All values reported in questions 77-102 must reflect the most recent testing prior to the start of systemic therapy (or infusion if no therapy was given). If the disease was not assessed prior to the infusion, report “no” and continue with question 103. If it is not known if the disease was assessed prior to the infusion, report “unknown” and continue with question 103.

Question 77: Was the disease assessed prior to the cellular therapy?

Indicate if the disease status was assessed prior to the cellular therapy. If “yes”, continue with question 78. If “no”, continue with question 103.

Question 78: Was the disease status assessed by molecular testing (e.g. 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 for genetic abnormalities 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. RFLP testing (with PCR amplification) is an example of a molecular test method used to detect BCR/ABL.

Report “yes” if a molecular method was used to determine disease status at the last evaluation prior to cellular therapy and continue with question 79. If a molecular method was not used to determine disease status, check “no” and continue with question 82.

Report “no” if a molecular testing was not performed or could not be used to determine disease status and continue with question 82.

Report “unknown” if testing was not performed near the start of the systemic therapy / infusion (within approximately 30 days) and after the most recent line of therapy (if applicable) and continue with question 82.

Report “not applicable” if molecular studies were never performed (since diagnosis) or have never shown abnormalities associated with the recipient’s primary disease for transplant and continue with question 82. Report “unknown” if testing was not performed near the start of the systemic therapy / infusion (within approximately 30 days) and after the most recent line of therapy (if applicable).

Question 79: Date sample collected:

Indicate the date (YYYY-MM-DD) the sample was collected for disease assessment by molecular method. The sample collection date should be prior to the start of any systemic therapy given immediately prior to the cellular therapy infusion (the earliest date reported in question 107).

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 80: Was disease detected?

Report whether the recipient’s primary disease was detected by molecular testing on the date reported in question 79. 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 the presence of only a single marker amongst numerous tested is sufficient to indicate disease detected.

If the recipient’s primary disease was detected by the molecular assessment reported in question 79, report “yes” and continue with question 81.

If the recipient’s primary disease was not detected by the molecular assessment reported in question 79, report “no” and continue with question 82.

Question 81: Was the status considered a disease relapse or progression?

If the physician believes the test results indicate disease relapse or progression, report “yes.” If the recipient
has a positive test result, but the physician does not believe the result represents relapse or progression (e.g., a recipient transplanted for CML exhibits such a low level of BCR-ABL positivity post-cellular therapy that the physician does not believe is disease), report “no”.

Question 82: Was the disease status assessed via flow cytometry (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.

Report “yes” if flow cytometry was used to determine disease status at the last evaluation prior to cellular therapy and continue with question 83.

Report “no” if flow cytometry was not performed or could not be used to determine disease status and continue with question 86.
Report “uknown” if testing was not performed near the start of the systemic therapy / infusion (within approximately 30 days) and after the most recent line of therapy (if applicable) and continue with question 86.

Report “not applicable” if flow cytometry was never performed (since diagnosis) or has never shown abnormalities associated with the recipient’s primary disease for transplant and continue with question 86.

Question 83: Date sample collected:

Indicate the date (YYYY-MM-DD) the sample was collected for disease assessment by flow cytometry. The sample collection date should be prior to the start of any systemic therapy given immediately prior to the cellular therapy infusion (the earliest date reported in question 107).

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 84: Was disease detected?

Report whether the recipient’s primary disease was detected by flow cytometry on the date reported in question 83. In order to be considered positive for disease, an abnormal cell population associated with the recipient’s primary transplant disease must be 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.

If the recipient’s primary disease was detected by the flow cytometry assessment reported in question 83, report “yes” and continue with question 85.

If the recipient’s primary disease was not detected by the flow cytometry assessment reported in question 83, report “no” and continue with question 86.

Question 85: Was the status considered a disease relapse or progression?

If the physician believes the test results indicate disease relapse or progression, report “yes.” If the recipient has a positive test result, but the physician does not believe the result represents relapse or progression, report “no.”

Question 86: 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. Although often used for finding specific features in DNA, FISH is not as sensitive as molecular methods, even though the markers identified may be the same. For more information of cytogenetic assessments, see Appendix C.

Report “yes” if cytogenetic testing was used to determine disease status at the last evaluation prior to cellular therapy and continue with question 87.

Report “no” if cytogenetic testing was not performed or was not used to determine disease status and continue with question 95.
Report “uknown” if testing was not performed near the start of the systemic therapy / infusion (within approximately 30 days) and after the most recent line of therapy (if applicable) and continue with question 95.

Report “not applicable” if cytogenetic testing was never performed (since diagnosis) or has never shown abnormalities associated with the recipient’s primary disease for transplant and continue with question 95.

Question 87: Was the disease status assessed by karyotyping?

Karyotyping is performed by culturing cells (growing cells under controlled conditions) until they reach the dividing phase. Techniques are then performed to visualize the chromosomes during cell division so that various bands and reconfigurations can be seen. Banding pattern differentiation and chromosomal reconfiguration demonstrate evidence of disease.

Report “yes” if karyotyping was used to determine disease status at the last evaluation prior to cellular therapy and continue with question 88.

