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Q108-130: Engraftment Syndrome

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q108-130: Engraftment Syndrome

!Questions 108-130 can only be completed on the 100 day follow-up form. These questions will be skipped for all subsequent reporting periods. Question 108-109: Did engraftment syndrome occur? Engraftment syndrome typically occurs during neutrophil recovery post-HCT…

Q43: Acute Chest Syndrome

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion » Q43: Acute Chest Syndrome

Question 43: New onset of acute chest syndrome: Acute chest syndrome (ACS) is a term used to identify symptoms of chest pain, cough, fever, decreased oxygen (hypoxia), and lung infiltrates. Due to the sickling nature of red blood cells as a result of sickle cell…

Q74-100: Other Laboratory Studies

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion » Q74-100: Other Laboratory Studies

Questions 74 – 75: Was hemoglobin electrophoresis performed? Indicate if hemoglobin electrophoresis studies were performed since the date of last report. If hemoglobin electrophoresis studies were performed, report Yes and provide the date of the most recent…

Q169-174: Status of Hematologic Engraftment

Comprehensive Disease-Specific Manuals » 2033/2133: Wiskott-Aldrich Syndome (WAS) » 2133: WAS Post-HCT » Q169-174: Status of Hematologic Engraftment

This section refers to quantitative analyses utilizing discriminating DNA markers. Peripheral blood cells must undergo separation or sorting into T, B, or lymphoid vs. myeloid populations to perform this determination. If RFLP analyses indicate only donor type…

Q167-172: Status of Hematologic Engraftment

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2131: ID Post-HCT » Q167-172: Status of Hematologic Engraftment

This section refers to quantitative analysis utilizing discriminating DNA markers. Peripheral blood cells must undergo separation or sorting into T, B, or lymphoid vs. myeloid populations to perform this determination. If RFLP analysis indicate only donor type…

2014/2114: Myelodysplastic Syndrome (MDS)

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS)

The myelodysplastic syndromes (MDS) are a diverse group of clonal hematopoietic stem cell diseases characterized by cytopenia(s), dysplasia (abnormal growth or development leading to an alteration in size, shape, and organization of the cell) in one or more of the…

Q57-61: Acute Chest Syndrome

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q57-61: Acute Chest Syndrome

Question 57: Has acute chest syndrome (ACS) occurred in the last two years? Acute chest syndrome (ACS) is a term used to identify symptoms of chest pain, cough, fever, decreased oxygen (hypoxia), and lung infiltrates. Due to the sickling nature of red blood cells as a…

2014: Myelodyplastic Syndrome (MDS) Pre-Infusion

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2014: Myelodyplastic 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…

2114: Myelodysplastic Syndrome (MDS) Post-Infusion

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 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…

Q74-148: Pre-HCT or Pre-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2013: CLL Pre-Infusion » Q74-148: Pre-HCT or Pre-Infusion Therapy

*Richter’s Transformation If completing this form for a recipient whose disease has undergone Richter’s transformation prior to HCT, only report therapy administered prior to transformation on the CLL Pre-Infusion Data Form. Any therapy given post-transformation…

Q125-156: POEMS Syndrome Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2016: PCD Pre-Infusion » Q125-156: POEMS Syndrome Assessment at Diagnosis

!Complete questions 125-156 for POEMS patients only. If POEMS was not reported as the primary disease for transplant (question 1) or as a preceding / concurrent disorder (question 2), skip to question 157. Questions 125-126: Specify POEMS clinical features (check all…

Q312 – 343: Current Status of POEMS Syndrome for This Reporting Period

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2116: PCD Post-Infusion » Q312 – 343: Current Status of POEMS Syndrome for This Reporting Period

!Complete questions 312-343 for POEMS patients only. If POEMS was not reported as the primary disease for transplant (question 1) or as a preceding / concurrent disorder (question 2), submit the form. Questions 312-313: Specify POEMS clinical features (check all that…

Q106-167: Post-HCT Treatment for Wiskott-Aldrich Syndrome

Comprehensive Disease-Specific Manuals » 2033/2133: Wiskott-Aldrich Syndome (WAS) » 2133: WAS Post-HCT » Q106-167: Post-HCT Treatment for Wiskott-Aldrich Syndrome

Question 106: Was any treatment given for relapsed, persistent, or progressive disease (since the date of last report)? Following transplant, additional therapy may be given for relapsed, persistent, or progressive disease. Low lymphocyte counts, new or persistent…

