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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…

Q131-233: Acute Graft vs. Host Disease (GVHD)

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q131-233: Acute 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. !Questions 131-156 can…

Q60-79: Graft vs. Host Disease

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q60-79: Graft vs. Host Disease

*Autologous Infusions Questions 60-77 should be completed for allogeneic infusions only. If this was an autologous infusion, continue to the “Toxicities” section. Combined follow up In scenarios where both HCT and cellular therapy forms are being completed, there…

Q19-44: Graft versus Host Disease (Allogeneic Only)

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q19-44: Graft versus Host Disease (Allogeneic Only)

!Autologous Transplants If this was an autologous HCT, continue with the Liver Toxicity Prophylaxis section of the form starting with question 39. The graft-versus-host disease section should only be completed for allogeneic HCTs. Graft versus Host Disease (GVHD) is…

2402: Disease Classification

Transplant Essential Data (TED) Manuals » 2402: Disease Classification

The Disease Classification Form is required for all transplants, including subsequent transplants on the comprehensive report form track and cellular therapy infusions when the indication is malignant hematologic disorder, non-malignant disorder or solid tumor. All…

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…

Q512: Other Disease

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q512: Other Disease

Question 512: Specify other disease: Before using this category, check with a transplant physician to determine whether the disease can be classified as one of the listed options in the Disease Classification questions. An example of another disease is dystrophic…

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…

Q168-178: Chronic Myelogenous Leukemia

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q168-178: Chronic Myelogenous Leukemia

Chronic myelogenous leukemia (CML) is a slow-progressing cancer of the myeloid white blood cells. It is characterized by increased proliferation of immature white blood cells (granulocytes) with damaged DNA, or blasts, which accumulate in the blood and bone marrow.…

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…

Q1-2: Disease Specificity

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2116: PCD Post-Infusion » Q1-2: Disease Specificity

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. Question 2: Specify preceding /…

2004: Infectious Disease Markers

Comprehensive Baseline & Follow-up Manuals » 2004: Infectious Disease Markers

Form 2004 will come due in the following instances: Non-NMDP unrelated donor (TED or CRF track) Non-NMDP unrelated cord blood (TED or CRF track) Related cord blood (TED or CRF track) HLA-identical sibling (CRF track or when consented for “Research Sample…

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.,…

2013/2113: Chronic Lymphocytic Leukemia (CLL)

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

Chronic lymphocytic leukemia (CLL) is a cancer of the B lymphocytes. B lymphocytes are white blood cells that develop in the bone marrow and circulate throughout the blood to fight infection. In CLL, lymphocytes with damaged DNA proliferate within the blood,…

2012/2112: Chronic Myeloid Leukemia (CML)

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML)

Chronic myelogenous leukemia (CML) is a slow-progressing cancer of the myeloid white blood cells. It is characterized by the increased proliferation of immature white blood cells (granulocytes) with damaged DNA, or blasts, which accumulate in the blood and bone marrow.…

Q119-122: Current Disease Status

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q119-122: Current Disease Status

!Malignant Diseases Only Only complete questions 119-122 if the HCT being reported was given to treat a malignant disease. If the HCT being reported was given to treat a non-malignant disease, leave questions 117-120 blank. FormsNet3SM should enable / disable this…

Q2-29: Infectious Disease Markers

Comprehensive Baseline & Follow-up Manuals » 2004: Infectious Disease Markers » Q2-29: Infectious Disease Markers

Report the final test results. Final test results could refer to either the initial screening test or the confirmatory test. If a screening test is negative, a confirmatory test might not be done. In this case, use the screening test as the final test result. However,…

Q67-73: Disease Modifying Therapies

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion » Q67-73: Disease Modifying Therapies

Question 67: Were disease modifying therapies given or stopped since the date of last report? Indicate if the recipient received any disease modifying therapies (see question 68 for a list of common disease modifying therapies) or if the recipient discontinued a…

Q86-92: Disease Modifying Therapies

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q86-92: Disease Modifying Therapies