Report “no” if karyotyping was not performed or was not used to determine disease status and continue with question 91.
Report “uknown” if testing was not performed near the start of the systemic therapy / infusion (within approximately 30 days) and after the most recent line of therapy (if applicable) and continue with question 91.

Report “not applicable” if karyotyping was never performed (since diagnosis) or has never shown abnormalities associated with the recipient’s primary disease for transplant and continue with question 91.

Question 88: Date sample collected:

Indicate the date (YYYY-MM-DD) the sample was collected for disease assessment by karyotyping. The sample collection date should be prior to the start of any systemic therapy given immediately prior to the cellular therapy infusion (the earliest date reported in question 107).

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 89: Was disease detected?

Report whether the recipient’s primary disease was detected by karyotyping on the date reported in question 88. 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.

If the recipient’s primary disease was detected by the karyotyping assessment reported in question 88, report “yes” and continue with question 90.

If the recipient’s primary disease was not detected by the karyotyping assessment reported in question 88, report “no” and continue with question 91.

Question 90: Was the status considered a disease relapse or progression?

If the physician believes the test results indicate disease relapse or progression, report “yes”. If the recipient has a positive test result, but the physician does not believe the result represents relapse or progression, report “no.”

Question 91: Was the disease status assessed by FISH?

Fluorescence in situ hybridization (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 “yes” if FISH was used to determine disease status at the last evaluation prior to cellular therapy and continue with question 92.

Report “no” if FISH studies were not performed or used to determine disease status or “unknown” if it is not known if FISH studies were performed, and continue with
question 95.

Report “unknown” if testing was not performed near the start of the systemic therapy / infusion (within approximately 30 days) and after the most recent line of therapy (if applicable) and continue with question 95.

Report “not applicable” if FISH studies were never performed (since diagnosis) or have never shown abnormalities associated with the recipient’s primary disease for transplant and continue with question 95.

Question 92: Date sample collected:

Indicate the date (YYYY-MM-DD) the sample was collected for disease assessment by FISH. The sample collection date should be prior to the start of any systemic therapy given immediately prior to the cellular therapy infusion (the earliest date reported in question 107).

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 93: Was disease detected?

If the recipient’s primary disease was detected by the FISH assessment reported in question 92, report “yes” and continue with question 94.

If the recipient’s primary disease was not detected by the FISH assessment reported in question 92, report “no” and continue with question 95.

Question 94: Was the status considered a disease relapse or progression?

If the physician believes the test results indicate disease relapse or progression, report “yes”. If the recipient has a positive test result, but the physician does not believe the result represents relapse or progression, report “no”.

Question 95: 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 “yes” if a radiologic assessment was used to determine disease status at the last evaluation prior to cellular therapy and continue with question 96.

Report “no” if a radiologic assessment was not performed or used to determine disease status or “unknown” if it is not known if a radiological assessment was performed, and continue with question 98.

Report “unknown” if testing was not performed near the start of the systemic therapy / infusion (within approximately 30 days) and after the most recent line of therapy (if applicable) and continue with question 98.

Report “not applicable” if radiologic assessments were never performed (since diagnosis) or have never shown abnormalities associated with the recipient’s primary disease for transplant and continue with question 98.

Question 96: Date assessed:

Indicate the date (YYYY-MM-DD) the disease was assessed by radiological assessment. The sample collection date should be prior to the start of any systemic therapy given immediately prior to the cellular therapy infusion (the earliest date reported in question 107).

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 97: Was disease detected?

If the recipient’s primary disease was detected by the radiologic assessment reported in question 96, report “yes”.

If the recipient’s primary disease was not detected by the radiologic assessment reported in question 96, report “no”.

Question 98: Was the disease status assessed by clinical / hematologic assessment?

Clinical / hematologic assessments are the least sensitive method of disease detection. Examples include circulating blasts in the bloodstream for AML or enlargement of a malignant mass for lymphoma / solid tumor as determined by physical exam. Every recipient who has an evaluation by a physician has a “clinical” assessment.

Report “yes” if a clinical / hematologic assessment was used to determine disease status at the last evaluation prior to cellular therapy and continue with question 99.

Report “no” if a clinical / hematologic assessment was not performed or used to determine disease status or “unknown” if it is unknown if a clinical/hematologic assessement was performed, and continue with question 100.

Question 99: Date assessed:

Indicate the date (YYYY-MM-DD) the disease was assessed by clinical/hematologic assessment. The sample collection or clinical examination date should be prior to the start of any systemic therapy given immediately prior to the cellular therapy infusion (the earliest date reported in question 100).

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 100: Was disease detected?

If the recipient’s primary disease was detected by the clinical / hematologic assessment reported in question
99, report “yes”.

If the recipient’s primary disease was not detected by the clinical / hematologic assessment reported in question 99, report “no”.

Question 101: What was the recipient’s disease status immediately prior to the cellular therapy?

Indicate the disease status of the primary transplant disease immediately prior to the cellular therapy. Disease response criteria vary by disease, and are outlined in the CIBMTR Forms Instruction Manual.

Question 102: Date assessed:

Indicate the date (YYYY-MM-DD) of the disease status reported in question 101. The date assessed should be prior to the start of any systemic therapy given immediately prior to the cellular therapy infusion (the earliest date reported in question 107).

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

Last modified: Jan 27, 2020

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