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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…

Q22-73: Laboratory Studies at Diagnosis

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2013: CLL Pre-Infusion » Q22-73: Laboratory Studies at Diagnosis

All values reported in questions 22-73 must reflect testing performed prior to any treatment of CLL/SLL/PLL. If testing was not performed near the time of diagnosis and prior to the initiation of treatment, the center should report unknown for that value. An exception…

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…

Q48-81: IPSS-R Prognosis Score

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2014: Myelodyplastic Syndrome (MDS) Pre-Infusion » Q48-81: IPSS-R Prognosis Score

Question 48: Specify the maximum IPSS-R score the patient ever achieved: The revised International Prognostic Scoring System (IPSS), known as the IPSS-R, is based on five variables including blasts in the bone marrow, cytogenetic findings, hemoglobin, absolute…

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…

Q93-119: Other Laboratory Studies

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q93-119: Other Laboratory Studies

Questions 93 – 94: Was hemoglobin electrophoresis performed? Indicate if hemoglobin electrophoresis studies were performed prior to the start of the preparative regimen / infusion. If hemoglobin electrophoresis studies were performed, report Yes and provide the date…

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…

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…

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…

Q1-19: Laboratory Studies at Diagnosis

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2011: ALL Pre-Infusion » Q1-19: Laboratory Studies at Diagnosis

All values reported in questions 1-19 must reflect testing performed prior to any treatment of ALL. If testing was not performed near the time of diagnosis (within approximately 30 days) and prior to the initiation of treatment, the center should report “Unknown”…

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…

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…

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…

Q24-75: Laboratory Studies at Diagnosis

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2019: WM Pre-HCT » Q24-75: Laboratory Studies at Diagnosis

Report findings at the time of diagnosis. If multiple studies were performed prior to beginning therapy, report the latest values prior to the start of treatment. Questions 24-25: Absolute lymphocyte count Indicate whether the lymphocyte count was “known” or…

Q88-171: Most Recent Laboratory Studies

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2114: Myelodysplastic Syndrome (MDS) Post-Infusion » Q88-171: Most Recent Laboratory Studies

!Questions 88-99 refer to overlap syndromes including CMMoL; JMML; aCML; MDS/MPN-RS-T; MDS/MPN, unclassifiable; if the diagnosis was other than an overlap syndrome, continue with question 100. Questions 88-89: Did the recipient have splenomegaly? Indicate if the…

Q56-68: Laboratory Studies at Diagnosis

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2018: LYM Pre-Infusion » Q56-68: Laboratory Studies at Diagnosis

Questions 56-68 will be enabled / disabled in FormsNet3SM based on the histology reported in question 1. Reporting instructions for specific questions are provided at the bottom of this page for reference. All values reported in questions 56-68 must reflect testing…

Q14-31: Laboratory Studies at Diagnosis

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2010: AML Pre-Infusion » Q14-31: Laboratory Studies at Diagnosis

All values reported in questions 14-31 must reflect testing performed prior to any treatment of AML. If testing was not performed near the time of diagnosis (within approximately 30 days) and prior to the initiation of treatment, the center should report “Unknown”…

Q34-58: Laboratory Studies at Diagnosis

Comprehensive Disease-Specific Manuals » 2028/2128: Aplastic Anemia » 2028: Aplastic Anemia Pre-Infusion » Q34-58: Laboratory Studies at Diagnosis

*Laboratory Studies at Diagnosis: The intent of questions 34 – 58 is to capture the laboratory values known PRIOR to the first RBC and / or platelet transfusion. If assessments were performed multiple times, report the most recent value prior to the first RBC and /…

Q140-152: Laboratory Studies at Transformation

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2018: LYM Pre-Infusion » Q140-152: Laboratory Studies at Transformation

Questions 140-152 will be enabled / disabled in FormsNet3SM based on the histology reported in question 84. Reporting instructions for specific questions are provided at the bottom of this page for reference. All values reported in questions 140-152 must reflect…