Question 86: Were disease modifying therapies given? (excludes blood transfusions) Indicate if the recipient received disease modifying therapies (see question 87 for a list of common disease modifying therapies) at any time between diagnosis and the start of the…

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…

Q1-55: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2018: LYM Pre-Infusion » Q1-55: Disease Assessment at Diagnosis

Question 1-2: Specify the lymphoma histology (at diagnosis) *Double-hit or triple-hit lymphomas – Rearrangements of MYC and BCL2 and/or BCL6 constitute a single category in the updated WHO classification and should be reported as “High-grade B-cell lymphoma,…

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…

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…

Q1-22: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2039/2139: Hemophagocytic Lymphohistiocytosis (HLH) » 2039: HLH Pre-HCT » Q1-22: 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…

Q1-2: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2019: WM Pre-HCT » Q1-2: Disease Assessment at Diagnosis

Question 1: What is the diagnosis? Waldenström’s macroglobulinemia (WM) and lymphoplasmacytic lymphoma (LPL) are two closely related neoplasms. They are both characterized by an abnormal population of small B-cells, lymphoplasmacytoid cells, and plasma cells. WM is…

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…

Q1 – 141: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2029/2129: Fanconi Anemia / Constitutional Anemia » 2029: Fanconi Anemia / Constitutional Anemia Pre-HCT » Q1 – 141: Disease Assessment at Diagnosis

Question 1: What was the date of diagnosis of Fanconi Anemia? Report the date of first pathological evaluation (e.g., bone marrow biopsy) or blood/serum assessment (e.g., CBC, peripheral blood smear) that determined the diagnosis of Fanconi anemia. Enter the date the…

Q142 – 176: Familial History of Disease

Comprehensive Disease-Specific Manuals » 2029/2129: Fanconi Anemia / Constitutional Anemia » 2029: Fanconi Anemia / Constitutional Anemia Pre-HCT » Q142 – 176: Familial History of Disease

Questions 142 – 148: Were any other genetically related family members affected? Indicate Yes or No if any other genetically related family members have been diagnosed with Fanconi Anemia. This includes a sibling, cousin, parent, aunt / uncle, or other…

Q2-10: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion » Q2-10: Disease Assessment at Diagnosis

Report findings prior to any first treatment of the primary disease for which the HCT / cellular therapy is being performed. If the recipient’s MPN transformed, report the studies from the original diagnosis. Question 2: Specify transfusion dependence at the time of…

Q2-5: Disease Classification at Diagnosis

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q2-5: Disease Classification at Diagnosis

*Note: When reporting data on the Sickle Cell Disease (SCD) Pre-Infusion Data Form (Form 2030 – Revision 3), report all findings at any time prior to the start of the preparative regimen, unless otherwise specified. If no preparative regimen was given, report all…

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…

Q21-22: Disease Relapse or Progression

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q21-22: Disease Relapse or Progression

*This section is applicable to malignant diseases only and does not apply to commercially available products. Question 21-22: Was a disease relapse or progression detected since the date of last report? Disease relapse or progression can be documented by a variety of…

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…

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…

2030/2130: Sickle Cell Disease (SCD)

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

Sickle Cell Disease (SCD) is a group of disorders that adversely affect the body’s production of hemoglobin, the component in red blood cells that delivers oxygen throughout the body.1 Individuals with these disorders possess atypical hemoglobin molecules, called…

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…

Q1-17: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2012: CML Pre-Infusion Data » Q1-17: Disease Assessment at Diagnosis

Question 1: What was the date of diagnosis? Report the date of the first pathological diagnosis (e.g., bone marrow) of CML. Enter the date the sample was collected for examination. If the diagnosis was determined at an outside center and no documentation of a…

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…

Appendix G: Tracking Disease Status for Multiple Myeloma

Appendices » Appendix G: Tracking Disease Status for Multiple Myeloma

Successfully tracking and reporting disease status for multiple myeloma requires a understanding of the different methods of assessment, away of organizing relevant test results, and the ability to identify the correct baseline against which changes in test results can…

