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Q1: Product

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q1: Product

Question 1: Name of Product: (for most recent cell therapy infusion) *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.…

Q1-3: Mobilization

Infection & Miscellaneous Manuals » 2565: Sanofi Mozobil Supplemental Data » Q1-3: Mobilization

Question 1-2: Did the recipient stay at a temporary location closer to the collection center for mobilization? (e.g., hotel) Report “Yes” for question one if the recipient stayed at a temporary location closer to the collection center for mobilization. If the…

Q1-28: Diagnosis

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

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

Q1-9: 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: Subsequent Infusion

Comprehensive Disease-Specific Manuals » 2028/2128: Aplastic Anemia » 2028: Aplastic Anemia Pre-Infusion » Q1: Subsequent Infusion

Question 1: Is this the report of a second or subsequent transplant or cellular therapy for the same disease? Report No and go to question 2 in any of the following scenarios: This is the first infusion reported to the CIBMTR; or This is a second or subsequent…

Q1: Subsequent Transplant

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion » Q1: Subsequent Transplant

Question 1: Is this the report of a second or subsequent transplant or cellular therapy for the same disease? If this is a report of a second or subsequent transplant/cellular therapy for the same disease subtype and this baseline disease insert was not completed for…

Q1 – 6: Survival

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

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

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…

Q1-10: Infection Diagnosis

Infection & Miscellaneous Manuals » 2149: Respiratory Virus Post-Infusion Data » Q1-10: Infection Diagnosis

Question 1: Date of Infection Diagnosis The reported date of COVID-19 (SARS-CoV-2) diagnosis must match the diagnosis date reported on the corresponding follow-up form. Report the date the sample was collected for the first test which confirmed the diagnosis. The…

Q1-2: Disease Specificity

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

Question 1: Specify the multiple myeloma / plasma cell disorder (PCD) classification Specify the indication for transplant. This question will be auto-populated from the Pre-TED Disease Classification and Characteristics (2402) Form. Question 2: Specify preceding /…

Q1-25: Infection Episode

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2046: Fungal Infection Pre-Infusion Data » Q1-25: Infection Episode

Question 1: Organism This field is auto-populated to match the fungus reported on the Baseline Form (Form 2000). Review the value to ensure it is accurate. A Fungal Infection Pre-Infusion Data Form will come due for each applicable infection reported on the Baseline…

Q1-5: Physical Assessments

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion » Q1-5: Physical Assessments

*NOTE: If completing this form for the 100-day reporting period, “date of last report” should be interpreted as “day 0 (i.e., infusion).” Question 1: Date of evaluation Report the date of the most recent physical evaluation where both the abdominal girth and…

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…

Q1-6: Functional Status

Infection & Miscellaneous Manuals » 3501: Pregnancy Form » Q1-6: Functional Status

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

Q1 – 5: Product Identification

Gene Therapy Manuals » 2003: Gene Therapy Product » Q1 – 5: Product Identification

*A Gene Therapy Product (2003) form will be completed for each product administered Question 1: Name of Product The name of the product reported will be auto populated from what was reported on the Pre-TED (F2400) form. Questions 2 – 5: Specify the identifier(s)…

Q1-31: Infection Episode

Infection & Miscellaneous Manuals » 2150: Viral Infection Diagnosis and Treatment Form » Q1-31: Infection Episode

Question 1: Organism This field is auto-populated to match the virus reported on the Post-HCT Follow-Up Data Form (Form 2100). Review the value to ensure it is accurate. A Viral Infection Diagnostic Form will come due for each CMV, EBV, ADV, HHV-6, and BK virus…

Q1-25: Infection Episode

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2146: Fungal Infection Post-Infusion Data » Q1-25: Infection Episode

Question 1: Organism This field is auto-populated to match the fungus reported on the Post-HCT Follow-Up Form (Form 2100). Review the value to ensure it is accurate. A Fungal Infection Post-Infusion Data Form will come due for each applicable infection reported on the…

Q1-5: Vital Status

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up » Q1-5: Vital Status

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

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…

Q1 – 6: Current Hematologic Parameters

Comprehensive Disease-Specific Manuals » 2029/2129: Fanconi Anemia / Constitutional Anemia » 2129: Fanconi Anemia / Constitutional Anemia Post-HCT » Q1 – 6: Current Hematologic Parameters

Question 1: Was the recipient red blood cell (RBC) transfusion independent since the date of the last report? Indicate if the recipient was RBC transfusion independent for the entire reporting period. Some discretion may be required if the recipient received a…

Q1-3: Pre-Collection Therapy

Comprehensive Baseline & Follow-up Manuals » 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion » Q1-3: Pre-Collection Therapy

This section of the HCT Infusion (2006) form captures pre-collection therapy information regarding the donor’s mobilization or priming; this section of the form is not completed for cord blood units or products from NMDP donors. Question 1: Did the donor…

