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Q13-15: Collection Procedure

Cellular Therapy Manuals » 4003: Cellular Therapy Product » Q13-15: Collection Procedure

This section applies to Autologous products only. If this was an allogeneic product, continue with the “Cell Product Manipulation” section. Question 13-14: Specify the method of product collection: Specify how the product was collected: Bone marrow aspirate: a…

Q13 -29: Product Processing / Manipulation

Gene Therapy Manuals » 2003: Gene Therapy Product » Q13 -29: Product Processing / Manipulation

Questions 13 – 16: Where was the gene therapy product manufactured / processed? Indicate the location where the gene therapy product was manufactured / processed. Cell processing laboratory at the same center as the product is being infused: The gene therapy…

Q13-16: Megakaryopoiesis / Platelet Recovery

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up » Q13-16: Megakaryopoiesis / Platelet Recovery

!The megakaryopoiesis / platelet recovery section 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. The following questions refer to initial platelet recovery…

Q13 – 24: Post-Transplant Lymphoproliferative Disorder

Infection & Miscellaneous Manuals » 3500: Subsequent Neoplasms » Q13 – 24: Post-Transplant Lymphoproliferative Disorder

!The post-transplant lymphoproliferative disorder questions are only enabled if it is reported Yes, PTLD was diagnosed in the previous section. Question 13: Was PTLD confirmed by biopsy? Indicate Yes or No if PTLD was confirmed by a biopsy. If No, continue with…

Q6-18: Transfusion Therapy

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q6-18: Transfusion Therapy

Question 6: Were any red blood cell (RBC) transfusions administered? Red blood cell (RBC) transfusions are often given as supportive care to lower hemoglobin S for recipients diagnosed with Sickle Cell Disease (SCD). If the recipient received any RBC transfusions…

Q17 – 18: Initial Platelet Recovery

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q17 – 18: Initial Platelet Recovery

!Initial Platelet Recovery The Initial Platelet Recovery section 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. Optional for Non-U.S. Centers The following…

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…

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…

2003: Gene Therapy Product

Gene Therapy Manuals » 2003: Gene Therapy Product

This form must be completed for all products for Gene Therapy recipients. All patients receiving a Gene Therapy product will be placed into the CRF track. For TED only reporting centers, Form 2003 will also need to be completed. The Gene Therapy Product (2003)…

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…

4003: Cellular Therapy Product

Cellular Therapy Manuals » 4003: Cellular Therapy Product

This form must be completed for all products for recipients of non-HCT cellular therapy (including post-HCT “DCI / DLI” infusions). For recipients of hematopoietic cellular transplants (HCT), complete the Hematopoietic Stem Cell Transplant (HCT) Infusion (2006)…

3500: Subsequent Neoplasms

Infection & Miscellaneous Manuals » 3500: Subsequent Neoplasms

The Subsequent Neoplasms (3500) form must be completed when a new malignancy is reported on a Post-HCT Follow-Up (2100) or Cellular Therapy Essential Data Follow-Up Form (4100) form. Reported new malignancies should be different than the disease / disorder for which…

Q2-3: Survival

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q2-3: Survival

Question 2: Date of actual contact with the recipient to determine medical status for this follow-up report: Enter the date of actual contact with the recipient to evaluate medical status for this follow up report. In general, the date of contact closest to the…

2018 Manual Updates

Getting Started » Historical Manual Updates » 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…

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…

Q104-117: Socioeconomic Information

Comprehensive Baseline & Follow-up Manuals » 2000: Recipient Baseline » Q104-117: Socioeconomic Information

Question 104: Is the recipient an adult (18 years of age of older) or emancipated minor? Indicate if the recipient is 18 years of age or older, or if under 18, has been declared an emancipated minor by law. An emancipated minor is a child who has been granted the…

2100: Post-Infusion Follow-Up

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion 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…

2150: Viral Infection Diagnosis and Treatment Form

Infection & Miscellaneous Manuals » 2150: Viral Infection Diagnosis and Treatment Form