Q34: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q34: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder

!New Malignancies Report new malignancies that are different than the disease / disorder for which cellular therapy was performed. Do not include relapse, progression or transformation of the same disease subtype. New malignancy related questions will now be asked on…

Q1-23: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder

Cellular Therapy Manuals » 3500: Subsequent Neoplasms » Q1-23: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder

*The submission of a pathology report or other supportive documentation for each reported new malignancy is strongly recommended. Questions 1-3: Specify the new malignancy: Indicate which new malignancy / disorder was diagnosed during the reporting period. If the new…

Q48-94: Disease Detection Since Date of Last Report

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2111: ALL Post-Infusion » Q48-94: Disease Detection Since Date of Last Report

!Questions 48-94 This section is intended to capture information only on recipients who relapse, have persistent or minimal residual disease in this reporting period. For questions 48, 54, 61, 71, and 78, report “No” or “Unknown” (see instructions…

Q233 – 271: Disease Status Immediately Prior to Preparative Regimen

Comprehensive Disease-Specific Manuals » 2026/2126: Neuroblastoma » 2026: Neuroblastoma Pre-Infusion » Q233 – 271: Disease Status Immediately Prior to Preparative Regimen

Questions 233 – 248: Were tumor marker analyses performed immediately prior to the preparative regimen? Tumor markers, also known as biomarkers, are substances produced by cancer tissue or by the body in response to cancer at higher than normal levels. In…

Q616-639: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q616-639: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder

Post-Transplant Lymphoproliferative Disorder Instructions section Question 616: Did a new malignancy, myelodysplastic, myeloproliferative, or lymphoproliferative disease / disorder occur that is different from the disease / disorder for which the HCT or cellular…

Q51-103: Disease Detection Since Date of Last Report

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2110: AML Post-Infusion » Q51-103: Disease Detection Since Date of Last Report

!Questions 51-103 This section is intended to capture information only on recipients who relapse, have persistent or minimal residual disease in this reporting period. For questions 51, 63, 70, 80, and 87, report “No” or “Unknown” (see instructions…

Q18-47: Diagnostic Studies (Measured Prior to First Disease Treatment)

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2014: Myelodyplastic Syndrome (MDS) Pre-Infusion » Q18-47: Diagnostic Studies (Measured Prior to First Disease Treatment)

Report findings prior to any first treatment of the primary disease for which the HCT / cellular therapy is being performed. If the recipient’s MDS transformed, report the studies from the original diagnosis. If multiple studies were performed prior to the start of…

Q1-63: Disease Assessment at the Time of Best Response

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2112: CML Post-Infusion Data » Q1-63: Disease Assessment at the Time of Best Response

Question 1: What was the best response to HCT or cellular therapy since the date of the last report? (include response to any therapy given for post-HCT maintenance or consolidation, but exclude any therapy given for relapsed, persistent, or progressive disease) The…

Q4-26: Disease Assessment at the Time of Best Response

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2113: CLL Post-Infusion » Q4-26: Disease Assessment at the Time of Best Response

Question 4-5: Were tests for molecular markers performed (e.g. PCR)? 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…

Q43-88: Disease Relapse or Progression Post-HCT / Post-Infusion

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2113: CLL Post-Infusion » Q43-88: Disease Relapse or Progression Post-HCT / Post-Infusion

Question 43: Was a disease relapse or progression detected since the date of last report? Refer to the international working group criteria provided in CLL Response Criteria section of the Forms Instructions Manual for more information on how to determine recurrence…

Q105-202: Disease Detection Since the Date of Last Report

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2157: Myeloproliferative Neoplasm (MPN) Post-Infusion » Q105-202: Disease Detection Since the Date of Last Report

Questions 105-106: Did the recipient have splenomegaly? Indicate if the recipient had splenomegaly indicative of disease detection since the date of the last report. Splenomegaly is often documented during the physician’s physical assessment of the recipient and…

