This section collects the data known as “best response to transplant.” The purpose of this section is to report the recipient’s best response to the planned course of the HCT. This includes response to any therapy given for post-HCT maintenance or consolidation, and does not include response to treatment given for relapsed, progressive or persistent disease. Best response is often achieved in the first 100 days. However, for some diseases such as multiple myeloma and CLL, the best response to HCT may take longer.

If the recipient relapses / progresses post-HCT and receives therapy for the disease relapse/progression, the response to that additional therapy should not be reported in this section. The best response prior to the relapse / progression should be reported. Reporting periods subsequent to that in which best response prior to the start of unplanned was reported will indicate that best response was previously reported.

Tandem Transplants: For recipients receiving a tandem transplant, the best response to the prior transplant (i.e., HCT #1 of the tandem) depends on the pre-transplant disease status.

  • If the recipient was in complete remission at the time of HCT #1 or achieved complete remission prior to HCT #2 of their tandem transplant, report the best response to transplant as “Continued complete remission (CCR)”.
  • If the recipient was not in complete remission or did not achieve complete remission in response to HCT #1 prior to HCT #2 of their tandem transplant, either “Not in complete remission (NCR)” or “Not evaluated” would be appropriate options, however, ensure the best response to transplant and the current diseases status are answered consistently.

Question 80: Compared to the disease status prior to the preparative regimen, what was the best response to HCT since the date of the last report? (Include response to any therapy given for post-HCT maintenance or consolidation, but exclude any therapy given for relapsed, persistent, or progressive disease):

If the recipient was already in CR at the start of the preparative regimen, check “Continued complete remission (CCR)” and continue with question 103.

If the recipient achieved CR post-HCT (excluding unplanned therapy), check “complete remission (CR)” and continue with question 82.

If the recipient has not achieved a post-HCT CR to date, check “not in complete remission” and continue with question 81.

If the recipient’s disease status was not evaluated post-HCT, check “not evaluated” and continue with question 103. This option is not commonly used, as this would indicate that no tests (radiological, laboratory, or a clinical assessment) were performed to assess the CR status at any time during the reporting period.

If the recipient never achieved a post-transplant complete response and started unplanned therapy, given for relapsed, persistent, or progressive disease, in a previous reporting period, indicate “not evaluated.”

Example 1: A recipient with neuroblastoma is not in complete remission prior to transplant, in the 100-day reporting period the recipient receives a tandem transplant. Between HCT 1 and HCT 2 the only disease assessment performed was a clinical evaluation. In this case either option would be appropriate to answer for question 80: “Not evaluated” or “Not in complete remission (NCR)” and “no disease detected but incomplete evaluation to establish CR” for question 81.

Question 81: Specify disease status if not in complete remission:

For recipients “not in complete remission,” indicate whether clinical evidence of disease persisted on disease-specific assessments within the reporting period. If all assessments have shown resolution of disease, but not all assessments required to report complete remission have been completed, indicate “no disease detected but incomplete evaluation to establish CR.” This option is also appropriate for scenarios in which the recipient has not previously achieved a post-HCT CR but does not have any disease assessments performed within the reporting period. Indicate “disease detected” if disease persists by any method of radiological or clinical assessment; persistence of abnormalities by molecular, cytogenetic, or flow cytometry assessments does not constitute “disease detected.”

Example 1: A recipient with multiple myeloma goes to transplant in VGPR, without a bone marrow showing < 5% plasma cells completed prior to transplant. Post-transplant serum and urine electrophoreses and immunofixations are negative. However, no bone marrow biopsy is performed within the 100-day reporting period. In this case, “not in complete remission” should be selected for question 80, and “no disease detected by incomplete evaluation to establish CR” for question 81.

Example 2: A recipient with AML goes to transplant in primary induction failure. Post-transplant, they recover their counts, but had circulating blasts noted on differential. They expire due to persistent disease with their last CBC performed on their date of death showing circulating blasts. In this case, “not in complete remission” should be selected for question 80, and “disease detected” for question 81.

Example 3: Similar to example 2, a recipient with AML goes to transplant in primary induction failure. They expire on D+11 due to infection, and had not engrafted as of that date. Their last CBC showed a WBC of 0.5 × 109/L with no blasts detected on their differential. A bone marrow biopsy was not performed between transplant and the date of death. In this case, “not in complete remission” should be selected for question 80, and “no disease detected by incomplete evaluation to establish CR” in question 81.