Q48-49: Veno-occlusive disease (VOD) / Sinusoidal obstruction syndrome (SOS)

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q48-49: Veno-occlusive disease (VOD) / Sinusoidal obstruction syndrome (SOS)

Veno-occlusvie disease (VOD) / Sinusoidal obstruction syndrome (SOS) occurs following injury to the hepatic venous endothelium, resulting in hepatic venous outflow obstruction due to occlusion of the hepatic venules and sinusoids. This typically results in a…

Q110-141: POEMS Syndrome Assessment at the Time of Best Response

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2116: PCD Post-Infusion » Q110-141: POEMS Syndrome Assessment at the Time of Best Response

!Complete questions 110-141 for POEMS patients only. If POEMS was not reported as the primary disease for transplant (question 1) or as a preceding / concurrent disorder (question 2), skip to question 142. The response time for POEMS tends to occur well after…

Q291-296: POEMS Syndrome Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2016: PCD Pre-Infusion » Q291-296: POEMS Syndrome Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

!Complete questions 291-296 for POEMS patients only. If POEMS was not reported as the primary disease for transplant (question 1) or as a preceding / concurrent disorder (question 2), submit the form. Questions 291-292: Vascular endothelial growth factor (VEGF) serum…

2133: WAS Post-HCT

Comprehensive Disease-Specific Manuals » 2033/2133: Wiskott-Aldrich Syndome (WAS) » 2133: WAS Post-HCT

This form must be completed for all recipients randomized to the Comprehensive Report Form (CRF) track whose primary disease is reported on the Pre-TED Disease Classification Form (Form 2402) as Wiskott-Aldrich Syndrome under “disorders of the immune system.” The…

2131: ID Post-HCT

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2131: ID Post-HCT

The Immune Deficiency Post-HCT Data Form is one of the Comprehensive Report Forms. This form captures ID-specific post-HCT data such as: laboratory studies post-HCT, clinical features assessed post-HCT, Post-HCT treatment, and status of hematologic engraftment. This…

2130: SCD Post-Infusion

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion

The Sickle Cell Disease Post-HCT Data Form is one of the Comprehensive Report Forms. This form captures Sickle Cell Disease (SCD) post-HCT data for the reporting period. This form must be completed for all recipients whose primary disease, as reported on the Pre-TED…

Q488-495: Disorders of Immune System

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q488-495: Disorders of Immune System

Questions 488-491: Specify disorder of immune system classification: Indicate the disorder of the immune system’s disease classification at diagnosis. If the subtype is not listed, report as “other SCID”, “other immunodeficiency” or “other pigmentary…

2100: Post-HCT Follow-Up

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up

A transplant center designated as a Comprehensive Report Form center will submit data on the Pre-TED and Pre-TED Disease Classification Forms, followed by either the Post-TED Form or the Comprehensive Report Forms. The type of follow-up forms required for a specific…

Q449-450: Inherited Bone Marrow Failure Syndromes

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q449-450: Inherited Bone Marrow Failure Syndromes

*Note: Primary Disease for Infusion: If the recipient was diagnosed with an inherited bone marrow failure syndrome and developed MDS or AML, report the primary disease for infusion as MDS or AML, respectively. Questions 449: Specify the inherited bone marrow failure…

2033/2133: Wiskott-Aldrich Syndome (WAS)

Comprehensive Disease-Specific Manuals » 2033/2133: Wiskott-Aldrich Syndome (WAS)

Wiskott-Aldrich syndrome (WAS) is a rare X-linked recessive immunodeficiency affecting 1 to 10 of every 1 million male newborns. It is characterized by microthrombocytopenia and defective lymphocyte function. The decreased numbers and reduced size of platelets…

2034/2134: X-Linked Lymphoproliferative Sydrome (XLP)

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP)

X-linked lymphoproliferative syndrome, also known as XLP or Duncan’s syndrome, is a rare inherited immunodeficiency. It is characterized by severe immune dysregulation, which generally manifests as an exaggerated immune response to infection. XLP belongs to the group…

Q131-139: Additional Drugs Given in the Peri-Transplant Period

Transplant Essential Data (TED) Manuals » 2400: Pre-TED » Q131-139: Additional Drugs Given in the Peri-Transplant Period

Drugs may be given during the peri-transplant period to prevent transplant-related complications, such as liver injuries or to facilitate engraftment. Questions 131-139: Drugs For each agent listed, indicate whether the drug was administered during the…