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…

Q100-109: Disease Relapse or Progression Post-HCT / Post-Infusion

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2112: CML Post-Infusion Data » Q100-109: Disease Relapse or Progression Post-HCT / Post-Infusion

Questions 100-109 are intended to capture the detection of relapse or progression of CML by molecular, cytogenetic, and clinical / hematologic assessments performed during the reporting period. Molecular and cytogenetic detection of relapse / progression should be…

Q1-19: Disease Assessment Since the Date of Last Report

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2134: XLP Post-HCT » Q1-19: Disease Assessment Since the Date of Last Report

Question 1: Did the recipient have lymphoma at the time of HCT? XLP is associated with a higher incidence of lymphoma, which may be secondary to EBV infection; however, not all lymphomas in the setting of XLP exhibit EBV clonality. There is speculation that lymphoma…

Q11-40: Diagnostic Studies (Measured Prior to First Disease Treatment)

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion » Q11-40: Diagnostic Studies (Measured Prior to First Disease Treatment)

Report findings prior to any first treatment of the primary disease for which the HCT / cellular therapy is being performed. If the recipient’s MPN transformed, report the studies from the original diagnosis. If multiple studies were performed prior to the start of…

Q1-32: Disease Assessment Since the Date of Last Report

Comprehensive Disease-Specific Manuals » 2039/2139: Hemophagocytic Lymphohistiocytosis (HLH) » 2139: HLH Post-HCT » Q1-32: Disease Assessment Since the Date of Last Report

Indicate which of the following clinical features and laboratory findings were present on the most recent evaluation since the date of the last report. For values assessed multiple times since the date of the last report, report the most recent results. Question 1:…

Q3-60: Diagnostic Studies (Measured Prior to Any Disease Treatment)

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2016: PCD Pre-Infusion » Q3-60: Diagnostic Studies (Measured Prior to Any Disease Treatment)

For questions 3-60, report values obtained at diagnosis or prior to the first treatment for the plasma cell disorder for which the transplant was performed. If testing is performed multiple times prior to the start of the first treatment, report the last test before…

Q143-145: Post-HCT Disease Therapy Planned as of Day 0

Transplant Essential Data (TED) Manuals » 2400: Pre-TED » Q143-145: Post-HCT Disease Therapy Planned as of Day 0

Question 143: Is additional post-HCT therapy planned? If additional post-HCT therapy is planned according to the protocol or standard of care, check “yes” even if the recipient does not receive the planned therapy. The word “planned” should not be interpreted…

Q1 – 159: Disease Assessments at Time of Best Response to HSCT

Comprehensive Disease-Specific Manuals » 2026/2126: Neuroblastoma » 2126: Neuroblastoma Post-Infusion » Q1 – 159: Disease Assessments at Time of Best Response to HSCT

Question 1: Compared to the disease status prior to the preparative regimen what was the best response since the date of the last report? (Include response to any post-HSCT treatment planned as of day 0) The intent of this question is to determine the best overall…

Q1-17: Disease Assessment at the Time of Best Response to HCT

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2119: WM Post-HCT » Q1-17: Disease Assessment at the Time of Best Response to HCT

Question 1: Compared to the disease status prior to the preparative regimen, what was the best response to HCT since the date of last report? (Include response to any therapy given for post-HCT maintenance or consolidation, but exclude any therapy given for relapsed,…

Q195-198: Disease Status at Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2112: CML Post-Infusion Data » Q195-198: Disease Status at Time of Evaluation for this Reporting Period

Question 195: What was the disease status? Report the recipient’s disease status at the time of evaluation for this reporting period. Ensure the disease status is consistent with the international working group criteria provided in the in CML Response Criteria…

Q1-34: Disease Assessment at the Time of Best Response to HCT

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2111: ALL Post-Infusion » Q1-34: Disease Assessment at the Time of Best Response to HCT

Question 1: What was the best response to HCT or cellular therapy since the date of the last report? (Include response to any therapy given for post-HCT / post-infusion maintenance or consolidation, but exclude any therapy given for relapsed, persistent or progressive…

