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CLL Response Criteria

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

Complete Response (CR)1 All of the following: No evidence of lymphadenopathy2 No organomegaly Neutrophils ≥ 1.5 × 109/L Platelets > 100 × 109/L Hemoglobin > 11 g/dL Lymphocytes < 4 × 109/L Bone marrow < 30% lymphocytes Absence of…

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…

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…

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,…

Lymphoma Response Criteria

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

Metabolic Criteria Complete Remission (CR) Complete metabolic remission requires all of the following: A score of 1, 2, or 3 with or without a residual mass on a PET 5 point scale; and Disappearance of any previously non-measured lesions; and No new lesions;…

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…

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…

MPN Response Criteria

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » MPN Response Criteria

MPN Response Criteria1 CR (requires each of the following) Requires all of the following maintained for a minimum of 12 weeks. When reporting the CR achievement date, report the first date when CR was achieved (not the 12 week date in which CR was maintained). Bone…

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…

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…

CML Response Criteria

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

*For recipients with CML, the disease status may be tracked by molecular and cytogenetic (karyotype and/or FISH) assessments. However, for reporting purposes, the disease status should only be reported based off of clinical / hematologic assessments. For example, a…

Neuroblastoma Response Criteria

Comprehensive Disease-Specific Manuals » 2026/2126: Neuroblastoma » Neuroblastoma Response Criteria

Complete Response (CR) Complete response requires all of the following: Disappearance/resolution of primary tumor No evidence of metastatic sites Catecholamines normal Very Good Partial Remission (VGPR) Very good partial remission requires all of the…

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…

JMML Response Criteria

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » JMML Response Criteria

Complete Remission (CR) Normalization of WBC and resolution of organomegaly. Partial Remission (PR) ≥ 50% reduction of WBC from maximum pre-treatment value and/or ≥ 50% reduction of organomegaly from pre-treatment maximum Marginal Response (MR) 25-50%…

Waldenstrom’s Macroglobulinemia Response Criteria

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

*Reporting Disease Status on the Pre-TED Disease Classification (2402) Form: Not all of the Waldenstrom’s Macroglobulinemia response criteria correspond to the option values on the current Pre-TED Disease Classification (2402) Form. Please see the italicized text…

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…

Plasma Cell Leukemia Response Criteria

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

General Reporting Guidelines At any response level, if some but not all criteria are met, the disease status should be downgraded to next lower level of response. The percentage of plasma cells in the bone marrow aspirate and / or biopsy may also be identified on a…

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…

Appendix F: Response Evaluation Criteria in Solid Tumors (RECIST)

Appendices » Appendix F: Response Evaluation Criteria in Solid Tumors (RECIST)

Response Evaluation Criteria in Solid Tumors (RECIST) The Response Evaluation Criteria in Solid Tumors (RECIST) were published in February 2000 by the European Organization for Research and Treatment of Cancer (EORTC), the National Cancer Institute of the United…

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…

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…

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

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

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

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,…

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…

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…

Q54-109: Organ Parameters of Amyloidosis at the Time of Best Response

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2116: PCD Post-Infusion » Q54-109: Organ Parameters of Amyloidosis at the Time of Best Response

!Complete questions 54-109 for amyloid patients only. If diagnosis was other than amyloidosis or there is no history of it, continue with question 110. The response time for amyloidosis tends to occur well after transplant, so the “best response” to transplant may…

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…

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…

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…

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,…

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…

Q372-378: Other Leukemia

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

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

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…

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…

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

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

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

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…

Q379-396: Hodgkin and Non-Hodgkin Lymphoma

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q379-396: Hodgkin and Non-Hodgkin Lymphoma

Hodgkin lymphoma (HL or Hodgkin disease) is a cancer of the immune system that is marked by the presence of a type of cell called the Reed-Sternberg cell. The two major types of Hodgkin lymphoma are classical Hodgkin lymphoma (90-95% of cases) and nodular…

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…

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…

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…

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…

Q27-42: Post-HCT / Post-Infusion Planned Therapy

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2113: CLL Post-Infusion » Q27-42: Post-HCT / Post-Infusion Planned Therapy