The CMV / EBV / ADV / HHV-6 / BK Viral Infection Diagnostic Form captures information regarding the diagnosis, treatment, and status of the following infections: Cytomegalovirus (CMV) Epstein-Barr Virus (EBV) Adenovirus (ADV) Human Herpes Virus 6 (HHV-6) BK Virus…

2542: Mogamulizumab Supplemental Data Collection

Infection & Miscellaneous Manuals » 2542: Mogamulizumab Supplemental Data Collection

The Mogamulizumab Supplemental Data Collection Form (Form 2542) is designed to support a retrospective and prospective, multicenter, observational registry of patients treated with mogamulizumab alone or in combination, within one year prior to allogeneic hematopoietic…

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…

Q47-51: Renal Assessments

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q47-51: Renal Assessments

Questions 47 – 48: Urine albumin Indicate whether urine albumin was measured prior to the start of the preparative regimen / infusion. If measured, select Known and report the laboratory value and unit of measure documented on the laboratory report. If urine albumin…

2110: AML Post-Infusion

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

The Acute Myelogenous Leukemia Post-Infusion Data Form (Form 2110) is one of the Comprehensive Report Forms. This form captures AML-specific post-infusion data such as: the recipient’s best response to HCT or cellular therapy, cytogenetic and molecular findings at…

2111: ALL Post-Infusion

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2111: ALL Post-Infusion

The Acute Lymphoblastic Leukemia Post-Infusion Data Form (Form 2111) is one of the Comprehensive Report Forms. This form captures ALL-specific post-infusion data such as: the recipient’s best response to HCT or cellular therapy, cytogenetic and molecular findings at…

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…

Q11-19: Post-HCT Therapy

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » 2115: JMML Post HCT » Q11-19: Post-HCT Therapy

Question 11: Was any therapy given for relapsed, persistent, or progressive disease since the date of last report? Indicate if the recipient received treatment for relapsed JMML during the current reporting period. Do not report therapy given for maintenance (to…

Q31-37: Renal Assessments

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion » Q31-37: Renal Assessments

Question 31: Were renal assessments conducted? Indicate if urine albumin, serum creatinine, or GFR assessments were conducted at the time of evaluation for this reporting period. If these renal assessments were performed, report Yes. If these renal assessments were…

ALL Response Criteria

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » ALL Response Criteria

Complete Remission (CR) Hematologic complete remission is defined as meeting all of the following response criteria for at least four weeks. < 5% blasts in the bone marrow Normal maturation of all cellular components in the bone marrow No extramedullary disease…

2157: Myeloproliferative Neoplasm (MPN) Post-Infusion

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2157: Myeloproliferative Neoplasm (MPN) Post-Infusion

This form must be completed for all recipients who are randomized to the Comprehensive Report Form (CRF) track and whose primary disease is reported on the Pre-TED Disease Classification Form (Form 2402) as “Myeloproliferative Neoplasm (MPN) (1460)”. The…

Q71-77: Transfusion Status from Diagnosis to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2028/2128: Aplastic Anemia » 2028: Aplastic Anemia Pre-Infusion » Q71-77: Transfusion Status from Diagnosis to the Start of the Preparative Regimen / Infusion

Question 71: Were red blood cell transfusions received? Red blood cell (RBC) transfusions are often given as supportive care to re-establish baseline hemoglobin counts for recipients diagnosed with aplastic anemia. If the recipient received any RBC transfusions…

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…

Q1 – 23: Recipient Information

Transplant Essential Data (TED) Manuals » 2400: Pre-TED » Q1 – 23: Recipient Information

Question 1: Date of Birth The date of birth is automatically populated based on the value reported in the CRID Assignment tool in FormsNet3. Verify that the date of birth is correct. If an error is noted, correct the CRID Assignment tool and verify that the date of…

2146: Fungal Infection Post-Infusion Data

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2146: Fungal Infection Post-Infusion Data