Q1-3: Disease Assessment at the Time of Best Response to HCT

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » 2115: JMML Post HCT » Q1-3: Disease Assessment at the Time of Best Response to HCT

Question 1: Compared to the disease status prior to the preparative regimen, what was the best response to HCT since the date of the last report? (Include response to any therapy given for post-HCT maintenance or consolidation, but exclude any therapy given for…

Q151-152: Disease Status at Last Evaluation Prior to the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2019: WM Pre-HCT » Q151-152: Disease Status at Last Evaluation Prior to the Preparative Regimen

Question 151: What was the disease status at the last evaluation prior to the preparative regimen? Indicate the disease status of WM or LPL at last evaluation prior to the start of the preparative regimen. See WM Response Criteria for disease status…

Q36-86: Disease Relapse or Progression Since the Date of Last Report

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2118: LYM Post-Infusion » Q36-86: Disease Relapse or Progression Since the Date of Last Report

Question 36: Did the recipient experience a relapse or progression since the date of the last report? (by any method) Relapse / progression may be detected by imaging assessments (CT, PET, MRI) as well as molecular, cytogenetic, and clinical / hematologic methods.…

Q80-102: Disease Assessment at the Time of Best Response to HCT

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q80-102: Disease Assessment at the Time of Best Response to HCT

!Malignant Diseases Only Only complete questions 80-102 if the HCT being reported was given to treat a malignant disease. If the HCT being reported was given to treat a non-malignant disease, leave questions 80-102 blank. FormsNet3SM should enable / disable this…

Q48-58: Disease Assessment Between Diagnosis and the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2039/2139: Hemophagocytic Lymphohistiocytosis (HLH) » 2039: HLH Pre-HCT » Q48-58: Disease Assessment Between Diagnosis and the Start of the Preparative Regimen

Question 48: Were central nervous system (CNS) abnormalities found on computed topography (CT or CAT) or magnetic resonance imaging (MRI) scans? Indicate if radiology (CT, CAT, and/or MRI) performed on the recipient between diagnosis and the start of the preparative…

Q87-90: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2118: LYM Post-Infusion » Q87-90: Disease Status at the Time of Evaluation for this Reporting Period

Question 87: What is the current disease status? (by CT (radiographic) criteria) Indicate the current disease status, based on radiographic criteria, using the international working group criteria provided in LYM Response Criteria section of the Forms Instruction…

Q78-79: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2119: WM Post-HCT » Q78-79: Disease Status at the Time of Evaluation for this Reporting Period

Question 78: What is the current disease status? Indicate the disease status of WM or LPL at last evaluation during the reporting period. See WM Response Criteria for disease status definitions. The center does not need to repeat all disease-specific assessments…

Q203-287: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2157: Myeloproliferative Neoplasm (MPN) Post-Infusion » Q203-287: Disease Status at the Time of Evaluation for this Reporting Period

Question 203: Does the current disease status reflect the disease detected in this reporting period section (as captured in questions 105-202), without subsequent therapy? This section of the form is intended to capture the most recent disease assessments performed in…

Q211-252: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2116: PCD Post-Infusion » Q211-252: Disease Status at the Time of Evaluation for this Reporting Period

For questions 211-252, report values obtained at the last evaluation for this reporting period. If testing is performed multiple times during the reporting period, report the values obtained at the last evaluation in the reporting period. Questions 211-212: Serum…

Q89-113: Disease Status at the Time of Evaluation for This Reporting Period

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2113: CLL Post-Infusion » Q89-113: Disease Status at the Time of Evaluation for This Reporting Period

Question 89-90: Were tests for molecular markers performed (e.g. PCR)? If testing for molecular markers was performed during the reporting period, report “yes” and report the sample collection date of the most recent testing performed during the reporting period…

Q21-22: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » 2115: JMML Post HCT » Q21-22: Disease Status at the Time of Evaluation for this Reporting Period

Question 21: What was the disease status? Indicate the disease status of JMML as of the last evaluation during the reporting period. See JMML Response Criteria for disease status definitions. The center does not need to repeat all disease-specific assessments…