Question 82: Was the date of best response previously reported?

Indicate whether complete remission was reported in a previously reporting period; if “yes,” continue with question 103 and if “no,” continue with question 83. This question does not apply for “not in complete remission” responses to question 80.

Question 83: Date assessed:

Report the date complete remission was achieved. This date should fall after transplant but before or on the date of contact for the current reporting period. This should reflect the date of specimen collection or imaging for the latest assessment required to fulfill complete remission criteria for the recipient’s transplant disease.

Disease Assessment at Time of Best Response

Questions 84-102 refer to disease assessments performed at the time of best response (question 81). The following guidelines should be used to determine whether testing was performed at the time of best response:

If the recipient’s best response is “Not in Complete Remission,” report the latest assessment performed during the reporting period. If the recipient never achieved a CR and started treatment for progressive disease (excluding treatment for minimal residual disease), report the most recent assessments prior to progression. Review example E below.

If the recipient’ best response is “Complete Remission,” report testing performed closest to the date of best response (questions 83) and within the time windows in the Disease Assessment Time Windows table.

Disease Assessment Time Windows

Follow-Up Form Approximate Range
100 Day +/- 15 days of date of best response (question 78)
6 Month +/- 15 days of date of best response (question 78)
Annual +/- 30 days of date of best response (question 78)

Disease Assessment Reporting Scenarios:

A. A recipient receives a transplant on 1/1/2015 for multiple myeloma in partial remission. Prior to HCT, FISH testing detects an IGH rearrangement associated with the recipient’s primary disease. During the 100 day reporting period, the recipient achieves a very good partial remission. FISH testing is only performed on 2/1/2015 is positive for the previously detected IGH rearrangement. The 100 day date of contact is 4/15/2015. In this case, the center would report the recipient was “Not in Complete Remission” on the 100 Day Post-TED Form. The center would report FISH testing was performed on 2/1/2015. When the best response is “Not in Complete Remission” report the most recent testing performed during the reporting period (assuming treatment was not started for relapsed, progressive, or persistent disease during the reporting period – see Scenario B).

B. A recipient receives a transplant on 1/1/2015 for multiple myeloma in partial remission. Prior to HCT, FISH testing detects an IGH rearrangement associated with the recipient’s primary disease. During the 100 day reporting period, the recipient has disease progression and starts treatment on 3/1/2015. FISH testing is performed on 2/1/2105 and 3/15/2015. Both tests are positive for the previously detected IGH rearrangement. The 100 day date of contact is 4/15/2015. In this case, the center would report the recipient was “Not in Complete Remission” on the 100 Day Post-TED Form. The center would report FISH testing was performed on 2/1/2015. When the best response is “Not in Complete Remission” report the most recent testing performed during the reporting period and prior to treatment for relapsed, progressive or persistent disease.

Note: For all subsequent reporting periods, the center would report “Not Evaluated” for question 80 and skip questions 81-102. If treatment was started in a prior reporting period, the center is not able to report and assessments performed during the reporting period and prior to treatment

C. A recipient receives a transplant on 1/1/2015 for AML in primary induction failure. Prior to HCT, molecular testing confirms the recipient’s disease is FLT3 positive. On 2/1/2015, the recipient achieves a hematologic remission, but FLT3 is not tested at that time. Later, on 2/10/2015, molecular testing is performed and confirms the recipient is FLT3 negative. In this case, the center would report the recipient achieved a CR on 2/1/2015 on the 100 Day Post-TED Form. The center would report molecular testing was performed at the time of best response as testing was done within 15 days of 2/1/2015.

D. A recipient receives a transplant on 1/1/2015 for AML in primary induction failure. Prior to HCT, molecular testing confirms the recipient’s disease is FLT3 positive. On 2/1/2015, the recipient achieves a hematologic remission, but FLT3 is not tested at that time. Later, on 3/1/2015, molecular testing is performed and confirms the recipient is FLT3 negative. In this case, the center would report the recipient achieved a CR on 2/1/2015 on the 100 Day Post-TED Form. The center would report no molecular testing was performed at the time of best response as testing was not done within 15 days of 2/1/2015.

