Q77 – 84: Post-Infusion Intervention for Disease

!Malignant Diseases Only
Only complete the post-infusion intervention for disease questions if the infusion being reported was given to treat a malignant disease. If the infusion being reported was given to treat a non-malignant disease, leave these questions blank. Intervention for relapsed, persistent, or progressive disease questions must be completed regardless of disease type. FormsNet3SM should enable / disable this section based on the primary disease reported on the Disease Classification (2402) Form. Contact CIBMTR Center Support if it is believed FormsNet3^SM is incorrectly enabling / disabling these fields.

*Combined Follow-Up
In scenarios where a cell therapy was given after an HCT and this form is now being completed based on the subsequent cell therapy date, these questions do not apply and are disabled. This information will be captured on the corresponding disease-specific form, if applicable.

Question 77: Was intervention given for decreased / loss of chimerism, measurable residual disease, persistent disease, or progressive / relapsed disease? (Do NOT include any maintenance therapy)

Indicate whether therapy was given during the reporting period for decrease / loss of chimerism, persistent disease, progressive / relapsed disease, measurable residua disease, or consolidation therapy. Do not include therapy given for maintenance. Any post-infusion therapy included as part of the initial transplant protocol is reported in a subsequent section below.

Relapse / progression treatment given in the same reporting period where the first relapse / progression occurred is only reported. If treatment for relapse / progression started after the reporting period in which relapse / progression was first reported in, this section is disabled.

See the Intervention Reporting Scenarios provided below for further clarification.

Question 78: Specify reason for which intervention was given (check all that apply)

Report the reason why therapy for decreased / loss of chimerism, measurable residual disease, persistent disease, progressive disease, or relapsed disease was given in the reporting period. Select all the indications. See below for definitions of each indication. If the intent of the therapy is unclear, seek physician clarification.

• Decreased / loss of chimerism: Chimerism is the percentage of donor immune cells in a recipient compared to the percentage of recipient immune system cells. Treatment may be given for decreasing chimerism to prevent relapsed disease.
• Measurable residual disease: Recipient is in clinical / hematologic CR but has evidence of disease by more sensitive assessments including molecular, flow cytometry or cytogenetic methods. Select this option if consolidation treatment was given for MRD. Do not select this option if maintenance treatment was given for MRD. If the intent of therapy is unclear, seek physician clarification.
• 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.
• Progressive disease: The recipient has not achieved a complete remission and has worsening disease burden. This option is only applicable if the method of detection for which intervention was given was for ‘radiological’ or ‘clinical / hematologic’ methods.
• 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. This option is applicable if the method of detection for which intervention was given was for ‘molecular,’ ‘flow cytometry,’ ‘cytogenetic’ ‘radiological’ or ‘clinical / hematologic’ methods.

See the Intervention Reporting Scenarios provided below for further clarification.

Question 79: Specify the method(s) of detection for which intervention was given (check all that apply)

Indicate the methods detecting the reason for which therapy for decreased / loss of chimerism, consolidation, measurable residual disease, persistent disease, progressive disease, or relapsed disease was administered (as reported above). Indicate all methods of detection; given that the assessment was performed prior to the start of the intervention(s) and was consistent with the rationale reported above. There may be scenarios for which an assessment by a particular method was last performed in the prior reporting period but was still consistent with the justification reported; in this case, that method of disease assessment should be reported.

If multiple therapies were given during the reporting period for different reasons (i.e., the recipient initially receives treatment for persistent disease and subsequently receives different treatment for progressive disease during the same reporting period), select all methods of detection confirming the reasons above. See the Intervention reporting scenarios provided below for further clarification.

If assessment by that method was not performed or was performed and not consistent with the reason for which intervention was given reported above, do not report the disease assessment.

Question 80: Date intervention started

Report the date therapy was started for the reason specified above; if multiple instances, cycles, or lines of therapy are administered, report the date of the first treatment. If treatment was started in a prior reporting period and continues into the current reporting period, report the original therapy start date (prior to the start of the current reporting period) and override the validation error in FormsNet3^SM using the code ‘verified correct.’ If therapy was stopped in a prior reporting period and restarted (or a new therapy was started) during the current reporting period, report the earliest date treatment was administered during the current reporting period. See the Intervention Reporting Scenarios provided below for further clarification.