2033: WAS Pre-HCT

Comprehensive Disease-Specific Manuals » 2033/2133: Wiskott-Aldrich Syndome (WAS) » 2033: WAS Pre-HCT

The Wiskott-Aldrich Syndrome Pre-HCT Data Form is one of the Comprehensive Report Forms. This form captures WAS-specific pre-HCT data such as: the recipient’s clinical and genetic findings at the time of diagnosis and prior to the start of the preparative regimen,…

Appendix D: How to Distinguish Infusion Types

Appendices » Appendix D: How to Distinguish Infusion Types

This appendix includes definitions of Hematopoietic Stem Cell Transplant (HCT), Cellular Therapies, Supplemental Infusions, and Autologous Cells Given for Graft Failure. For more information see Table 1. Table 1. Distinguishing Infusion Types* *A preparative…

Q3-23: Clinical Features Present at Diagnosis

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2019: WM Pre-HCT » Q3-23: Clinical Features Present at Diagnosis

Question 3: Was peripheral neuropathy present? Peripheral neuropathy often starts as tingling or burning in the distal extremities, and may progress to extremity numbness and weakness. The etiology of peripheral neuropathy in WM/LPL is not well understood in the…

Cause of Death Codes

Comprehensive Baseline & Follow-up Manuals » 2900: Recipient Death » Cause of Death Codes

Recurrence / persistence / progression of disease for which the HCT or cellular therapy was performed. If the disease is present at death, but not the underlying cause of death, “Recurrence/persistence/progression of disease for which the HCT or cellular therapy was…

2034: XLP Pre-HCT

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2034: XLP Pre-HCT

The X-Linked Lymphoproliferative Syndrome Pre-HCT Data Form is one of the Comprehensive Report Forms. This form captures XLP-specific pre-HCT data such as: the recipient’s clinical and genetic findings at the time of diagnosis and prior to the start of the…

Q441-615: Organ Function

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q441-615: Organ Function

Links within section: Pulmonary Function Liver Toxicity Prophylaxis Liver Function Thrombotic Microangiopathy Other Organ Impairment / Disorder Pulmonary Function *Bacterial, Viral, and Fungal Pneumonia Report pneumonia due to infection in the Infection section…

Q14-16: Initial ANC Recovery

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q14-16: Initial ANC Recovery

!Initial ANC Recovery Questions 14-15 can only be completed on the 100 day, 6 month, 1 year, and 2 year follow-up forms. These questions will be skipped for all subsequent reporting periods. Question 16 must be answered on all follow-up forms. *Initial ANC…

Appendix H: MDS/MPN Subtypes

Appendices » Appendix H: MDS/MPN Subtypes

The following MDS / MPN subtypes are used on the Pre-TED Disease Classification (2402) Form, AML Pre-Infusion (2010), the MDS Pre-Infusion (2014) Form, and the MPN Pre-Infusion (2057) Form.1 Myelodysplastic Syndrome (MDS) Subtypes Myelodysplastic Syndrome with…

Q446-448: Severe Aplastic Anemia

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q446-448: Severe Aplastic Anemia

Questions 446-448: Specify the aplastic anemia classification: Indicate the aplastic anemia classification of the primary disease for infusion. If any of the following classifications are selected: Acquired AA, not otherwise specified (301) Acquired AA secondary…

2134: XLP Post-HCT

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2134: XLP Post-HCT

This form must be completed for all recipients randomized to the Comprehensive Report Form (CRF) track whose primary disease is reported on the Pre-TED Disease Classification Form (Form 2402) as “disorders of the immune system” and question 628 as X-Linked…

Comprehensive Disease-Specific Manuals

Comprehensive Disease-Specific Manuals

The sections below provide explanatory text for disease specific forms. For many disease inserts, subsections include disease response criteria which are linked to from within the disease insert itself, or from other forms which reference the disease criteria (i.e.,…

2553: VOD/SOS

Infection & Miscellaneous Manuals » 2553: VOD/SOS

The Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome (SOS) Form, Form 2553, must be completed when VOD / SOS has been reported to have developed on the 100 Day Post-HCT Data Form (F2100) or the 100 Day Post-TED Form (Form 2450). Additionally, a Six Month…

2028: Aplastic Anemia Pre-Infusion

Comprehensive Disease-Specific Manuals » 2028/2128: Aplastic Anemia » 2028: Aplastic Anemia Pre-Infusion