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…

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…

Q29-42: Laboratory Studies at Diagnosis

Infection & Miscellaneous Manuals » 2553: VOD/SOS » Q29-42: Laboratory Studies at Diagnosis

Question 29-42: Laboratory studies at diagnosis These questions are intended to determine liver function at the time of VOD/SOS diagnosis. Report testing performed on the date of diagnosis. If testing was not performed on the date of diagnosis, report the closest…

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…

Q23-47: Clinical Features and Laboratory Studies at Diagnosis

Comprehensive Disease-Specific Manuals » 2039/2139: Hemophagocytic Lymphohistiocytosis (HLH) » 2039: HLH Pre-HCT » Q23-47: Clinical Features and Laboratory Studies at Diagnosis

*Report findings prior to any treatment of the primary disease for which the HCT is being performed. Question 23: Anemia (Hgb < 9 g/dL): Indicate if the recipient had anemia at diagnosis or prior to the start of treatment for HLH. Anemia is defined as hemoglobin less…

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…

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…

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…

Q31-41: Laboratory Studies at the Time of Evaluation for This Reporting Period

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2134: XLP Post-HCT » Q31-41: Laboratory Studies at the Time of Evaluation for This Reporting Period

Questions 31-32: Serum ferritin Indicate whether serum ferritin level was “known” or “unknown” during the reporting period. If “known,” report the value and unit of measure documented on the laboratory report in question 32. If there are multiple values…

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…

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…

Q188-255:Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2016: PCD Pre-Infusion » Q188-255:Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen

For questions 188-255, report values obtained at the last evaluation prior to the start of the preparative regimen / infusion. If testing is performed multiple times prior to the start of the preparative regimen, report the last test before the start of the preparative…

Q65-91: Laboratory Studies 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 » Q65-91: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen

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

Q64-91: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2011: ALL Pre-Infusion » Q64-91: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

All values reported in questions 64-91 must reflect the most recent testing prior to the start of the preparative regimen (or infusion if no preparative regimen was given. Do not report testing performed during a line of therapy reported in questions 20-68. If testing…

Q157-193: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2014: Myelodyplastic Syndrome (MDS) Pre-Infusion » Q157-193: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Question 157: Date CBC with differential tested Report the date the sample was collected for testing and continue with question 158. If multiple studies were performed, report the last assessment prior to the start of the preparative regimen or infusion. Questions…

Q192-252: Laboratory Studies 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 » Q192-252: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Questions 192-252 refer to the most recent laboratory studies performed prior to the start of the preparative regimen (or prior to infusion if no preparative regimen was given). “Unknown” should only be reported if there isn’t any documentation or it’s unclear…

Q213-254: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion » Q213-254: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Question 213: Date CBC with differential drawn Report the date of the CBC with differential was drawn at the last evaluation prior to the start of the preparative regimen / infusion and continue with question 214. If multiple assessments were performed, report the…

Q69-96: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2010: AML Pre-Infusion » Q69-96: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

All values reported in questions 69-96 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 33-68. If testing…

Q108-127: Clinical Features and Laboratory Studies At Last Evaluation Prior to the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2039/2139: Hemophagocytic Lymphohistiocytosis (HLH) » 2039: HLH Pre-HCT » Q108-127: Clinical Features and Laboratory Studies At Last Evaluation Prior to the Start of the Preparative Regimen

Question 108: Anemia (Hgb < 9 g/dL): Indicate if the recipient had anemia at the last evaluation prior to the start of the preparative regimen. Anemia is defined as hemoglobin less than 9 g/dL. Select “yes,” “no,” or “unknown.” Question 109: Degranulation…

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…

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…

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…

2039: HLH Pre-HCT

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

The Hemophagocytic Lymphohistiocytosis Pre-HCT Data Form is one of the Comprehensive Report Forms. This form captures HLH-specific Pre-HCT data such as the disease assessment, clinical and laboratory features at diagnosis, history of infection, pre-transplant therapy,…