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

Intervention Reporting Scenarios

• Example 1: A recipient with NHL in CR at the time of infusion has a relapse during the Day 100 reporting period. Relapse was detected by a PET scan and a lymph node biopsy. Following these assessments, Rituximab was started on 5/1/2016. The disease did not respond to this therapy prompting a switch to Brentuximab on 6/1/2016. The 100 Day date of contact is 6/15/2016.
  • Day 100
    • Was intervention given for decreased / loss of chimerism, measurable residual disease, persistent disease, or progressive / relapsed disease: Report Yes to indicate therapy was given for relapsed disease during this reporting period.
    • Specify reason for which intervention was given: Report Relapsed disease.
    • Specify the method(s) of detection for which intervention was given: Check the boxes to indicate that disease was detected by both Clinical / hematologic (lymph node biopsy) and Radiological (PET scan) assessments.
    • Date intervention started: Report 5/1/2016 to reflect the date of the first treatment given for relapsed disease.
    • Specify systemic therapy: Report both Rituximab and Brentuximab as treatments for relapsed disease given during the reporting period.
• Example 2: A recipient with multiple myeloma in VGPR at the time of infusion was started on maintenance Lenalidomide during the six-month reporting period. Later in the reporting period, progression was detected by serum protein electrophoresis on 9/15/2014 and so the recipient stopped lenalidomide and started bortezomib and dexamethasone on 9/20/2014. Thirty days after starting bortezomib and dexamethasone, karyotyping confirmed persistent cytogenetic abnormalities present (completed in the six-month reporting period). The recipient continued bortezomib and dexamethasone treatment into the one-year reporting period, during which, the disease further progressed. Bortezomib and dexamethasone were stopped, and carfilzomib was started on 1/1/2015.
  • Six Month
    • Was intervention given for decreased / loss of chimerism, measurable residual disease, persistent disease, or progressive / relapsed disease: Report Yes to indicate therapy was given for progressive disease during this reporting period.
    • Specify reason for which intervention was given: Report Progressive disease.
    • Specify the method(s) of detection for which intervention was given: Check the box to indicate that disease was detected by Clinical / hematologic (serum protein electrophoresis) assessment.
      • Karyotype is not reported as a method of detection since this was completed after starting treatment and therefore, did not inform the decision to start bortezomib and dexamethasone.
    • Date intervention started: Report 9/20/2014 to reflect the date of the first treatment given for progressive disease.
    • Specify systemic therapy: Report Bortezomib as treatment for progressive disease given during the reporting period. Dexamethasone is no longer captured on the Post-TED (2450) Form.
      • Lenalidomide should not be reported in this section of the form. This medication was given as maintenance therapy and will therefore be reported under Post-Infusion Treatment Given to Prevent Relapse or Progression.
  • One Year
    • Was intervention given for decreased / loss of chimerism, measurable residual disease, persistent disease, or progressive / relapsed disease: These questions will be disabled in FormsNet3^SM. Starting with Revision 5 of the Post-TED (2450) Form, therapy given for relapsed or progressive disease will only be captured in the reporting period in which treatment first started.
• Example 3: A recipient with ALL was in CR at the time of infusion; however, was BCR-ABL positive by ClonoSEQ® and molecular methods. During the Day 100 reporting period, imatinib was started on 12/20/2018 as maintenance therapy to prevent relapse as measurable residual disease was still detected (BCR-ABL remained positive by ClonoSEQ® and molecular assessments). At the end of the Day 100 reporting period, ClonoSEQ® was reassessed which detected worsening BCR-ABL and as a result, imatinib was stopped and dasatinib was started on 2/1/2019 and continued into the six-month reporting period. At the end of the six-month reporting period, the recipient relapsed in the bone marrow and was reinduced with hyper-CVAD on 7/30/2019.
  • Day 100
    • Was intervention given for decreased / loss of chimerism, measurable residual disease, persistent disease, or progressive / relapsed disease: Report Yes to indicate therapy was given for measurable residual disease during this reporting period.
    • Specify reason for which intervention was given: Report* Measurable residual disease*.
    • Specify the method(s) of detection for which intervention was given: Check the box to indicate that disease was detected by Molecular (ClonoSEQ®) assessment.
    • Date intervention started: Report 2/1/2019 to reflect the date of the first treatment started for worsening MRD.
      • Therapy started on 12/20/2018 is not reported as the start date as that therapy was given for maintenance.
    • Specify systemic therapy: Report Dasatinib as the only treatment given during the reporting period.
      • Imatinib is not reported as that was given as maintenance.
  • Six Month
    • Was intervention given for decreased / loss of chimerism, measurable residual disease, persistent disease, or progressive / relapsed disease: Report Yes to indicate therapy was given for measurable residual disease and relapse disease during this reporting period.
    • Specify reason for which intervention was given: Report Measurable residual disease and Relapsed disease.
      • If therapy continued from a prior reporting period and a new therapy was started for a different reason during the current reporting period, report all reasons why the therapy was given in the current reporting period.
    • Specify the method(s) of detection for which intervention was given: Check the box to indicate that disease was detected by Molecular (ClonoSEQ®) and Clinical / hematologic (bone marrow) assessment.
    • Date intervention started: Report 2/1/2019 to reflect the date of the first treatment started for worsening MRD and override the FormsNet3^SM error as ‘verified correct.’
      • When therapy is continued from a previous reporting period and therapy changes, the start date of the first drug given in the reporting period (i.e., drug started in a prior reporting period) is reported and the FormsNet3^SM error is overridden.
    • Specify systemic therapy: Report the Dasatinib and Chemotherapy as treatments received during the reporting period