This section of the CIBMTR Forms Instruction Manual is intended to be a resource for completing the Aplastic Anemia Pre-Infusion Data Form (Form 2028 – Revision 3). *Email comments regarding the content of the CIBMTR Forms Instruction Manual to:…

Q80-170: Toxicities

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q80-170: Toxicities

*Report any observed toxicity or infection that occurs post-infusion in this reporting period, regardless of causality and whether or not treatment was administered. The intent is to capture all toxicities diagnosed after the cellular therapy infusion. Although…

2019/2119: Waldenström’s Macroglobulinemia (WM)

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM)

Lymphoplasmacytic lymphoma (LPL) and subtype Waldenström’s macroglobulinemia (WM) are specific presentations of Non-Hodgkin lymphoma that are characterized by abnormal cellular populations containing small B-cells, plasma cells, and plasmacytoid lymphocytes.…

Q146: Prior Exposure: Potential Study Eligibility

Transplant Essential Data (TED) Manuals » 2400: Pre-TED » Q146: Prior Exposure: Potential Study Eligibility

Question 146: Specify if the recipient received any of the following (at any time prior to HCT / infusion) (check all that apply) Indicate if any of the following agents were administered to the patient prior to HCT / infusion: Blinatumomab (Blincyto): A monoclonal…

2031: ID Pre-HCT

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2031: ID Pre-HCT

The Immune Deficiency Pre-HCT Data Form is one of the Comprehensive Report Forms. This form captures ID-specific pre-HCT data such as: disease assessment at diagnosis, laboratory studies at diagnosis, clinical features assessed between diagnosis and the start of the…

Q89-107: Chimerism Studies

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q89-107: Chimerism Studies

*Autologous Transplants If this was an autologous HCT, continue with the Engraftment Syndrome section starting with question 108. Chimerism testing and graft-versus-host disease sections should only be completed for allogeneic HCTs. *Syngeneic Transplants If this was…

Q1-3: Complications of Interest

Infection & Miscellaneous Manuals » 2542: Mogamulizumab Supplemental Data Collection » Q1-3: Complications of Interest

Question 1: Were there any Grade ≥ 3 potentially immune-mediated complications of interest? Indicate whether the recipient experienced a Grade ≥ 3 potentially immune-mediated complication of interest during the timeframe captured by the specific visit ID of form…

Q83-88: Data from Post-HSCT Follow-Up Form (2100)

Infection & Miscellaneous Manuals » 2540: Tepadina® Supplemental Data » Q83-88: Data from Post-HSCT Follow-Up Form (2100)

Questions 83-88 refer to data reported on form 2100, Q441-615, please ensure data reported here matches with form 2100. Questions 83-85: In the transplant physician’s judgment, were any of the disorders / impairments reported on the form 2100 a direct result of…

Q140-142: GVHD Prophylaxis

Transplant Essential Data (TED) Manuals » 2400: Pre-TED » Q140-142: GVHD Prophylaxis

!The following GVHD prophylaxis questions are to be completed for allogeneic HCTs only. Autologous and syngeneic HCTs continue with question 143. *If ATG or Campath were ordered for GVHD prophylaxis prior to or after Day 0, report these drugs in the Additional Drugs…

2013: CLL Pre-Infusion

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2013: CLL Pre-Infusion

The Chronic Lymphocytic Leukemia Pre-Infusion Data Form is one of the Comprehensive Report Forms. This form captures CLL-specific pre-infusion data such as: disease assessment at diagnosis, laboratory studies at diagnosis, pre-infusion treatment for CLL, most recent…

2029: Fanconi Anemia / Constitutional Anemia Pre-HCT

Comprehensive Disease-Specific Manuals » 2029/2129: Fanconi Anemia / Constitutional Anemia » 2029: Fanconi Anemia / Constitutional Anemia Pre-HCT

The Fanconi Anemia / Constitutional Anemia Pre-HCT Form is one of the Comprehensive Report Forms. This form captures Fanconi Anemia-specific pre-infusion data such as: disease assessment at diagnosis, laboratory studies at diagnosis, pre-infusion therapy, most recent…

Q1-13: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2033/2133: Wiskott-Aldrich Syndome (WAS) » 2033: WAS Pre-HCT » Q1-13: Disease Assessment at Diagnosis

Question 1: What was the date of diagnosis? Wiskott-Aldrich syndrome (WAS) is characterized by multiple clinical, laboratory, and genetic features, rather than distinct pathological characteristics. Examples of testing done to confirm a diagnosis of WAS include…