Q1-7: Recipient Death Data

Comprehensive Baseline & Follow-up Manuals » 2900: Recipient Death » Q1-7: Recipient Death Data

Question 1: Date of Death Report the date the recipient died. Confirm that the date matches the last date of actual contact reported on the Post-Infusion Follow-Up (2100) form or Cellular Therapy Essential Data Follow-Up (4100) form. If the death occurred at an…

Q1-3: Complications of Interest

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

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

Q1-2: Disease Assessment at Diagnosis

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

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

Q1: Donor/Cord Blood Unit Identification

Comprehensive Baseline & Follow-up Manuals » 2004: Infectious Disease Markers » Q1: Donor/Cord Blood Unit Identification

Question 1: Who is being tested for IDMs? Indicate whether the donor (for peripheral blood stem cells and/or bone marrow products), mother of an infant cord donor, or cord blood unit itself is being tested for IDMs. Maternal IDMs and cord blood unit IDMs apply only to…

Q1 – 141: Disease Assessment at Diagnosis

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

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

Q1: Subsequent Transplant or Cellular Therapy

Comprehensive Disease-Specific Manuals » 2037 / 2137 Leukodystrophies » 2037: Leukodystrophies Pre-Infusion » Q1: Subsequent Transplant or Cellular Therapy

Question 1: Is this the report of a second or subsequent transplant or cellular therapy for the same disease? Report No and go to question 2 in any of the following scenarios: This is the first infusion reported to the CIBMTR; or This is a second or subsequent…

Q1: Subsequent Transplant of Cellular Therapy

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2014: Myelodyplastic Syndrome (MDS) Pre-Infusion » Q1: Subsequent Transplant of Cellular Therapy

Question 1: Is this the report of a second or subsequent transplant or cellular therapy for the same disease? If this is a report of a second or subsequent transplant / cellular therapy for the same disease subtype and this baseline disease insert was not completed…

Q1-8: Disease Assessment at Diagnosis

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

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

Q1-50: 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…

Q1: Subsequent Transplant or Cellular Therapy

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q1: Subsequent Transplant or Cellular Therapy

Question 1: Is this the report of a second or subsequent infusion? Report No and go to question 2 in any of the following scenarios: This is the first infusion reported to the CIBMTR; or This is a second or subsequent infusion for a different disease (i.e., the…

Q1-2: Disease Assessment at Diagnosis

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

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

Q1-17: Disease Assessment at Diagnosis

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

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

Q1 – 5: Leukodystrophies Post-Infusion Data

Comprehensive Disease-Specific Manuals » 2037 / 2137 Leukodystrophies » 2137: Leukodystrophies Post-Infusion » Q1 – 5: Leukodystrophies Post-Infusion Data

!Hereditary diffuse leukoencephalopathy (HDLS): If the primary disease for infusion is HDLS, manually select this option from question 1. This option will not auto populate at this time. Question 1: For which type of leukodystrophy was the infusion…

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,…

Q1-23: Disease Assessment at Diagnosis

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

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

Q1-22: Disease Assessment at Diagnosis

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

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

Q1-19: 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”…

Q1-13: Disease Assessment at Diagnosis

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

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

Q1-2: Tepadina® Stop Date

Infection & Miscellaneous Manuals » 2540: Tepadina® Supplemental Data » Q1-2: Tepadina® Stop Date

Questions 1 & 2: Tepadina® stop date !Questions 1-2 can only be completed on the 100 day follow-up form. These questions will be skipped for all subsequent reporting periods. Indicate if Tepadina® stop date is “Known” or “Unknown” in question 1. Start date…

Q1-6: Clinical Features at Diagnosis

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » 2015: JMML Pre-HCT » Q1-6: Clinical Features at Diagnosis

Question 1: What was the date of diagnosis? Juvenile myelomonocytic leukemia (JMML) is characterized by multiple clinical and laboratory features, rather than distinct pathological characteristics. As such, the date of diagnosis should be the date of the last…

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…

Q1-13: Disease Assessment at Diagnosis

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

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

Q1: Donor/Cord Blood Unit Identification

Comprehensive Baseline & Follow-up Manuals » 2005: Confirmation of HLA Typing » Q1: Donor/Cord Blood Unit Identification

*Refer to the General Instructions, Key Fields and Signature Lines section of this manual for assistance editing key fields on this form. Question 1: Specify the person for whom this typing is being done Indicate whether the reported HLA typing is the final recipient…

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…

Q1-17: 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…

Q1-2: Cellular Therapy Product Identification

Cellular Therapy Manuals » 4003: Cellular Therapy Product » Q1-2: Cellular Therapy Product Identification

*If more than one cell therapy product is infused, each product must be reported on a separate Cellular Therapy Product (4003) form. Question 1: Name of product: *If your center considers this to be a Donor Lymphocyte Infusions (DLI), as reported on the Pre-CTED…