Question 27: Was therapy given since the date of last report for reasons other than relapse or progressive disease? (Include any maintenance and consolidation therapy.) Indicate if the recipient received treatment post-Infusion for reasons other than relapse,…

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,…

Appendix N: Drug Classification

Appendices » Appendix N: Drug Classification

This appendix includes common drugs administered as part of BMT treatment and therapy. Drug classifications, descriptions, and examples of each drug class are described in Table 1. Classification Category Agent Description Examples BTK…

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.…

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…

2018 Manual Updates

Getting Started » Getting Started » 2018 Manual Updates

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

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…

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…

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…

Q84-185: Pre-HCT or Pre-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2012: CML Pre-Infusion Data » Q84-185: Pre-HCT or Pre-Infusion Therapy

The FormsNet3SM application allows questions 85-185 to be reported multiple times. Complete these questions for each line of therapy administered prior to the start of the preparative regimen (or prior to infusion if no preparative regimen was given). When submitting…

General Guidelines for Completing Forms

General Instructions » General Guidelines for Completing Forms

Fields Requiring a Date For fields that require a date, if an exact date is not known use the process listed below. This process should be used only if the dates fit within the logical timeframe of the form (i.e. contact date, diagnosis date, relapse date, etc). To…

Q253-311: Current Status of Amyloidosis for this Reporting Period

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2116: PCD Post-Infusion » Q253-311: Current Status of Amyloidosis for this Reporting Period

!Complete questions 253-311 for amyloidosis patients only. If amyloidosis was not reported as the primary disease for infusion (question 1) or as a preceding / concurrent disorder (question 2), skip to question 312. *Current Disease Status The center does not need to…

Q49-62: Pre-HCT Therapy

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » 2015: JMML Pre-HCT » Q49-62: Pre-HCT Therapy

!Lines of Therapy and Subsequent Infusions If this is a subsequent infusion and a 2015 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2015. Please report from post previous infusion to time of…

2020 Manual Updates

Getting Started » Getting Started » 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…

Q157-187: Pre-HCT Therapy

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2016: PCD Pre-Infusion » Q157-187: Pre-HCT Therapy

!Lines of Therapy and Subsequent Infusions If this is a subsequent infusion and a 2016 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2016. Please report from post previous infusion to time of…

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…

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…

Q76-120: Pre-HCT Therapy

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2019: WM Pre-HCT » Q76-120: Pre-HCT Therapy

Complete a “Line of Therapy” section for each line of therapy administered prior to the start of the preparative regimen. If multiple lines of therapy are administered, copy and complete questions 77-120 for each line of therapy. !Lines of Therapy and Subsequent…

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…

2116: PCD Post-Infusion

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

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

Q59-70: Pre-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2028/2128: Aplastic Anemia » 2028: Aplastic Anemia Pre-Infusion » Q59-70: Pre-Infusion Therapy

A single line of therapy refers to any agents administered during the same time period with the same intent. If a recipient’s response changes resulting in a change of treatment, a new line of therapy should be reported. Additionally, if therapy is changed because a…

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.…

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…

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…

2057/2157 Myeloproliferative Neoplasms (MPN)

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN)

Myeloproliferative neoplasms (MPN) are characterized by the overproduction of blood cells (red blood cells, white blood cells, and/or platelets) or collagen in the bone marrow. Often the MPN will be identified due to a blood test for another condition, as some patients…

Transplant Essential Data (TED) Manuals

Transplant Essential Data (TED) Manuals

The Transplant Essential Data (TED) Manual section contains information on the successful completion of TED forms. The Pre-TED Manual has several links to disease specific response criteria which can be found in the Comprehensive Disease Specific Manual…

Q24-32: History of Epstein Barr Virus (EBV) Infection

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2034: XLP Pre-HCT » Q24-32: History of Epstein Barr Virus (EBV) Infection

Question 24: Is there a history of EBV infection? Epstein-Barr virus (EBV) is one of the human herpes viruses (Herpesviridae family). It is the virus that causes infectious mononucleosis, commonly referred to as “mono.” XLP may present as an exaggerated immune…