Q45-47: Liver Toxicity Prophylaxis

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q45-47: Liver Toxicity Prophylaxis

!Liver Toxicity Prophylaxis Questions 45-47 can only be completed on the 100 day and 6 month follow-up forms. These questions will be skipped for all subsequent reporting periods. Question 45: Was specific therapy used to prevent liver toxicity? Liver toxicities in…

Q179-258: Myelodysplastic Diseases

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q179-258: Myelodysplastic Diseases

*Transformation to AML If the recipient is being transplanted for AML that has transformed from MDS, the primary disease for HCT must be reported as AML. Disease Classification questions must be completed for both AML and MDS. The myelodysplastic syndromes (MDS) are a…

Q1-4: Recipient Death Data

Comprehensive Baseline & Follow-up Manuals » 2900: Recipient Death » Q1-4: Recipient Death Data

Question 1: Date of Death: Report the date the recipient died. Confirm that the date matches the last date of actual contact reported on the Form 2100 or Form 4100. If the death occurred at an outside location and records of death are not available, the dictated date…

Q177: Clinical Features Just Prior to the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2029/2129: Fanconi Anemia / Constitutional Anemia » 2029: Fanconi Anemia / Constitutional Anemia Pre-HCT » Q177: Clinical Features Just Prior to the Preparative Regimen

Question 177: What was the recipient’s disease status immediately prior to the preparative regimen? The pre-HCT disease status is determined by a disease assessment, such as hematologic testing, pathology study, and / or physician assessment. Indicate the…

2019 Manual Updates

Getting Started » Getting Started » 2019 Manual Updates

January 2019 February 2019 March 2019 April 2019 May 2019 June 2019 July 2019 August 2019 October 2019 December 2019 Updates made during the current calendar year are included below. For updates prior to 2019, click on the subtopic corresponding to the year of…

2030: SCD Pre-Infusion

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion

SCD Pre-Infusion Data The Sickle Cell Disease (SCD) Pre-Infusion Data Form (Form 2030) is one of the Comprehensive Report Forms. This form captures SCD-specific pre-infusion data such as: disease classification at diagnosis, transfusion status prior to the start of…

Appendix O: Cellular Therapy Critical Fields

Appendices » Appendix O: Cellular Therapy Critical Fields

The following list of data fields have been identified as being critical to accurate outcome analyses. These fields are audited for each recipient selected for audit. The table below is a summary of many of the critical data points grouped by data field type. Critical…

2016: PCD Pre-Infusion

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2016: PCD Pre-Infusion

The Plasma Cell Disorder Pre-Infusion Data Form (Form 2016) is one of the Comprehensive Report Forms. This form captures PCD-specific pre-infusion data such as: disease classification at diagnosis, hematologic findings at the time of diagnosis and prior to the start of…

Q1-21: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2013: CLL Pre-Infusion » Q1-21: Disease Assessment at Diagnosis

*Subsequent Infusion If this is a report of a second or subsequent transplant or cellular therapy, check “yes” under the Subsequent Transplant or Cellular Therapy section of the form and continue with question 149. Questions 1-2: What was the date of diagnosis of…

Q59-77: Laboratory Studies at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2119: WM Post-HCT » Q59-77: Laboratory Studies at the Time of Evaluation for this Reporting Period

These questions are intended to determine the status of the recipient at the last evaluation for this reporting period. Testing may have been performed multiple times during the reporting period; report the most recent laboratory values. Reported values should be…

Q1-8: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2031: ID Pre-HCT » Q1-8: Disease Assessment at Diagnosis

Question 1: What was the date of diagnosis of Immune Deficiency (ID)? Immune Deficiencies are characterized by multiple clinical, laboratory, and genetic features. Definitive diagnosis is often based on molecular testing such as detection of mutations in IL-2RG for…

2128: Aplastic Anemia Post-HCT

Comprehensive Disease-Specific Manuals » 2028/2128: Aplastic Anemia » 2128: Aplastic Anemia Post-HCT

The Aplastic Anemia Post-HSCT Data Form is one of the Comprehensive Report Forms. This form captures aplastic anemia-specific post-HSCT disease assessment data for the reporting period. This form must be completed for all recipients whose primary disease, as reported…

Q1-2: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2016: PCD Pre-Infusion » Q1-2: Disease Assessment at Diagnosis