The Fungal Infection Post-Infusion Data Form (Form 2146) captures information regarding the diagnosis, treatment, and response to treatment of fungal infections diagnosed after receiving a HCT or cellular therapy. This form must be completed when one of the fungal…

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…

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,…

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…

Q1-19: 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…

Q2-24: HLA Typing by DNA Technology

Comprehensive Baseline & Follow-up Manuals » 2005: Confirmation of HLA Typing » Q2-24: HLA Typing by DNA Technology

Complete this section for all typing done by DNA based methods. Examples of HLA typing by DNA technology may include: sequence-specific primer (SSP), sequence-specific oligonucleotide probe (SSOP), and sequence-based typing (SBT). DNA technology can be used to type…

2115: JMML Post HCT

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » 2115: JMML 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 Myelodysplastic (MDS)/myeloproliferative (MPN) diseases and question 480…

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…

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…

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. The graft-versus-host disease section should only be completed for allogeneic HCTs. Graft versus Host Disease (GVHD) is an immunological phenomenon…

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…

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…

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…

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…

2565: Sanofi Mozobil Supplemental Data

Infection & Miscellaneous Manuals » 2565: Sanofi Mozobil Supplemental Data

The Sanofi Mozobil Supplemental Data Collection Form (Form 2656) is designed to support a prospective, multicenter, observational registry of myeloma recipients undergoing hematopoietic progenitor cell mobilization and peripheral blood stem cell collection for upfront…

2112: CML Post-Infusion Data

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

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.…

2119: WM Post-HCT

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2119: WM 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 Non-Hodgkin lymphoma and the subtype is reported as Waldenström’s…

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…

2113: CLL Post-Infusion

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

The Chronic Lymphocytic Leukemia Post-Infusion Data Form is one of the Comprehensive Report Forms. This form captures CLL-specific post-infusion data such as: disease assessment at the time of best response to HCT or cellular therapy, laboratory studies at the time of…

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…

Q9-50: Laboratory Studies at Diagnosis

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2031: ID Pre-HCT » Q9-50: Laboratory Studies at Diagnosis

Report findings prior to any first treatment of the immune deficiency for which the HCT is being performed. Question 9: Date CBC tested Report the date of CBC testing done within 6 weeks of diagnosis. Continue with question 10. Question 10: WBC Report the white…

Q6-12: Granulopoiesis / Neutrophil Recovery

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up » Q6-12: Granulopoiesis / Neutrophil Recovery

!This section 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. Absolute neutrophil recovery (ANC) recovery is defined as an ANC of ≥ 500/mm3 (or ≥ 0.5 ×…

Q1-43: Laboratory Studies Post-HCT

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2131: ID Post-HCT » Q1-43: Laboratory Studies Post-HCT

To be completed in conjunction with a form 2100 – 100 Days Post-HCT Data, 2200 – Six Months to Two Years Post-HCT Data, or Form 2300 – Yearly Follow-Up for Greater than Two Years Post-HCT Data. Information reported here should reflect the date of last contact as…

2118: LYM Post-Infusion

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2118: LYM Post-Infusion

Complete this form for recipients whose primary disease, reported on the Disease Classification Form (Form 2402), is Hodgkin Lymphoma (HL) or non-Hodgkin Lymphoma (NHL). One exception is Waldenstrom’s macroglobulinemia / lymphoplasmacytic lymphoma, for which, a…

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…

Q1-25: 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…

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…

Q1-50: Laboratory Studies Post-HCT

Comprehensive Disease-Specific Manuals » 2033/2133: Wiskott-Aldrich Syndome (WAS) » 2133: WAS Post-HCT » Q1-50: Laboratory Studies Post-HCT

Report the most recent findings since the date of the last report. For questions 1-3 and 6-7, also report CBC results in the Form 2100 – 100 Days Post-HCT Data, or in the Form 2200 – Six Months to Two Years Post-HCT Data. Question 1: Date of most recent…

2019 Manual Updates

Getting Started » Historical Manual Updates » 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…