Question 81: Specify intervention (check all that apply)

Indicate which therapies were given in the current reporting period for decreased / loss of chimerism, measurable residual disease, persistent disease, or progressive / relapsed disease.

• Accelerated withdrawal of immunosuppression in response to disease assessment: 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.
• Blinded randomized trial: A blinded, randomized trial refers to a research treatment protocol in which the participant is assigned to the control arm or investigational group, and the researcher or clinician is not informed whether the subject is receiving the placebo or standard of care versus the investigational therapy. This makes it impossible to report agents or therapies the recipient is receiving.
• Intrathecal therapy: Intrathecal therapy is chemotherapy administered to the CNS via a lumbar puncture. It may be given to treat or prevent leukemic blasts in the cerebrospinal fluid or other CNS tissues.
• Radiation: Radiation therapy uses high-energy radiation to kill cancer cells. External beam radiation is one of the more frequently used types of radiation. In this method, a beam of radiation is delivered to a specific part of the body, such as the mediastinum. Radiation may be planned if bulky disease was present just prior to transplant for a recipient with lymphoma or a solid tumor.
• Systemic therapy: refers to a delivery mechanism where a therapeutic agent is delivered orally or intravenously, enters the bloodstream, and is distributed throughout the body.
• Other intervention: Indicate whether the recipient received additional therapy for decreased / loss of chimerism, measurable residual disease, persistent disease, progressive / relapsed disease which does not fit into the previous categories (i.e. surgery). Specify the other intervention given. Do not report a subsequent infusion (i.e. DLI, cellular therapy, subsequent HCT) in this field if one was given. All subsequent infusions will be captured at the top of this form and do not need to be re-reported.

!Steroids Administered Post-Infusion
Previously, steroids given for relapsed, persistent, or progressive disease were reported as Other systemic therapy. Steroids (e.g. dexamethasone) are no longer captured on the Post-TED (2450) Form and they should not be reported.

Questions 82 – 84: Specify systemic therapy (check all that apply)

Systemic therapy agents and treatment regimens vary based on disease, prognosis, and protocol. Treatment may consistent of one or multiple drugs and may be given in an inpatient or outpatient setting; additionally, drugs may be administered on a single day, over consecutive days, or continuously.

Indicate which systemic therapy agents were administered during the current reporting period for decreased / loss of chimerism, consolidation, measurable residual disease, persistent disease, progressive disease, or relapsed disease. If the recipient received a chemotherapy agent that is not listed (i.e., cyclophosphamide), Chemotherapy should be selected. If the recipient received a therapeutic agent, other than chemotherapy, that is not listed, select Other systemic therapy and specify the systemic therapy.

Section Updates:

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