E. A recipient receives a transplant on 1/1/2015 for NHL in stable disease. During the 100 Day reporting period, a PET / CT was performed on Day 60, confirming stable disease but then on Day 95, another PET / CT was performed and showed progression. As a result, therapy for progression began on Day 100. The best response to HCT for the Day 100 reporting period would be reported as “Not in complete remission – disease detected” and report “Yes,” radiologic assessments were performed with the Day 60 PET / CT as this is the most recent scan prior to progression.

Molecular

Question 84: Was the disease status assessed by molecular testing (e.g. PCR)?

Molecular assessment involves determining whether a molecular marker for the disease exists in the blood or bone marrow. Molecular assessment is the most sensitive method of detection and can indicate known genetic abnormalities associated with the disease for which the HCT was performed. Molecular assessments include polymerase chain reaction (PCR) amplification to detect single specific disease markers; however, molecular methods are evolving and now include Sanger sequencing and next generation sequencing (e.g., Illumina, Roche 454, Proton / PGM, SOLiD). Molecular marker results identified by FISH or chromosomal microarray assessments should not be reported as molecular testing.

Report “not applicable” if molecular studies were never performed or have never shown abnormalities associated with the recipient’s primary transplant disease.

Once an assessment is positive for disease, “not applicable” will never be an appropriate response.

Report “no” if molecular studies were not performed during the reporting period.

If the recipient’s best response is “Not in Complete Remission,” report the latest assessment performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease (excluding treatment for minimal residual disease). If testing was not performed prior to the initiation of treatment, report “no” and go to question 87.

If the recipient’ best response is “Complete Remission,” report testing performed closest to the date of best response (question 83) and within the time windows in the Disease Assessment Time Windows table. If testing was not performed within the applicable time window, report “no” and go to question 87.

Question 85: Date assessed:

If the best response is “complete remission,” report the date of testing performed nearest the date of best response and prior to relapse or progression, if applicable.

If the best response is “not in complete remission,” report the date of the most recent testing performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease, if applicable. If no treatment for relapsed, progressive, or persistent disease was given, report the date of the most disease-specific testing performed within approximately 30 days of the follow-up date.

Report the date of specimen collection for molecular disease assessment. If exact date is not known, refer to General Instructions, General Guidelines for Completing Forms for information about reporting partial or unknown dates.

Question 86: Was disease detected?

Report whether the recipient’s primary disease was detected by molecular testing on the date reported in question 83. In order to be considered positive for disease, the assay must detect a number of copies of the molecular marker exceeding the threshold for sensitivity of the assay, for a quantitative study. However, do note that presence of only a single marker among numerous tested is sufficient to indicate disease detected.

Flow Cytometry

Question 87: Was the disease status assessed via flow cytometry?

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. This allows for the detection of abnormal cell populations for some diseases.

Report “not applicable” if flow cytometry was never performed or have never shown abnormalities associated with the recipient’s primary transplant disease.

Once an assessment is positive for disease, “not applicable” will never be an appropriate response.

Report “no” if flow cytometry was not performed during the reporting period.

If the recipient’s best response is “Not in Complete Remission,” report the latest assessment performed during the reporting period and prior to any treatment for relapsed, progressive, or persistent disease (excluding treatment for minimal residual disease). If testing was not performed prior to the initiation of treatment, report “no” and go to question 90.

If the recipient’ best response is “Complete Remission,” report testing performed closest to the date of best response (question 81) and within the time windows in the Disease Assessment Time Windows table. If testing was not performed within the applicable time window, report “no” and go to question 90.

Question 88: Date assessed

If the best response is “complete remission,” report the date of testing performed nearest the date of best response and prior to relapse or progression, if applicable.

If the best response is “not in complete remission,” report the date of the most recent testing performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease, if applicable. If no treatment for relapsed, progressive, or persistent disease was given, report the date of the most disease-specific testing performed within approximately 30 days of the follow-up date.

Report the date of specimen collection for flow cytometry assessment. If exact date is not known, refer to General Instructions, General Guidelines for Completing Forms, for information about reporting partial or unknown dates.

Question 89: Was disease detected?

Report whether the recipient’s primary disease was detected by flow cytometry on the date reported in question 88. Report “disease detected” if an abnormal cell population associated with the recipient’s primary transplant disease was detected regardless of the sensitivity of the flow cytometry panel performed; this means an abnormal cell population detected by MRD flow cytometry would be reported in the same way as an abnormal cell population detected by a standard flow cytometry assay.