2020 Manual Updates

Getting Started » Historical Manual Updates » 2020 Manual Updates

January 2020 February 2020 March 2020 April 2020 May 2020 June 2020 July 2020 August 2020 October 2020 December 2020 Updates made during the current calendar year are included below. For updates prior to 2020, click on the subtopic corresponding to the year of…

2450: Post-TED

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

Transplant centers participating in the CIBMTR must submit a Post-TED Form for recipients who meet any of the following criteria: Recipient receives a transplant at a United States center designated as a TED-only center. Recipient receives a transplant at a United…

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…

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…

Q81 – 130: Acute Graft vs. Host Disease (GVHD)

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up » Q81 – 130: Acute Graft vs. Host Disease (GVHD)

*Autologous Transplants If this was an autologous infusion or syngeneic, continue with the Infection Prophylaxis section. The graft-versus-host disease sections should only be completed if an allogeneic donor was used. !Acute GVHD Prophylaxis Acute GVHD prophylaxis…

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,…

Q7-26: History of Antiviral Therapy for Hepatitis – Recipient

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2047: Hepatitis Serology Pre-HCT » Q7-26: History of Antiviral Therapy for Hepatitis – Recipient

Question 7: Did the recipient receive therapy for hepatitis prior to HCT? Hepatitis antiviral therapy is intended to prevent progression of the disease and minimize sequelae of infection. The National Institutes of Health (NIH) in the United States recommends…

Q18-37: Antiviral Therapy for Hepatitis

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2147: Hepatitis Serology Post-HCT » Q18-37: Antiviral Therapy for Hepatitis

This section is related to antiviral therapy given to the recipient. Question 18: Was therapy given for hepatitis since the date of the last report (or, if this is the first post-HCT report, since diagnosis)? Hepatitis antiviral therapy is intended to prevent…

Lymphoma Response Criteria

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » Lymphoma Response Criteria

*Reporting Lymphoma Disease Status on TED Forms When reporting the disease status on the TED forms (Disease Classification (2402) and Post-TED (2450) forms), report the disease status using the metabolic (PET) criteria. If it is not possible to use the metabolic…

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,…

Q14 – 16: Initial ANC Recovery

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

!Initial ANC Recovery The Initial ANC Recovery questions 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…

Q8-21: Product Transport and Receipt

Comprehensive Baseline & Follow-up Manuals » 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion » Q8-21: Product Transport and Receipt

Question 8: Was this product collected off-site and shipped to your facility? If the product was shipped to the transplant center or contracted lab from an off-site collection center, select “yes.” In general, the “yes” option will be used for unrelated…

Q18-58: Post-HCT Therapy

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2119: WM Post-HCT » Q18-58: Post-HCT Therapy

Complete a “Line of Therapy” section for each line of therapy administered during the current reporting period. If multiple lines of therapy were administered, copy and complete questions 19-56 for each line of therapy. Question 18: Was therapy given since the…

Amyloidosis Response Criteria

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » Amyloidosis Response Criteria

Hematologic Response Complete Response Requires all of the following: Serum and urine negative for monoclonal proteins by immunofixation Normal serum free light chain ratio Very Good Partial Response Reduction in the difference between the involved and…

2046: Fungal Infection Pre-Infusion Data

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2046: Fungal Infection Pre-Infusion Data

Fungal infections are significant opportunistic infections affecting transplant patients. Because these infections are quite serious, it is important to collect additional information on them. The Fungal Infection Pre-Infusion Data Form (Form 2046) captures…

Q18-83: Laboratory Studies at Diagnosis

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2012: CML Pre-Infusion Data » Q18-83: Laboratory Studies at Diagnosis

All values reported in questions 18-83 must reflect testing performed prior to any treatment of CML. If testing was not performed near the time of diagnosis and prior to the initiation of treatment, report unknown for that value. If the exact date of sample…

Q451-487: Hemoglobinopathies

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q451-487: Hemoglobinopathies

Questions 451 – 453: Specify the hemoglobinopathy classification Indicate the hemoglobinopathy classification of the primary disease for infusion. Sickle cell disease: A group of disorders that adversely affect the body’s production of hemoglobin, the component…

