2114: Myelodysplastic Syndrome (MDS) 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 “Myelodysplastic Syndrome (MDS) (50)” The Myelodysplastic Syndrome (MDS) Post-HCT Data (Form 2114) 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 MDS that transformed to AML prior to transplant, only Form 2014 (Myelodysplastic Syndrome Pre-HCT Data) must be completed to obtain MDS data pre-HCT. Form 2114 (Myelodysplastic Syndrome Post-HCT Data) is not required for these recipients post-HCT.

Q1-72: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy
Q73-87: Post-HCT / Post-Infusion Therapy
Q88-171: Disease Detection Since the Date of Last Report
Q172-236: 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 Forms Manuals/Documents/2114.MDS Pre-HCT Data Manual Change History through 3.31.15.pdf or reference the retired manual section on the Retired Forms Manuals Forms Manuals/pages/index.aspx .

Date	Manual Section	Add/Remove/Modify	Description
4/12/2024	MDS Post-HCT	Add	Disease Detection Since the Date of Last Report blue box and introduction added to the top of the Disease Detected section: Disease Detection Since the Date of Last Report:This section is 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 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; For each method of assessment, report Yes if that method detected the recipient’s MDS (or markers of MDS) during the reporting period. If testing by a particular method (e.g., molecular makers, cytogenetic, flow cytometry, etc.) was done, but did not show evidence of disease during the reporting period, report No for that method. If testing for splenomegaly, hepatomegaly, molecular or cytogenetic markers / abnormalities, or 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, extramedullary disease detection or other assessment was not done during the reporting period or it is not known whether testing was performed, report No for those methods.
4/12/2024	MDS Post-HCT	Modify	Instructions updated for molecular markers in Q100: If any molecular testing for molecular markers was performed and disease was detected during the reporting period, report Yes and go to question 101. If molecular testing for molecular markers was performed but did not detect disease at any time during the reporting period, report No. If molecular testing for molecular markers was not performed at any time during the reporting period, or it is unknown if testing was done, report No or Unknown respectively and go to question 109.
4/12/2024	MDS Post-HCT	Add	Clarification added to explain which date to report in Q102: 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.
10/5/2023	Q88-171: Most Recent Laboratory Studies	Modify	Provided clarity on how to report when no flow assessments were completed : 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 the disease was detected via flow cytometry, select Yes and continue to the next question. If disease was not detected via flow cytometry, flow cytometry wasn’t performed at any time during the reporting period, or it is unknown if disease was detected via flow cytometry, select No and continue to Was disease detected via cytogenetic testing (karyotyping or FISH)?
10/5/2023	Q88-171: Most Recent Laboratory Studies	Modify	Provided clarity on how to report when no bone marrow assessments were completed: If a bone marrow biopsy detected disease during the reporting period, report Yes for Was disease detected via bone marrow examination? and report the date of the positive assessment. 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. If no bone marrow biopsies were done during the reporting period, or it is unknown if any bone marrow biopsies were done, report “no” or Unknown respectively and go to Was extramedullary disease indicative of AML detected? (e.g. myeloid sarcoma).
9/21/2022	MDS Post-HCT	Modify	Instructions for Q143 updated as original instructions were incorrect: 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 is consistent with relapse, select “yes.” Continue with question 144.
9/16/2022	MDS Post-HCT	Modify	Instructions for Q59 updated to be consistent with question text: If disease detected a bone marrow examination was performed at the time of best response, select “yes” for question 59 and report the date the sample was collected in question 60. If a bone marrow examination disease was not performed or it is unknown if disease was detected via performed at the time of best response, select “no” or “unknown” and continue with question 65.
10/5/2020	MDS Post-HCT	Add	Clarification added on when to report “yes” and “no” for question 172: Report “Yes” for question 172 and go to question 233 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 88 – 151) 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 88 – 151) 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 88-151 (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 88 – 151), therapy was administered, but no assessments were performed after the initiation of therapy if assessments were reported in questions 88-151 (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 172 and report the most recent disease assessments in the reporting period in questions 173 – 232 in any of the following scenarios: Disease was not detected by any method of assessment during the reporting period Disease was detected in the reporting period (reported in the Disease Detected Since the Date of Last Report, questions 88 – 151), 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 88-151), but the most recent assessments have not yet been reported on the form In addition, the graphic was added.
8/18/2020	MDS Post-HCT	Add	Red warning box added above questions 219-220 to clarify the instruction text is currently incorrect but will be updated with the next revision of the form: The question text for questions 219 – 220 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.
5/9/2020	MDS Post-HCT	Modify	Version 3 of the 2114: MDS Post-HCT section of the Forms Instruction Manual released. Version 3 corresponds to revision 4 of the Form 2114.
3/19/18	Comprehensive Disease Specific Manuals	Add	Added the following instruction for applicable post-infusion disease-specific forms where current disease status is asked (2110, 2111, 2112, 2113, 2114, 2115, 2116, 2118, 2119). The center does not need to repeat all disease-specific assessments (biopsies, scans, labs) each reporting period in order to complete current disease status data fields. Once a particular disease status is achieved, the center can continue reporting that disease status (based on labs / clinical assessments) until there is evidence of relapse / progression.
2/24/17	Comprehensive Disease-Specific Manuals	Modify	Updated explanations of triggers for disease inserts to refer to the primary disease reported on the Pre-TED Disease Classification Form (Form 2402) instead of the Pre-TED Form (Form 2400)
6/26/15	2114: MDS/MPN Post-HCT	Modify	Modified text of Question 30 to include the following concept: Progression to AML: ≥ 20% blasts in the blood or bone marrow

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