Cytogenetic Testing (Karyotyping or FISH)

Question 90: Was the disease status assessed by cytogenetic testing (karyotyping or FISH)?

Cytogenetic studies involve the study of chromosomes, typically through one of two methods: karyotyping or fluorescence in situ hybridization (FISH). Blood, bone marrow, or tissue preparations may be tested by either of these two methods. Karyotyping is both less sensitive and less specific than FISH testing; FISH studies identify only abnormalities detectable by the employed probe set, and cannot provide information about the presence or absence of chromosomal abnormalities or markers outside the specific probe set utilized.

Report “not applicable” if cytogenetic studies were never performed or have never shown abnormalities associated with the recipient’s primary transplant disease.

Once an assessment is positive for disease, “not applicable” will never be an appropriate response.

Report “no” if cytogenetic studies were not performed during the reporting period.

If the recipient’s best response is “Not in Complete Remission,” report the latest assessment performed during the reporting period and prior to any treatment for relapsed, progressive, or persistent disease (excluding treatment for minimal residual disease). If testing was not performed prior to the initiation of treatment, report “no” and go to question 97.

If the recipient’ best response is “Complete Remission,” report testing performed closest to the date of best response (question 83) and within the time windows in the Disease Assessment Time Windows table. If testing was not performed within the applicable time window, report “no” and go to question 97.

Question 91: Was the disease status assessed via FISH?

FISH XX/XY probe sets are not considered relevant to disease assessment and should not be reported in the disease assessment section.

Chromosomal microarrays / chromosomal genomic arrays should be reported as FISH assessments.

Report “not applicable” if FISH studies were never performed or have never shown abnormalities associated with the recipient’s primary transplant disease.

Once an assessment is positive for disease, “not applicable” will never be an appropriate response.

Report “no” if FISH studies were not performed during the reporting period.

If the recipient’s best response is “Not in Complete Remission,” report the latest assessment performed during the reporting period and prior to any treatment for relapsed, progressive, or persistent disease (excluding treatment for minimal residual disease). If testing was not performed prior to the initiation of treatment, report “no” and go to question 94.

If the recipient’ best response is “Complete Remission,” report testing performed closest to the date of best response (question 83) and within the time windows in the Disease Assessment Time Windows table. If testing was not performed within the applicable time window, report “no” and go to question 94.

Question 92: Date assessed

If the best response is “complete remission,” report the date of testing performed nearest the date of best response and prior to relapse or progression, if applicable.

If the best response is “not in complete remission,” report the date of the most recent testing performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease, if applicable. If no treatment for relapsed, progressive, or persistent disease was given, report the date of the most disease-specific testing performed within approximately 30 days of the follow-up date.

Report the date of specimen collection for FISH assessment. If exact date is not known, refer to General Instructions, General Guidelines for Completing Forms, for information about reporting partial or unknown dates.

Question 93: Was disease detected?

Report whether the recipient’s primary disease was detected by FISH testing on the date reported in question 92.

Question 94: Was the disease status assessed via karyotyping?

Report “not applicable” if karyotyping was never performed or have never shown abnormalities associated with the recipient’s primary transplant disease.

Once an assessment is positive for disease, “not applicable” will never be an appropriate response.

Report “no” if karyotyping was not performed during the reporting period.

If the recipient’s best response is “Not in Complete Remission,” report the latest assessment performed during the reporting period and prior to any treatment for relapsed, progressive, or persistent disease (excluding treatment for minimal residual disease). If testing was not performed prior to the initiation of treatment, report “no” and go to question 97.

If the recipient’ best response is “Complete Remission,” report testing performed closest to the date of best response (question 81) and within the time windows in the Disease Assessment Time Windows table. If testing was not performed within the applicable time window, report “no” and go to question 97.

Question 95: Date assessed

If the best response is “complete remission,” report the date of testing performed nearest the date of best response and prior to relapse or progression, if applicable.

If the best response is “not in complete remission,” report the date of the most recent testing performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease, if applicable. If no treatment for relapsed, progressive, or persistent disease was given, report the date of the most disease-specific testing performed within approximately 30 days of the follow-up date.