2011: ALL Pre-Infusion

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2011: ALL Pre-Infusion

The Acute Lymphoblastic Leukemia Pre-Infusion Data Form (Form 2011) is one of the Comprehensive Report Forms. This form captures ALL-specific pre-infusion data such as: the recipient’s hematologic findings at the time of diagnosis and prior to the start of the…

Q10-17: Serological Evidence of Hepatitis Exposure / Infection – Donor

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2147: Hepatitis Serology Post-HCT » Q10-17: Serological Evidence of Hepatitis Exposure / Infection – Donor

Complete questions 10-17 for allogeneic transplants only; if donor information is unknown, leave the data field blank. These data fields should be used to report new information available for donors that developed hepatitis post-transplant. If this is the first…

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…

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…

Q18-32: Cellular Therapy and HCT History

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion » Q18-32: Cellular Therapy and HCT History

Question 18: Is this the first time the recipient is being treated using a cellular therapy (non-HCT)? This is defined as the first application of a cellular therapy the recipient ever receives, not the first application the recipient receives at your facility. The…

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…

Q1-9: Serological Evidence of Hepatitis Exposure / Infection – Recipient

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2147: Hepatitis Serology Post-HCT » Q1-9: Serological Evidence of Hepatitis Exposure / Infection – Recipient

Question 1: Hepatitis B core antibody (HBcAb) The total hepatitis B core antibody refers to both IgG and IgM antibodies produced by the body in response to the presentation of the core antigen by liver cells. Since core antigen is present only in infected liver cells…

Q1-17: Recipient Data

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion » Q1-17: Recipient Data

Question 1: Ethnicity The recipient’s ethnicity is automatically populated based on the value reported in the CRID assignment tool in FormsNet3. Verify the recipient’s ethnicity is correct. If an error is noted, correct the error in the CRID assignment tool and…

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…

Multiple Myeloma Response Criteria

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » Multiple Myeloma Response Criteria

General Reporting Guidelines Use the multiple myeloma response criteria when determining the disease status for multiple myeloma and solitary plasmacytoma. Immunofixation (IFE) and immunoelectrophoresis (IEP) are essentially measuring the same thing and either may…

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…

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…

Q2 – 22: Leukodystrophy Diagnosis

Comprehensive Disease-Specific Manuals » 2037 / 2137 Leukodystrophies » 2037: Leukodystrophies Pre-Infusion » Q2 – 22: Leukodystrophy Diagnosis

!Hereditary diffuse leukoencephalopathy (HDLS): If the primary disease for infusion is HDLS, manually select this option from question 2. This option will not auto populate at this time. Question 2: Specify the leukodystrophy subtype Indicate the recipient’s…

AML Response Criteria

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

*For recipients with MDS / MPN / MF that transformed to AML Historically, for recipients who had residual MDS / MPN / MF following treatment for AML, the AML disease status was reported as either PIF or relapse (i.e., the recipient cannot be in an AML CR if there is…

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:…

Q16-37: Cell Product Manipulation

Cellular Therapy Manuals » 4003: Cellular Therapy Product » Q16-37: Cell Product Manipulation

*This section applies only to products that are not commercially available. If a commercially available product (e.g., Kymriah®, Yescarta®, TecartusTM, BreyanziTM, Abecma®) or pre-commercial product was selected in question one, continue to question 38. *This…

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,…

Q1-31: Product Identification

Cellular Therapy Manuals » 4006: Cellular Therapy Infusion » Q1-31: Product Identification

Question 1: Name of product: *If your center considers this to be a Donor Lymphocyte Infusions (DLI), as reported on the Pre-CTED (4000) form, product name will not be auto-populated. Select Other product for the product name. The name of the product reported will…

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…

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…

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…

2016 Manual Updates

Getting Started » Historical Manual Updates » 2016 Manual Updates

December 2016 August 2016 July 2016 June 2016 April 2016 March 2016 February 2016 January 2016 !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 2016 Date…

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…