2157: Myeloproliferative Neoplasm (MPN) Post-Infusion

This form must be completed for all recipients who are randomized to the Comprehensive Report Form (CRF) track and whose primary disease is reported on the Pre-TED Disease Classification Form (Form 2402) as “Myeloproliferative Neoplasm (MPN) (1460)”. The Myeloproliferative Neoplasm (MPN) Post-HCT Data (Form 2157) must be completed in conjunction with each Post-HCT follow-up form completed (Form 2100). The form is designed to capture specific data occurring within the timeframe of each reporting period (i.e., between day 0 and day 100, between day 100 and the six-month date of contact, between the date of contact for the six-month follow up and the date of contact for the one-year follow up, etc.).

For recipients who had MPN that transformed to AML prior to transplant, only Form 2110 (Acute Myelogenous Leukemia Post-HCT Data) must be completed. Form 2057 (Myeloproliferative Neoplasm Pre-Infusion Data) is required to obtain MPN data pre-HCT, but Form 2157 (Myeloproliferative Neoplasm Post-HCT Data) is not required for these recipients.

Links to Sections of the Form:
Q1-86: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy
Q87-104: Post-HCT / Post-Infusion Therapy
Q105-201: Disease Detection Since the Date of Last Report
Q202-286: Disease Status at the Time of Evaluation for this Reporting Period

Manual Updates:
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.

If you need to reference the historical Manual Change History for this form, please click here or reference the retired manual section on the Retired Forms Manuals webpage.