Q52-104: Disease Assessment between Diagnosis and the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2034: XLP Pre-HCT » Q52-104: Disease Assessment between Diagnosis and the Start of the Preparative Regimen

Question 52: Was HLH present? HLH is an abnormal proliferation of macrophages and histiocytes that leads to the phagocytosis of healthy circulating blood cells. Indicate if the patient developed HLH at any time after diagnosis but prior to the start of the preparative…

Q104-144: Disease Status at the Time of Evaluation for This Reporting Period

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2110: AML Post-Infusion » Q104-144: Disease Status at the Time of Evaluation for This Reporting Period

Question 104: Does the current disease status reflect the disease detected in this reporting period section (as captured in questions 51-89), without subsequent therapy? This section of the form is intended to capture the most recent disease assessment. The most…

Q172-236: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2114: Myelodysplastic Syndrome (MDS) Post-Infusion » Q172-236: Disease Status at the Time of Evaluation for this Reporting Period

Question 172: Does the current disease status reflect the disease detected in this reporting period section (as captured in questions 89-152), without subsequent therapy? This section of the form is intended to capture the most recent disease assessments performed in…

Q95-130: Disease Status at the Time of Evaluation for This Reporting Period

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2111: ALL Post-Infusion » Q95-130: Disease Status at the Time of Evaluation for This Reporting Period

Question 95: Does the current disease status reflect the disease detected in this reporting period section (as captured in questions 48-80), without subsequent therapy? This section of the form is intended to capture the most recent disease assessment. The most recent…

Q1-25: Disease Assessment at the Time of Assessment for This Reporting Period

Comprehensive Disease-Specific Manuals » 2028/2128: Aplastic Anemia » 2128: Aplastic Anemia Post-HCT » Q1-25: Disease Assessment at the Time of Assessment for This Reporting Period

Questions 1 – 2: Was the recipient red blood cell (RBC) transfusion independent for the entire reporting period? Indicate if the recipient was RBC transfusion independent for the entire reporting period. Some discretion may be required if the recipient received a…

Q255-261: Disease Assessment at the Last Evaluation Prior to the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion » Q255-261: Disease Assessment at the Last Evaluation Prior to the Preparative Regimen / Infusion

Question 255: Did the recipient have evidence of pulmonary hypertension at HCT? Pulmonary hypertension (PH) refers to elevated pulmonary arterial pressure. PH can be due to a primary elevation of pressure in the pulmonary arterial system alone (pulmonary arterial…

Q60-79: Chimerism Studies (Cord Blood Units, Beta Thalassemia, and Sickle Cell Disease Only)

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q60-79: Chimerism Studies (Cord Blood Units, Beta Thalassemia, and Sickle Cell Disease Only)

*This section relates to chimerism studies from allogeneic HCTs using cord blood units, or for allogeneic HCT recipients whose primary disease is beta thalassemia or sickle cell disease only. If this was an autologous HCT, an allogeneic HCT using a bone marrow or PBSC…

Q1-40: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2110: AML Post-Infusion » Q1-40: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Question 1: What was the best response to HCT or cellular therapy since the date of the last report? (Include response to any therapy given for post-HCT / post-infusion maintenance or consolidation, but exclude any therapy given for relapsed, persistent or progressive…

Q1-3: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2113: CLL Post-Infusion » Q1-3: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Question 1: Compared to the disease status prior to the preparative regimen, what was the best response to HCT or cellular therapy since the date of the last report? (Include response to any therapy given for post-HCT maintenance or consolidation, but exclude any…

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…

Q92-93: Disease Status at Last Evaluation Prior to the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » 2015: JMML Pre-HCT » Q92-93: Disease Status at Last Evaluation Prior to the Start of the Preparative Regimen

Question 92: What was the disease status? Indicate the disease status of JMML at the last evaluation prior to the start of the preparative regimen. If the patient’s disease transformed to AML, do not complete questions 92-93 and continue with the signature…