Question 1: Specify the multiple myeloma / plasma cell disorder (PCD) classification: Specify the indication for transplant. This question will be auto-populated from the Pre-TED Disease Classification and Characteristics (2402) Form. See below for characteristics of…

Q2-33: Disease Assessment

Comprehensive Disease-Specific Manuals » 2028/2128: Aplastic Anemia » 2028: Aplastic Anemia Pre-Infusion » Q2-33: Disease Assessment

Question 2: Was a bone marrow examination performed? (at diagnosis) Indicate Yes or No if a bone marrow examination was performed at diagnosis or prior to the first treatment of aplastic anemia. If a bone marrow examination was not performed or it is not known if one…

Q36-82: Organ Function

Infection & Miscellaneous Manuals » 2540: Tepadina® Supplemental Data » Q36-82: Organ Function

Questions 36 – 82: Organ Function This section of the form compliments the organ function section of the Post-HCT Follow Up Data Form, F2100. Hypersensitivity !Questions 36-40 can only be complete on the 100 day follow-up form. These questions will be skipped…

Q101: Disease Status

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion » Q101: Disease Status

Question 101: What is the status of sickle cell disease at the time of this report, or at the time of death? Report the status of the recipient’s sickle cell disease based on the Hb S and clinical symptoms at the time of evaluation, or death, for this reporting…

Q86-103: Additional Drugs Given in the Peri-Transplant Period

Comprehensive Baseline & Follow-up Manuals » 2000: Recipient Baseline » Q86-103: Additional Drugs Given in the Peri-Transplant Period

Drugs may be given during the peri-transplant period to prevent transplant-related complications or facilitate engraftment. Question 86: ALG, ALS, ATG, ATS Anti-Lymphocyte Globulin (ALT), Anti-Lymphocyte Serum (ALS), Anti-Thymocyte Globulin (ATG), or Anti-Thymocyte…

Q51-115: Clinical Features Assessed Between Diagnosis and the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2031: ID Pre-HCT » Q51-115: Clinical Features Assessed Between Diagnosis and the Start of the Preparative Regimen

Infection Identified between Diagnosis and the Start of the Preparative Regimen Specify the presence of all clinically significant infections identified between diagnosis and the start of the preparative regimen. Only report an organism once, even if it was identified…

2015 Manual Updates

Getting Started » Getting Started » 2015 Manual Updates

December 2015 September 2015 August 2015 July 2015 June 2015 May 2015 !Hyperlinks Please note, hyperlinks on this page will not work for any manual sections which have been retired and / or replaced by new versions. December 2015 Date Manual Section…

Q44-82: Donor Information

Transplant Essential Data (TED) Manuals » 2400: Pre-TED » Q44-82: Donor Information

Question 44: Multiple donors? Indicate if cells from multiple different donors (multiple CBUs, combinations of other products from different donors) are to be used for this HCT. If Yes, continue with question 45. If No, continue with question 46. For example,…

Q1-2: Primary Disease for HCT / Cellular Therapy

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q1-2: Primary Disease for HCT / Cellular Therapy

*Disease Classification Questions The newest versions of the TED Forms use the World Health Organization (WHO) disease classifications. The Disease Classification questions contain all of the established WHO disease types and subtypes. The “other, specify” category…

2116: PCD Post-Infusion

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2116: PCD Post-Infusion

The Plasma Cell Disorder Post-HCT Data Form is one of the Comprehensive Report Forms. This form captures plasma cell disorder (PCD) post-HCT data such as: disease assessment at the time of best response, hematologic and organ parameters at the time of best response,…

Q14-41: Laboratory Studies at Diagnosis

Comprehensive Disease-Specific Manuals » 2033/2133: Wiskott-Aldrich Syndome (WAS) » 2033: WAS Pre-HCT » Q14-41: Laboratory Studies at Diagnosis

Report findings at the time of diagnosis; if multiple studies were performed prior to the institution of therapy, or if time elapsed between diagnosis and treatment, report the latest values prior to any first treatment of Wiskott-Aldrich syndrome, such as IL-2 therapy…

Q44-46: Pain

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion » Q44-46: Pain

Question 44: Has vaso-occlusive pain occurred requiring hospitalization or treatment? (treatment that is in a hospital or clinic setting since the date of last report) Vaso-occlusive pain, sometimes called a pain crisis, is a common painful complication of sickle cell…

4100: Cellular Therapy Essential Data Follow-Up

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up

This form must be completed for all recipients of cellular therapy (non-HCT), including post-HCT “DCI / DLI” infusions. For recipients of hematopoietic cellular transplants, complete the appropriate HCT follow-up form. The Post-Cellular Therapy Essential Data…