Appendices

Appendices

These sections include additional information referenced in other manuals. Appendix A: Abbreviations and Definitions Appendix B: Glossary of Terms Appendix C: Cytogenetic Assessments Appendix D: How to Distinguish Infusion Types Appendix E: Definition of a…

2016/2116: Plasma Cell Disorders (PCD)

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

The blood is composed of platelets, red blood cells, and several kinds of white blood cells. One kind of white blood cells, the plasma cells (also called plasma B cells, plasmocytes, or effector B cells) produce proteins called antibodies or immunoglobulins (Igs) that…

Q62 – 232: Laboratory Values at Diagnosis of Neuroblastoma

Comprehensive Disease-Specific Manuals » 2026/2126: Neuroblastoma » 2026: Neuroblastoma Pre-Infusion » Q62 – 232: Laboratory Values at Diagnosis of Neuroblastoma

*Laboratory Studies at Diagnosis The intent of questions 62 -232 is to capture the laboratory 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…

Appendix M: HCT Critical Data Fields

Appendices » Appendix M: HCT Critical Data 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…

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…

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.…

Q1-17: Inotuzumab Ozogamicin (Besponsa™)

Infection & Miscellaneous Manuals » 2541: Inotuzumab Ozogamacin (Besponsa™) Supplemental Data » Q1-17: Inotuzumab Ozogamicin (Besponsa™)

Questions 1-2: Did the recipient receive more than one cycle of Inotuzumab Ozogamicin (Besponsa™)? (1 cycle = 3 doses) Indicate “Yes” if more than one cycle (1 cycle = 3 doses) of Inotuzumab Ozogamicin was given. If “Yes” provide the number of cycles in…

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…

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…

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.,…

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

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

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

Q32-68: Pre-HCT or Pre-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2010: AML Pre-Infusion » Q32-68: Pre-HCT or Pre-Infusion Therapy

The FormsNet3SM application allows questions 33-68 to be reported multiple times. Complete these questions for each line of therapy administered on or after the date of diagnosis of AML and prior to the start of the preparative regimen (or prior to infusion if no…

Q20-63: Pre-HCT or Pre-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2011: ALL Pre-Infusion » Q20-63: Pre-HCT or Pre-Infusion Therapy

The FormsNet3SM application allows questions 28-63 to be reported multiple times. Complete these questions for each line of therapy administered on or after the date of diagnosis of ALL and prior to the start of the preparative regimen (or prior to infusion if no…

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…

Q82-156: Pre-HCT / Pre-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2014: Myelodyplastic Syndrome (MDS) Pre-Infusion » Q82-156: Pre-HCT / Pre-Infusion Therapy

The FormsNet3SM application allows questions 83-157 to be reported multiple times. Complete these questions for each line of therapy administered on or after the date of diagnosis of MDS and prior to the start of the preparative regimen (or prior to infusion if no…

Q73-87: Post-HCT / Post-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2114: Myelodysplastic Syndrome (MDS) Post-Infusion » Q73-87: Post-HCT / Post-Infusion Therapy

Question 73: Was therapy given since the date of last report for reasons other than relapse or persistent disease? (include any maintenance therapy) Indicate if the recipient received treatment post-infusion for reasons other than relapse or persistent disease during…

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…

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…

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…

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…

2014/2114: Myelodysplastic Syndrome (MDS)

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

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

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…

2019/2119: Waldenström’s Macroglobulinemia (WM)

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

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

2010/2110: Acute Myelogenous Leukemia (AML)

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

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…

Q259-371: Myeoloproliferative Diseases

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q259-371: Myeoloproliferative Diseases

*Transformation to AML: If the recipient is being transplanted for AML that has transformed from MPN, the primary disease for HCT must be reported as AML. Disease Classification questions must be completed for both AML and MPN. *Transformation to…

Q142-210: Post-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2116: PCD Post-Infusion » Q142-210: Post-Infusion Therapy

Question 142: Was therapy given since the date of last report for reasons other than relapse or progressive disease? (Include any maintenance and consolidation therapy prior to relapse as well as therapy given for persistent disease that has not progressed): Indicate…

2019 Manual Updates

Getting Started » Getting Started » 2019 Manual Updates

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

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…

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…