Q1-20: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2118: LYM Post-Infusion » Q1-20: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

!Post-Infusion Therapy Prior versions of the lymphoma post-infusion manuals have instructed centers to stop tracking the best response to HCT or cellular therapy if the recipient began treatment for persistent disease. The current version of the manual instructs…

Q224-233: Disease Assessment at the Failure of the 1st Line of Therapy (DLBCL only)

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2018: LYM Pre-Infusion » Q224-233: Disease Assessment at the Failure of the 1st Line of Therapy (DLBCL only)

Questions 224-233 will only be answered if the primary disease was reported as diffuse large B-cell lymphoma (DLBCL) either at transformation (question 84) or at diagnosis (question 1) if no transformation occurred. This includes the following DLBCL subtypes: cell of…

Q3-53: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2116: PCD Post-Infusion » Q3-53: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Best response is based on response to the HCT and does NOT include response to therapy given for disease relapse or progression post-HCT. If the HCT or cellular therapy was planned as part of initial therapy for a recipient with no disease progression or relapse at…

Q105-130: Disease Status at Last Evaluation Prior to the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2034: XLP Pre-HCT » Q105-130: Disease Status at Last Evaluation Prior to the Start of the Preparative Regimen

Question 105: Specify the status of HLH If the patient previously had HLH at any time during their disease course, specify if it was “active” or “inactive” (quiescent) at the last evaluation prior to the start of the preparative regimen. If the patient never…

Q253-256: Disease Status at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2012: CML Pre-Infusion Data » Q253-256: Disease Status at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Questions 253-256 refer to the most recent assessments performed prior to the start of the preparative regimen (or prior to infusion if no preparative regimen was given). Question 253: What was the disease status? Indicate the disease status using the international…

Q1-72: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2114: Myelodysplastic Syndrome (MDS) Post-Infusion » Q1-72: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Best response is based on response to the HCT or cellular therapy infusion, but does not include response to any therapy given for disease relapse or progression post-HCT or post-cellular therapy. When determining the best response to HCT or cellular therapy infusion,…

Q1-86: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2157: Myeloproliferative Neoplasm (MPN) Post-Infusion » Q1-86: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Best response is based on response to the HCT or cellular therapy infusion, but does not include response to any therapy given for disease relapse or progression post-HCT or post-cellular therapy. When determining the best response to HCT or cellular therapy infusion,…

Q186-191: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2012: CML Pre-Infusion Data » Q186-191: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Questions 186-191 refer to the most recent assessments performed prior to the start of the preparative regimen (or prior to infusion if no preparative regimen was given). Question 186: Specify the spleen size Report the spleen size in centimeters below the left…

Q234-288: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2018: LYM Pre-Infusion » Q234-288: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

All values reported in questions 234-288 must reflect the most recent testing prior to the start of the preparative regimen (or infusion if not preparative regimen was given). Do not report testing performed during a line of therapy reported in questions 167-223. If…

Q149-191: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2013: CLL Pre-Infusion » Q149-191: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Question 149: Did the recipient have known nodal involvement? Refer to Graphic 1 for identification of nodal areas. Nodal involvement may be assessed by a physician palpating lymph nodes, pathology from a lymph node biopsy, or radiological assessment (e.g., PET or CT…

Q192-193: Disease Status at the Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2013: CLL Pre-Infusion » Q192-193: Disease Status at the Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Question 192: What was the disease status at the last evaluation prior to the start of the preparative regimen? *Nodular Partial Response Nodular partial response (nPR) is a listed disease status option on the Pre-TED Form (Form 2400), but not on the CLL Pre- and…

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…

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…

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…

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…

Q19-48: Growth Factor and Cytokine Therapy

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q19-48: Growth Factor and Cytokine Therapy

!Questions 19-48 can only be completed on the 100 day follow-up form. These questions will be skipped for all subsequent reporting periods. Question 19: Did the recipient receive hematopoietic, lymphoid growth factors or cytokines after the start of the preparatory…

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…