Q12-20: Peripheral Blood Count Recovery

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q12-20: Peripheral Blood Count Recovery

!Questions 12 – 15 can only be completed on the 100 day and 6 month follow-up forms. These questions will be disabled for all subsequent reporting periods. Combined follow up In scenarios where an HCT was given after a cellular therapy and this form is now being…

Q428-440: Infection

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q428-440: Infection

Infections occur frequently in transplant patients. Questions 428-440 are intended to capture detailed information on clinically significant infections diagnosed during the reporting period. A single infection may be found on multiple cultures or at multiple sites.…

Q372-378: Other Leukemia

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q372-378: Other Leukemia

CLL, or chronic lymphocytic leukemia, is characterized by ≥ 5 × 109/L monoclonal lymphocytes with a CLL phenotype (usually co-expressed CD5 and CD23). The term SLL, or small lymphocytic lymphoma is used for non-leukemic cases with the tissue morphology and…

Q1-6: Functional Status

Cellular Therapy Manuals » 3501: Pregnancy Form » Q1-6: Functional Status

!If the female recipient or the male recipient’s female partner is pregnant at the time of submitting this form (created on-demand) or is pregnant on the reported contact date for the current reporting period (created as a result of reporting a pregnancy on the…

Q1-28: Diagnosis

Infection & Miscellaneous Manuals » 2553: VOD/SOS » Q1-28: Diagnosis

Veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) may occur have HCT as a conditioning regimen injury to the hepatic venous endothelium, resulting in hepatic venous outflow obstruction due to occlusion of the hepatic venules and sinusoids. This…

Q1-23: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2034: XLP Pre-HCT » Q1-23: Disease Assessment at Diagnosis

Question 1: Is this recipient a registered participant in the United States Immunodeficiency Network (USIDNET)? The United Stated Immunodeficiency Network (USIDNET) is a research consortium studying primary immune deficiencies. They maintain a registry of primary…

Appendix J: Reporting Comorbidities

Appendices » Appendix J: Reporting Comorbidities

CIBMTR collects comorbidities data based on criteria from the Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI), which was developed and validated by investigators at the Fred Hutchinson Cancer Research Center in Seattle, Washington. The HCT-CI was…

Q7-48: Laboratory Values at Diagnosis

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » 2015: JMML Pre-HCT » Q7-48: Laboratory Values at Diagnosis

Report findings at the time of diagnosis; if multiple studies were performed prior to the institution of therapy, report the latest values prior to first therapy. Questions 7-8: WBC Indicate whether the white blood count (WBC) was “known” or “unknown” at the…

Q7-13: Subsequent Transplant

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q7-13: Subsequent Transplant

Question 7: Did the recipient receive a subsequent HCT since the date of last report? Indicate whether the recipient received a second (or third, etc.) hematopoietic stem cell infusion. Hematopoietic stem cells are defined as mobilized peripheral blood stem cells,…

2006: Hematopoietic Stem Cell Transplant (HCT) Infusion

Comprehensive Baseline & Follow-up Manuals » 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion

Centers must complete the Form 2006 for each product when the recipient is assigned to the Comprehensive Report Form track. Centers must also complete the Form 2006 for the following product types when the recipient is assigned to the Transplant Essential Data…

Appendix B: Glossary of Terms

Appendices » Appendix B: Glossary of Terms

General Terms absolute neutrophil count (ANC) Neutrophils are a type of white blood cell that helps protect the body from infection. The number of neutrophils in a recipient’s blood is used to track recovery after chemotherapy or HSCT. In some types of HSCT, the…

Q3-95: Acute Myelogenous Leukemia

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q3-95: Acute Myelogenous Leukemia

Acute Myelogenous Leukemia (AML) is a cancer of the white blood cells. It is characterized by the rapid proliferation of abnormal, immature myelocytes, known as myeloblasts, in the bone marrow. This accumulation of blasts in the marrow prevents the formation of healthy…

Q96-163: Acute Lymphoblastic Leukemia

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q96-163: Acute Lymphoblastic Leukemia

!Acute Lymphoblastic Lymphoma Due to the aggressive nature of precursor T- and precursor B-cell lymphoblastic lymphoma (or lymphoma / leukemia), the primary disease reported for recipients with these malignancies should be acute lymphoblastic leukemia (T-cell…