Q665-672: Subsequent HCT

Comprehensive Baseline & Follow-up Manuals » 2100: Post-HCT Follow-Up » Q665-672: Subsequent HCT

*Subsequent Transplant Complete this section if the recipient received a subsequent HCT (question 3, answered “yes”). In addition to this section, a new Pre-TED Form (Form 2400) and Recipient Baseline Data Form (Form 2000) must be completed for the subsequent HCT.…

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…

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,…

2016 Manual Updates

Getting Started » Getting Started » 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…

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…

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…

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…

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…

MDS Response Criteria

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

MDS Response Criteria MDS Response Criteria Complete Remission (CR) Requires all of the following maintained for a minimum of four weeks. When reporting the CR achievement date, report the first date when CR was achieved (not the four week date in which CR was…

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…

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…

Q1-5: Indication

Recipient Assignment, Indication, and Information Manuals » 2820: Recipient Contact Information » Q1-5: Indication

Question 1: Did this Form 2820 become due because the recipient agreed to direct contact by CIBMTR for research studies as indicated on Form 2400? This question should be answered ‘yes’ if the recipient has given permission to be directly contacted by CIBMTR for…

Q51-105: Clinical Status of Recipient Post-HCT

Comprehensive Disease-Specific Manuals » 2033/2133: Wiskott-Aldrich Syndome (WAS) » 2133: WAS Post-HCT » Q51-105: Clinical Status of Recipient Post-HCT

Question 51: Did the recipient experience any types of bleeding (since the date of last report)? Due to WAS-associated thrombocytopenia, bleeding episodes are frequently observed. Indicate whether the recipient experienced any types of bleeding since the date of last…

Q9-11: Best Response to Cellular Therapy

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q9-11: Best Response to Cellular Therapy

This section may not fit perfectly to all possible indications for cellular therapy. Please select the response that is most applicable to the indication for treatment. *If the primary disease reported is Acute Lymphoblastic Leukemia (ALL), Chronic Lymphocytic…

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…

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…

Q24-43: Hematopoietic Cellular Transplant (HCT) and Cellular Therapy

Transplant Essential Data (TED) Manuals » 2400: Pre-TED » Q24-43: Hematopoietic Cellular Transplant (HCT) and Cellular Therapy

Question 24: Is a subsequent HCT planned as part of the overall treatment protocol (not as a reaction to post-HCT disease assessment) (For autologous HCTs only) If, at the time of the current HCT, a second (tandem transplant) or subsequent HCT is planned according to…

Introduction

General Instructions » Introduction

The Center for International Blood and Marrow Transplant Research (CIBMTR) brings together the expertise and unique resources of two leaders in the field of blood and marrow transplant research: the National Marrow Donor Program® (NMDP) and the Medical College 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…

Q1-72: 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,…

2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion

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

The Myeloproliferative Neoplasms Pre-HCT Data Form is one of the Comprehensive Report Forms. This form captures MPN-specific pre-HCT data such as: disease assessment at diagnosis, laboratory studies at diagnosis, pre-HCT therapy, disease transformation, most recent…

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,…

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.…

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:…

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…

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…

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…

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…

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…

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…

Q1-63: 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…

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…

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…

POEMS Response Criteria

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

General Reporting Guidelines Use the POEMS response criteria when determining the disease status for POEMS. Immunofixation (IFE) and immunoelectrophoresis (IEP) are essentially measuring the same thing and either may be used to determine CR. Electrophoresis (SPEP…

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…

Q110-194: Post-HCT / Post-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2112: CML Post-Infusion Data » Q110-194: Post-HCT / Post-Infusion Therapy

*Therapy for Persistent Disease Report treatment for persistent disease (excluding MRD) in questions 110-132. Do not include therapy which has already been reported in questions 64-99 (planned therapy including maintenance and consolidation) unless the treatment is…

