2014: Myelodysplastic Syndrome (MDS) Pre-Infusion

The Myelodysplastic Pre-Infusion Data Form is one of the Comprehensive Report Forms. This form captures MDS-specific pre-infusion data such as: disease assessment at diagnosis, laboratory studies at diagnosis, pre-infusion therapy, disease transformation, most recent disease assessments, laboratory studies, and disease status prior to the preparative regimen.

This form must be completed for all recipients 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 (MDS) diseases (50) (Please classify all preleukemias)” and recipients with AML whose disease progressed from MDS.

Q1: Subsequent Transplant or Cellular Therapy
Q2-17: Disease Assessment at Diagnosis
Q18-47: Diagnostic Studies
Q48-81: IPSS-R Prognosis Score
Q82-156: Pre-HCT / Pre-Infusion Therapy
Q157-193: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
Q194-208: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen

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
6/28/2023	2014: Myelodysplastic Syndrome (MDS) Pre-Infusion	Add	The Reporting Prior Cellular Therapy as a Line of Therapy blue information box added to Q143: As of June 28, 2023, the ‘cellular therapy’ option within the Pre-Infusion Lines of Therapy section is no longer enabled. Recipients who received a cellular therapy prior to the current infusion is no longer required to be reported as a line of therapy on the pre-infusion disease specific form
4/21/2023	2014: Myelodysplastic Syndrome (MDS) Pre-Infusion	Modify	Clarified the instructions for the labs at diagnosis should reflect the labs closest to the date of diagnosis in Q18.
10/7/2020	2014: MDS Pre-Infusion	Add	Clarification added to question 82 to explain how to report lines of therapy for subsequent infusions: Lines of Therapy and Subsequent Infusions If this is a subsequent infusion and a 2014 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2014. Please report from post previous infusion to time of preparative regimen / infusion for the current infusion. If a 2014 was not previously completed, all lines of therapy from diagnosis to the current preparative regimen / infusion must be completed.
9/9/2020	2014: MDS Pre-Infusion	Add	Clarification added on how to report relapse / progression following the line of therapy for recipients who transform to AML in question 155: Refer to the MDS Response Criteria section when determining the recipient’s disease status. Indicate if the disease relapsed from CR or progressed from hematologic improvement. If the disease relapsed, progressed, or transformed to AML (see red box below) answer “Yes” and go to question 156. If “No,” go to question 157.
8/19/2020	2014: MDS Pre-Infusion	Modify	The instruction for which question should be answered next if HI-N or HI-P was updated as the previous instructions were incorrect: If the cell lines examined to determine hematologic improvement only included “Hematologic Improvement, Platelets (HI-P)” and / or “Hematologic Improvement, Neutrophils (HI-N)” continue with question 155 154.
5/9/2020	2014: MDS Pre-Infusion	Modify	Version 3 of the 2014: MDS Pre-Infusion section of the Forms Instructions Manual released. Version 3 corresponds to revision 4 of the Form 2014.
8/10/18	2014: MDS/MPN Pre-HCT	Added	Added an instructional blue box for question 123: Myelofibrosis that develops in patients with essential thrombocythemia (ET) or polycythemia vera (PV) is considered secondary myelofibrosis. The CIBMTR forms capture disease subtype using the WHO classification of myeloid neoplasms and acute leukemia. Secondary myelofibrosis is not included as a separate category per the WHO classification. Therefore, when reporting the disease subtype at the time of transplant for recipients with secondary myelofibrosis, report “Primary Myelofibrosis (PMF)” to accurately capture these cases on the CIBMTR Forms.
9/7/17	2014: MDS/MPN Pre-HCT	Modify	Replaced note box regarding transformation of essential thrombocytopenia and polycythemia vera to myelofibrosis located below instructions for question 123 with Transformation to Myelofibrosis notebox. New text is highlighted red below while old text is struck out. Recipients transplanted for post-essential thrombocythemia myelofibrosis (post-ET MF) or post-polycythemia vera myelofibrosis (post-PV MF) will be reported as ET or PV at diagnosis (Q2). Question 123: ‘Did the recipient progress or transform to a different MDS/MPN subtype between diagnosis and the start of the preparative regimen?’ must be answered “Yes”. Myelofibrosis that develops in patients with essential thrombocythemia (ET) or polycythemia vera (PV) is considered secondary myelofibrosis. Do not report this as a transformation; when a patient with ET or PV develops fibrosis, do not report primary myelofibrosis as the primary indication for transplant.
8/1/17	2014: MDS/MPN Pre-HCT	Modify	Added text (in red below) and removed text (struck out below) from instructions for question 121. Refer to the MDS / MPN Response Criteria section when determining the recipient’s disease status. Indicate if the disease relapsed from CR or progressed from hematologic improvement. If the disease relapsed or progressed, answer “Yes” and go to question 122. If “No,” go to question 123. Progression or relapse should be reported even if it was reported in the previous set of questions regarding response to therapy (questions 118-120). Relapse is the recurrence of disease after CR. MDS/MPN relapse requires one of the following: Return to pre-treatment bone marrow blast percentage. Decrease of ≥ 50% from maximum response levels in granulocytes or platelets Transfusion dependence, or hemoglobin level ≥ 1.5 g/dL lower than prior to therapy. Progression is the worsening of the disease following hematologic improvement or stable disease. Progression requires at least one of the following in the absence of another explanation (e.g., infection, bleeding, ongoing chemotherapy, etc.): ≥ 50% reduction from maximum response levels in granulocytes or platelets Reduction in hemoglobin by ≥ 1.5 g/dL Transfusion dependence Progression to AML: ≥ 20% blasts in the blood or bone marrow
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)
6/24/16	2014: MDS/MPN Pre-HCT	Add	Added information box to Q157: “Never Treated” is not an option choice on revision three of the Myelodysplasia / Myeloproliferative Disorders Pre-HSCT Data (MDS) Form. When completing revision three of this form, centers should report “No Response (NR) / Stable Disease (SD)” for recipients who have only received supportive care prior to transplant.
3/31/16	2014: MDS/MPN Pre-HCT	Add	Added an information box about transformation of polycythemia vera and essential thrombocythemia to question 123 : Myelofibrosis that develops in patients with essential thrombocythemia (ET) or polycythemia vera (PV) is considered secondary myelofibrosis. Do not report this as a transformation; when a patient with ET or PV develops fibrosis, do not report primary myelofibrosis as the primary indication for transplant.
9/27/15	2014: MDS/MPN Pre-HCT	Modify	Modified MDS transformation table to include RA, 5q- syndrome, MDS-U, and chronic eosinophilia transformations
6/26/15	2014: MDS/MPN Pre-HCT	Modify	Modified text of Questions 121 and 123 to include the following concept: Progression to AML: ≥ 20% blasts in the blood or bone marrow

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