Report the date of specimen collection for karyotyping. If exact date is not known, refer to General Instructions, General Guidelines for Completing Forms, for information about reporting partial or unknown dates.

Question 96: Was disease detected?

Report whether the recipient’s primary disease was detected by karyotyping on the date reported in question 95. Do not include clinically insignificant polymorphism, or chromosomal abnormalities of no known significance, as disease detected; this includes anomalies such as age-dependent loss of the chromosome Y.

Radiologic

Question 97: Was the disease status assessed by radiological assessment (e.g. PET, MRI, CT)

Radiologic assessments are imaging techniques used to assess disease response to transplant, typically for lymphomas or solid tumors, though valuable in some less common presentations of disease, such as leukemia cutis. Imaging techniques used to evaluate disease response typically include PET, CT, or MIBG, but may include x-ray, skeletal survey, or ultrasound in some cases.

Report “not applicable” if radiological assessments were never performed or have never shown abnormalities associated with the recipient’s primary transplant disease.

Once an assessment is positive for disease, “not applicable” will never be an appropriate response.

Report “no” if radiological assessments were not performed during the reporting period.

If the recipient’s best response is “Not in Complete Remission,” report the latest assessment performed during the reporting period and prior to any treatment for relapsed, progressive, or persistent disease (excluding treatment for minimal residual disease). If testing was not performed prior to the initiation of treatment, report “no” and go to question 100.

If the recipient’ best response is “Complete Remission,” report testing performed closest to the date of best response (questions 83) and within the time windows in the Disease Assessment Time Windows table. If testing was not performed within the applicable time window, report “no” and go to question 100.

Question 98: Date assessed

If the best response is “complete remission,” report the date of the assessment performed nearest the date of best response and prior to relapse or progression, if applicable.

If the best response is “not in complete remission,” report the date of the most recent testing performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease, if applicable. If no treatment for relapsed, progressive, or persistent disease was given, report the date of the most disease-specific testing performed within approximately 30 days of the follow-up date.

Report the date of radiological assessment. For recipients with “complete remission” reported in question 80, this may match the date CR was achieved reported in question 83 for recipients with lymphomas, solid tumors, or other diseases with imaging criteria for reporting CR. If exact date is not known, refer to General Instructions, General Guidelines for Completing Forms, for information about reporting partial or unknown dates.

Question 99: Was disease detected?

Report whether the recipient’s primary disease was detected by radiologic assessment on the date reported in question 98.

Clinical / Hematologic

Question 100: Was the disease status assessed by clinical / hematologic assessment?

Clinical / hematologic disease assessments are the least sensitive method of disease detection. Examples include circulating blasts in the bloodstream for AML, and enlargement of a malignant mass for lymphoma or a solid tumor on physical examination. Every recipient who has an evaluation by a physician has a “clinical” assessment. Do not include radiologic or imaging assessments when reporting for question 100.

If the recipient’s best response is “Not in Complete Remission,” report the latest assessment performed during the reporting period and prior to any treatment for relapsed, progressive, or persistent disease (excluding treatment for minimal residual disease). If testing was not performed prior to the initiation of treatment, report “no” and go to question 103.

If the recipient’ best response is “Complete Remission,” report testing performed closest to the date of best response (question 83) and within the time windows in the Disease Assessment Time Windows table. If testing was not performed within the applicable time window, report “no” and go to question 103.

Question 101: Date assessed

If the best response is “complete remission,” report the date of the assessment performed nearest the date of best response and prior to relapse or progression, if applicable. This will likely match the date CR was achieved reported in question 81, since complete remission criteria generally require clinical or hematologic assessment to confirm.

If the best response is “not in complete remission,” report the date of the most recent testing performed during the reporting period and prior to treatment for relapsed, progressive, or persistent disease, if applicable. If no treatment for relapsed, progressive, or persistent disease was given, report the date of the most disease-specific testing performed within approximately 30 days of the follow-up date.

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

Question 102: Was disease detected?

Report whether clinical / hematologic abnormalities associated with the primary disease were detected. In general, if the clinical / hematologic assessment date is that same as that reported in question 83, for recipients achieving complete remission in the reporting period, the answer to question 102 should be “no.”

Section Updates:

Question Number Date of Change Add/Remove/Modify Description Reasoning (If applicable)
. . . . .
Last modified: Dec 22, 2020

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