Q234-406: Chronic Graft vs. Host Disease (GVHD)

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q234-406: Chronic Graft vs. Host Disease (GVHD)

*Autologous Transplants If this was an autologous HCT, continue with the Infection Prophylaxis section of the form starting with question 407. Chimerism testing and graft-versus-host disease sections should only be completed for allogeneic HCTs. Report any chronic…

Q1-13: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2010: AML Pre-Infusion » Q1-13: Disease Assessment at Diagnosis

Question 1: Is the disease (AML) therapy related? (not MDS / MPN) Agents such as radiation or systemic therapy used to treat other diseases (e.g., Hodgkin lymphoma, non-Hodgkin lymphoma, and breast cancer) can damage the marrow and lead to a secondary malignancy such…

Q397-443: Multiple Myeloma / Plasma Cell Disorder

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q397-443: Multiple Myeloma / Plasma Cell Disorder

One kind of white blood cell, the plasma cell (also called plasma B cells, plasmocytes, or effector B cells), produces proteins called antibodies or immunoglobulins (Igs) that are part of our defense system against foreign substances (called antigens). Antibodies are…

Q103-113: Comorbid Conditions

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion » Q103-113: Comorbid Conditions

*Diagnosis of COVD-19 after the start of the lymphodepleting therapy: Questions 103 – 105 are intended to capture COVID-19 (SARS-CoV-2) infections diagnosed prior to the start of the lymphodepleting therapy / infusion. If a COVID-19 infection is diagnosed after the…

Appendix C: Cytogenetic Assessments

Appendices » Appendix C: Cytogenetic Assessments

Introduction to Chromosomes Cytogenetic Assessment Methods Chimerism and Disease Assessment Introduction to Chromosomes A basic knowledge of chromosome abbreviations / terms is required to interpret cytogenetic test results. Typical human cells contain 23 chromosome…

2017 Manual Updates

Getting Started » Getting Started » 2017 Manual Updates

December 2017 November 2017 October 2017 September 2017 August 2017 July 2017 June 2017 May 2017 April 2017 March 2017 February 2017 January 2017 !Hyperlinks Please note, hyperlinks on this page will not work for any manual sections which have been retired and / or…

Q2-17: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2014: Myelodyplastic Syndrome (MDS) Pre-Infusion » Q2-17: Disease Assessment at Diagnosis

!Questions 2-7 refer to recipients with therapy related MDS. If the diagnosis was other than therapy related MDS continue with question 8. Copy questions 2-7 to report more than one prior disease. Questions 2-3: Specify prior disease Agents such as radiation or…

Q121-150: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2019: WM Pre-HCT » Q121-150: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen

These questions are intended to determine the status of the recipient prior to the preparative regimen. Testing may be performed multiple times within the pre-transplant workup period (approximately 30 days) prior to the start of the preparative regimen; report the…

2010: AML Pre-Infusion

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2010: AML Pre-Infusion

The Acute Myelogenous Leukemia Pre-Infusion Data Form (Form 2010) is one of the Comprehensive Report Forms. This form captures AML-specific pre-infusion data such as: the recipient’s hematologic findings at the time of diagnosis and prior to the start of the…

Q1-6: Survival

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q1-6: Survival

The date of actual contact with the recipient to determine medical status for this follow-up report is based on a medical evaluation conducted by a clinician with responsibility for the recipient’s care. Report the date of the medical evaluation performed closest to…

Q82-139: Disease Assessment at Transformation

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2018: LYM Pre-Infusion » Q82-139: Disease Assessment at Transformation

Question 82: Is the lymphoma histology reported at diagnosis a transformation from CLL? CLL may evolve to a more aggressive diffuse large B-cell lymphoma (DLBCL). This is commonly referred to as Richter’s syndrome or Richter’s transformation. Note, CLL may also…

2018 Manual Updates

Getting Started » Getting Started » 2018 Manual Updates

December 2018 November 2018 October 2018 September 2018 August 2018 July 2018 June 2018 May 2018 April 2018 March 2018 February 2018 January 2018 Updates made during the current calendar year are included below. For updates prior to 2018, click on the subtopic…

Q194-208: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2014: Myelodyplastic Syndrome (MDS) Pre-Infusion » Q194-208: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen

Question 194: Specify transfusion dependence at last evaluation prior to the start of the preparative regimen / infusion: Indicate the transfusion dependence for the recipient at the time last evaluation prior to the start of the preparative regimen / infusion and…