Date	Manual Section	Add/Remove/Modify	Description
4/12/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Add	Instructions clarified on which assessment date to report in Q132: Report the date the sample was collected for molecular testing. If disease was detected multiple times by this method of assessment in the reporting period, report the first assessment which detected disease. If the exact date is not known, use the process for reporting partial or unknown dates as described in General Instructions, Guidelines for Completing Forms
4/9/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Question 105-202 blue box updated above Q105: Questions 105 – 202 are intended to capture information only for recipients who relapse / progress, have persistent or minimal residual disease in this reporting period. If disease was not detected by the method of assessment, report No. If disease was detected by the method of assessment, the earliest instance in which disease was detected in of disease detection by each method of assessment performed during the reporting period is reported. 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.
4/9/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Instructions updated in Q117 to clarify these questions should only be reported if disease was detected by this assessment: Testing for driver mutations may be performed by different methods including next generation sequencing (NGS), polymerase chain reaction (PCR), microarray, and fluorescence in situ hybridization (FISH). If testing by any / all of these methods was performed, to assess JAK2, CALR, MPL and CSF3R, and at least one of the driver mutations were detected (i.e. positive for disease), report Yes for question 117 and continue with question 118. If testing was completed during the reporting period but did not show evidence of disease, report No. If testing was not done during the reporting period or it is unknown whether testing was completed, report Unknown. If tests for driver mutations were not performed, or it is unknown if testing was done, report no or unknown respectively and go to question 130.
4/9/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Instructions updated in Q130 to clarify these questions should only be reported if disease was detected by this assessment: Molecular markers for disease refer to specific genetic sequences which are believed to be associated with the recipient’s primary disease. Testing for these sequences is often performed using PCR based methods; however, lower sensitivity testing, including FISH, may also be used to detect molecular markers. FISH testing for molecular markers should not be reported here. Once a marker has been identified, these methods can be repeated to detect minimal residual disease (MRD) in the recipient’s blood, bone marrow, or tissue. Molecular assessments include polymerase chain reaction (PCR) amplification to detect single specific disease markers; however, molecular methods are evolving and now include chromosomal microarray / chromosomal genomic array, Sanger sequencing, and next generation sequencing (e.g., Illumina, Roche 454, Proton / PGM, SOLiD). If any molecular testing for molecular markers was performed and disease was detected during the reporting period, report Yes and go to question 131. If molecular testing for molecular markers was not performed but did not detect disease at any time during the reporting period, report No*. If molecular testing was not done or it is not known if testing was done, report unknown.
4/9/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Instructions updated in Q131 to clarify these questions should only be reported if disease was detected by this assessment: If a positive molecular marker was identified, select Yes and continue with question 132. If there were no molecular markers identified-, or it is unknown whether molecular markers were identified,- select no or unknown respectively, and continue with question 139.
4/9/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Instructions updated in Q139 to clarify these questions should only be reported if disease was detected by this assessment: Flow cytometry assessment is a method of analyzing peripheral blood, bone marrow, or tissue preparations for multiple unique cell characteristics; its primary clinical purpose in the setting of MDS, MPN, and leukemias is to quantify blasts in the peripheral blood or bone marrow, or to identify unique cell populations through immunophenotyping. Flow cytometry assessment may also be referred to as “MRD” or minimal residual disease testing. If disease was detected via flow cytometry, select Yes and continue with question 140. If flow cytometry was done but disease was not detected or it is unknown if flow cytometry was done, select No and continue with question 148. If disease was not detected via flow cytometry or it is unknown if disease was detected via flow cytometry, select no and continues with question 148.
4/9/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Add	Instructions updated in Q149 to clarify these questions should only be reported if disease was detected by this assessment: Indicate whether FISH studies detected disease at any time during the reporting period. If FISH detected disease, select Yes go to question 150. Report No for question 149 and go to question 158 in any of the following cases: FISH testing was not performed during the reporting period; or FISH testing was done but abnormalities were not detected; 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.
4/9/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Add	Instructions updated in Q158 to clarify these questions should only be reported if disease was detected by this assessment: Indicate whether karyotyping studies detected abnormalities at any time during the reporting period. If karyotyping detected disease, select Yes go to question 159. Report no for question 158 and go to question 167 in any of the following cases: karyotyping was not performed during the reporting period; or karyotyping was performed but not abnormalities were detected; 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.
4/9/2024	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Add	Instructions updated in Q167 to clarify these questions should only be reported if disease was detected by this assessment: If a bone marrow biopsy detected disease during the reporting period, report Yes for question 167 and report the date of the positive assessment in question 168. Continue with question 169. 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 bone marrow biopsies detected disease, report the date of the earliest positive assessment performed during the reporting period. If bone marrow biopsies did not detect disease at any time during the reporting period, report No. or If it is unknown if any bone marrow biopsies were done, report no or unknown respectively and go to question 174.
9/21/2022	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Instructions for Q173 updated: Indicate if the myelofibrosis grade by WHO classification was bone marrow biopsy results were considered a disease relapse. Criteria for myelofibrosis relapse are established by clinical judgment. If the recipient has a myelofibrosis grade by WHO classification that the physician considers to be bone marrow biopsy was consistent with relapse, select “yes.” Continue with question 174.
9/20/2022	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Update instructions to be consistent with question text: If a disease was detected via bone marrow examination (color-red) was performed at the time of best response, select “yes” for question 73 and report the date the sample was collected in question 74. If a bone marrow examination was not performed disease was not detected or it is unknown if %(color-red)completed disease was detected via bone marrow examination at the time of best response, select “no” or “unknown” and continue with question 80.
5/6/2022	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Clarified instructions on how to report spleen response in question 3: A spleen response can be documented by a physician or but should be confirmed by MRI / computed tomography showing ≥35 % spleen volume reduction.
5/6/2022	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Add	Clarification added above question 105 (blue note box and instructional text) to report the first assessment showing evidence of disease: Questions 105 – 202 are intended to capture the earliest instance of disease detection by each method of assessment performed during the reporting period. 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. For each method of assessment, report “Yes” if that method detected the recipient’s MPN (or markers of MPN) 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 splenomegaly, hepatomegaly, driver mutations, molecular or cytogenetic markers / abnormalities, or disease detected via bone marrow was not done during the reporting period or it is not known whether testing was performed, report “Unknown” for those methods. If testing by flow cytometry or for disease detected extramedullary or by other assessment was not done during the reporting period or it is not known whether testing was performed, report “No” for those methods.
11/23/2020	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Instructions updated for question 281 on when to use the “not assessed” option for reporting they cytogenetic response: If cytogenetic response was not tested at the last evaluation time of best response to this line of therapy select “Not assessed” and continue with question 283.
10/5/2020	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Add	Clarification added on when to report “yes” and “no” for question 203: Report “yes” for question 203 and go to question 276 in any of the following scenarios: Disease was detected by any method in the reporting period (reported in the Disease Detected Since the Date of Last Report, questions 105-181) and no therapy was given to treat disease between the date(s) of the assessments reported in the Disease Detection Since the Date of Last Report (questions 105-181) for the form and the date of contact for this reporting period the most recent disease assessments in the reporting period have already been reported in questions 105-202 (Disease Detection Since the Date of Last Report) Disease was detected by any method in the reporting period (reported in the Disease Detection Since the Date of Last Report, questions 105-181), therapy was administered, but no assessments were performed after the initiation of therapy if assessments were reported in questions 105-202 (Disease Detection Since the Date of Last Report) and no therapy was given to treat disease between the date(s) of the reported assessments and the date of contact for this reporting period Report “no” for question 203 and report the most recent disease assessments in the reporting period in questions 204 – 275 in any of the following scenarios Disease was not detected by any method of assessment during the reporting period Disease was detected (color-red) in the reporting period (reported in the Disease Detected Since the Date of Last Report, questions 105-181), therapy was administered, and additional assessment(s) were performed after therapy by at least one method of assessment during the reporting period (reported in questions 105-202), but the most recent assessments have not yet been reported on the form
8/18/2020	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Blue information box added above questions 19, 117, and 214 to provide instructions on how to report CALR testing: If CALR testing was performed but the lab report does not specify the type, select “not done” for questions 25 and 26 and specify the results as either “positive” or “negative” for question 27.
8/18/2020	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Red warning box added above questions 262-23, explaining the question text is currently incorrect and will be revised with next revision of the form: The question text for questions 262 – 263 are incorrect. Currently, the question reads “Was disease detected via bone marrow examination;” however, the question should say “Was disease assessed via bone marrow examination.” This question will be updated with the next revision of this form.
8/18/2020	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Blue information box added above questions 19, 117, and 214 to provide instructions on how to report CALR testing: If CALR testing was performed but the lab report does not specify the type, select “not done” for questions 25 and 26 and specify the results as either “positive” or “negative” for question 27.
6/8/2020	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Updated the instructions for question 262 by as the instructions were incorrect. Indicate if disease was detected by a bone marrow examination. If disease was detected, If a bone marrow biopsy was performed at the time of evaluation for this reporting period, report “yes” for question 262 and report the date of the assessment in question 263. Continue with question 264.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 disease was detected on multiple bone marrow biopsies were performed during the reporting period, report the date of the assessment performed closest to the date of contact. If disease was not detected by a bone marrow examination biopsies were not performed at any time during the reporting period, or it is unknown if disease was detected any bone marrow biopsies were done, report “no” or “unknown” respectively and go to question 268.
6/3/2020	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Add	Provided clarification (see red text) on when to answer “not applicable” for questions 30 and 128. If testing for all of the listed driver mutations are negative, select “Not applicable (negative results).”
5/10/2020	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Add	Version 1 of the 2157: MPN Post-HCT section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the Form 2157.

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