any of the following cases:

• karyotyping was not performed during the reporting period; or
• karyotyping was attempted, but no assessments could be performed during the reporting period (e.g., insufficient sample); or
• it cannot be determined whether karyotyping was performed during the reporting period.
  

If multiple karotypes were positive for disease, report the date / results of the earliest positive assessment performed during the reporting period.

Question 68-69: Specify cytogenetic abnormalities (karyotyping)

Select all clonal cytogenetic abnormalities detected by karyotyping on the date reported in question 68. If an abnormality is detected, but not listed as an option in question 68, select “Other abnormality” and specify the abnormality in question 69. If multiple “Other abnormalities” were detected by karyotyping at the time of best response, report “see attachment” in question 69 and attach a copy of the karyotype report. For further instructions on how to attach documents in FormsNet3^SM, refer to the Training Guide.

Question 70: Was documentation submitted to the CIBMTR?

Indicate if a karyotyping or FISH testing report is attached to support the reported cytogenetic findings in question 61-69. For further instructions on how to attach documents in FormsNet3^SM, refer to the Training Guide.

Question 71-72: Was disease detected by clinical / hematologic assessment?

Clinical / hematologic assessments include, but are not limited to, biopsies, imaging assessments, complete blood counts, and physical exams. If clinical / hematologic testing detected disease during the reporting period, report “Yes” for question 71 and report the date of the positive assessment in question 72. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, Guidelines for Completing Forms.

If multiple clinical / hematologic assessments detected disease, report the date of the earliest positive assessment performed during the reporting period.

Question 73-77: Specify Sites of Disease

Report “Yes” for each site where disease was detected by clinical / hematologic methods on the date reported in question 72. If clinical / hematologic assessments detected disease at a site not specified in questions 73-75, report “Yes” for question 76 and specify all other sites where disease was detected on the date reported in question 77.

Report “No” if a site:

• was not tested during the reporting period; or
• was tested during the reporting period, but disease was not detected.
  

Question 78-80: Was disease detected by other assessment?

Indicate whether the recipient’s primary disease was assessed by any method other than those included in questions 48-77 during the reporting period. If “Yes,” report the date assessed and specify the type of assessment in questions 79 and 80 respectively. If the exact date of assessment is not known, use the process for reporting partial or unknown dates as described in the General Instructions, Guidelines for Completing Forms. If ALL was not assessed by any methods other than those included in questions 48-77, report “No” for question 88 and go to question 81.

Question 81: Was intervention given for relapsed disease or progressive disease, or minimal residual disease? (since the date of last report)

Indicate if the recipient received treatment post-infusion for minimal residual disease, persistent disease, or relapse since the date of last report. If “Yes,” go to question 82. If “No,” go to question 95. See question 82 for definitions each of these indications for treatment.

Question 82: Specify reason for which intervention was given

Select the indication for which treatment was administered during the reporting period. See below for definitions of each indication.

Minimal Residual Disease: Recipient is in hematologic CR, but has evidence of disease by more sensitive assessments including molecular, flow cytometry or cytogenetic methods.

Persistent Disease: The recipient was in primary induction failure or relapse at the time of infusion and has not achieved a hematologic CR post-infusion.

Relapsed Disease: The recipient was in CR at the time of infusion or the recipient achieved a CR post-infusion. In either case, treatment is administered for a relapse which occurred post-infusion.

Question 83: Central nervous system irradiation

See question 36 for a description of central nervous system (CNS) irradiation. If the recipient received CNS irradiation to treat minimal residual disease, persistent disease, or relapse during the reporting period, report “Yes.” If not, report “No.”

Question 84: Intrathecal Therapy

See question 39 for a description of intrathecal therapy. If intrathecal therapy was given as part of treatment for minimal residual disease, persistent disease, or relapse, report “Yes.” If not, report “No.”

Question 85: Systemic therapy

See question 40 for a description of systemic therapy. Do not report total body irradiation or subsequent HCT / cellular therapies in questions 85-89. If the recipient received systemic therapy during the reporting period for minimal residual disease, persistent disease, or relapse, report “Yes” and go to question 86. If not, report “No” and go to question 90.

Question 86-87: Date therapy was first started post-HCT / post-infusion

*Form Revision Change
If maintenance therapy was started during a prior reporting period, for which, an ALL Post-HCT Data Form Revision 3 was completed, the start date will not have been reported on that form. In this case, report the date maintenance therapy was started on the current form (ALL Post-Infusion Data Form, Revision 4) and override the validation error using the code “Verified Correct.” If the reported maintenance therapy continues into the next reporting period, the site will indicate “Previously reported” in question 86.

If the recipient started systemic therapy for minimal residual disease, persistent disease, or relapse during the reporting period, report “Known” for question 86 and indicate the date started in question 87. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, Guidelines for Completing Forms.

If the recipient started therapy for minimal residual disease, persistent disease, or relapse in a prior reporting period and continued the therapy into the current reporting period, report “Previously reported” and go to question 88.

For recipients who start and stop therapy multiple times post-infusion, first determine whether the recipient stopped therapy for at least 30 days. If not, consider the therapy continuous. Only report a new therapy start date if all three of the below conditions are met

1. The recipient stopped all therapy given for minimal residual disease, persistent disease, or relapse during a prior reporting period; and
2. The recipient restarted therapy for minimal residual disease, persistent disease, or relapse during the current reporting period; and
3. Therapy was restarted at least 30 days after the therapy stop date.

Question 88-89: Specify systemic therapy given

Select all systemic therapy (see question 40 for definition) given for minimal residual disease, persistent disease, or relapse during the reporting period. If a therapy is given, but not listed as an option in question 88, select “Other systemic therapy” and specify the drug in question 89.

Question 90: Cellular therapy

Cellular therapy treatment strategies include isolation and transfer of specific stem cell populations, administration of effector cells (e.g., cytotoxic T-cells), induction of mature cells to become pluripotent cells, and reprogramming of mature cells (e.g., CAR T-cells).

Report “Yes” if the recipient received cellular therapy as treatment for minimal residual disease, persistent disease, or relapse during the reporting period. If not, report “No.”

Question 91: Subsequent HCT

Indicate whether the recipient received a HCT since the date of the last report (or since infusion if completing this is the 100 day follow-up form). Hematopoietic stem cells (HSC) are defined as mobilized peripheral blood stem cells, bone marrow, or cord blood. The source of HSC may be allogeneic unrelated, allogeneic related, or autologous. For more information on how to distinguish infusion types (example: HCT versus DCI), see Appendix D.

Question 92: Accelerated withdrawal of immunosuppression

Immunosuppressive medications may be tapered or entirely withdrawn in order to promote a graft vs leukemia effect in the setting of relapsed, progressive, or persistent disease. For reporting purposes, accelerated withdrawal is defined as any decrease in immunosuppression to promote graft versus leukemia effect.

If the recipient undergoes an accelerated withdrawal immunosuppression during the reporting period in order to treat disease, report “yes.” If not, report “no.”

Question 93-94: Other therapy

Indicate if the recipient received any other treatment for minimal residual disease, persistent disease, or relapse during the reporting period. If “Yes,” specify the type of treatment administered in question 94. If “No,” go to question 95.

Section Updates:

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