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…

Q55-212: Pre-HCT / Pre-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion » Q55-212: Pre-HCT / Pre-Infusion Therapy

The FormsNet3SM application allows questions 56-211 to be reported multiple times. Complete these questions for each line of therapy administered on or after the date of diagnosis of MPN and prior to the start of the preparative regimen (or prior to infusion if no…

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…

Q78-95: Laboratory Findings Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2028/2128: Aplastic Anemia » 2028: Aplastic Anemia Pre-Infusion » Q78-95: Laboratory Findings Prior to the Start of the Preparative Regimen / Infusion

*Laboratory Findings Prior to the Start of the Preparative Regimen / Infusion: For questions 80 – 97, report all findings within two months prior to the start of the preparative regimen. If the assessment was performed multiple times, report the most recent results…

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…

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…

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…

Q178 – 215: Hematologic Parameters Immediately Prior to the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2029/2129: Fanconi Anemia / Constitutional Anemia » 2029: Fanconi Anemia / Constitutional Anemia Pre-HCT » Q178 – 215: Hematologic Parameters Immediately Prior to the Preparative Regimen

Question 178: Was the recipient’s bone marrow examined at any time between the diagnosis and the preparative regimen? Indicate whether a karyotype was performed on the recipient’s bone marrow at any time between the diagnosis of Fanconi Anemia and the start of the…

2026/2126: Neuroblastoma

Comprehensive Disease-Specific Manuals » 2026/2126: Neuroblastoma

Neuroblastoma is an extracranial solid malignancy that predominately affects children between the ages of 1 and 51. The malignant cells arise from neuroblasts of the neural crest; precursors of the sympathetic nervous system. The abdomen is the most common site of…

Q20-30: Current Assessment of Immunologic Fuction Post-HCT

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2134: XLP Post-HCT » Q20-30: Current Assessment of Immunologic Fuction Post-HCT

Question 20: Did the recipient receive supplemental intravenous immunoglobulins (IVIG)? IVIG is a product made from pooled human plasma that primarily contains IgG. It is used to provide immune-deficient recipients with antibody function to prevent infection.…

Recipient Assignment, Indication, and Information Manuals

Recipient Assignment, Indication, and Information Manuals

Find information for the 2804: CIBMTR Research ID Assignment Form, 2814: Indication for CRID Assignment Form, and 2820: Recipient Contact Information Form in the navigation of the table of contents. The 2804 and 2814 forms are required to receive a CRID for a new…

2018: LYM Pre-Infusion

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2018: LYM Pre-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…

2820: Recipient Contact Information

Recipient Assignment, Indication, and Information Manuals » 2820: Recipient Contact Information

The Recipient Contact Information Form 2820 collects contact information on recipients who have agreed to be contacted directly by the CIBMTR for the purpose of inviting them to participate in research activities. If the recipient is a minor, contact information for…

Q33-51: Assessment of Immunologic Function at Diagnosis

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2034: XLP Pre-HCT » Q33-51: Assessment of Immunologic Function at Diagnosis

Report findings from immune function studies at the time of diagnosis; if multiple studies were performed, report the initial values. Question 33: NK cell function Natural killer (NK) cells are cytotoxic lymphocytes implicated in viral response and tumor…

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…

Q69-81: Assessment of Nodal and Organ Involvement at Diagnosis

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2018: LYM Pre-Infusion » Q69-81: Assessment of Nodal and Organ Involvement at Diagnosis

All values reported in questions 69-81 must reflect testing / evaluations performed prior to any treatment for the histology specified in question 1. If testing / evaluation was not done near the time of diagnosis (within approximately 30 days) and prior to the…

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…

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…

2019: WM Pre-HCT

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

The Waldenström’s Macroglobulinemia/Lymphoplasmacytic Lymphoma Pre-HCT Data Form is one of the Comprehensive Report Forms. This form captures WM/LPL-specific pre-HCT data such as: the recipient’s clinical and genetic findings at the time of diagnosis and prior to…

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…