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…

Q1 – 61: Clinical and Laboratory Characteristics at Diagnosis

Comprehensive Disease-Specific Manuals » 2026/2126: Neuroblastoma » 2026: Neuroblastoma Pre-Infusion » Q1 – 61: Clinical and Laboratory Characteristics at Diagnosis

Question 1: What was the date of diagnosis of Neuroblastoma? Neuroblastoma is typically diagnosed by histopathologic findings from tumor tissue samples or a bone marrow biopsy. Tumor marker analyses can provide diagnostic assistance. The date of diagnosis should be…

Q4-9: Post-Infusion Critical Illness

Infection & Miscellaneous Manuals » 2542: Mogamulizumab Supplemental Data Collection » Q4-9: Post-Infusion Critical Illness

Questions 4-5: Did the recipient experience a complication of infusion requiring a transfer to an intensive care unit? Report whether the recipient required a transfer to the intensive care unit due to a complication directly related to the infusion. If “yes”…

Q1 – 12: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder

Infection & Miscellaneous Manuals » 3500: Subsequent Neoplasms » Q1 – 12: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder

*Reporting Multiple New Malignancies A single Subsequent Neoplasms (3500) form will come due whenever a new malignancy / disorder is reported on the Post-HCT Follow-Up (2100) or Cellular Therapy Essential Data Follow-Up Form (4100) form. However, if there is a…

Q1-6: Serological Evidence of Prior Hepatitis Exposure / Infection – Recipient

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2047: Hepatitis Serology Pre-HCT » Q1-6: Serological Evidence of Prior Hepatitis Exposure / Infection – Recipient

Question 1: Specify and/or confirm previous Hepatitis B surface antigen (HBsAg) testing performed and reported on the Form 2000 – Recipient Baseline Data The hepatitis B surface antigen is a protein expressed on the surface of the hepatitis B virus. Its presence in…

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…

Q1-32: 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:…

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…

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

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

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

Q1-34: 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…

Q1-3:Clinical Status of Recipient Prior to the Preparative Regimen (Conditioning)

Comprehensive Baseline & Follow-up Manuals » 2000: Recipient Baseline » Q1-3:Clinical Status of Recipient Prior to the Preparative Regimen (Conditioning)

*Infusion Without a Preparative Regimen Questions 1-3 must be answered even if no preparative regimen was given. Question 1: Does the recipient have a history of smoking cigarettes? The intent of this question is to determine the recipient’s history of smoking,…

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,…

Q1-25: 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…

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

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

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

Q1-72: 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,…

Q1-3: 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…

Q1-20: 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…

2000: Recipient Baseline

Comprehensive Baseline & Follow-up Manuals » 2000: Recipient Baseline

A transplant center designated as a Comprehensive Report Form center will submit data on the Pre-TED Form, followed by either the Post-TED Form or the Comprehensive Report Forms. The type of follow-up form used for a specific recipient is determined by the CIBMTR’s…

2133: WAS Post-HCT

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

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

2147: Hepatitis Serology Post-HCT

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2147: Hepatitis Serology Post-HCT

The Hepatitis Serology Post-HCT Data, Form 2147, will come due when the following IDMs are reported as “positive” on the Form 2000, Recipient Baseline Data: Hepatitis B surface antigen Hepatitis B core antibody Hepatitis B DNA Hepatitis C antibody Hepatitis C…

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…

2033: WAS Pre-HCT

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

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

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…

2047: Hepatitis Serology Pre-HCT

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2047: Hepatitis Serology Pre-HCT

The Hepatitis Serology Pre-HCT Data, Form 2047, will come due when any of the following IDMs are reported as “positive” on the Form 2000, Recipient Baseline Data: Hepatitis B surface antigen Hepatitis B core antibody Hepatitis B DNA Hepatitis C…

2134: XLP Post-HCT

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

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

2129: Fanconi Anemia / Constitutional Anemia Post-HCT

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

This form must be completed for all recipients randomized to the Comprehensive Report Form (CRF) track and whose primary disease is reported on the Pre-TED Disease Classification Form (Form 2402) as Inherited Bone Marrow Failure Syndromes with a sub classification of…

2037: Leukodystrophies Pre-Infusion

Comprehensive Disease-Specific Manuals » 2037 / 2137 Leukodystrophies » 2037: Leukodystrophies Pre-Infusion

The Leukodystrophies Pre-Infusion Data Form is one of the Comprehensive Report Forms. This form captures leukodystrophy specific pre-infusion data such as: disease assessments / laboratory studies at diagnosis, pre-infusion treatment and laboratory studies / clinical…

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…

2541: Inotuzumab Ozogamacin (Besponsa™) Supplemental Data

Infection & Miscellaneous Manuals » 2541: Inotuzumab Ozogamacin (Besponsa™) Supplemental Data

Inotuzumab Ozogamicin Supplemental pre-HCT Data Collection Form, Form 2541, must be completed for recipients who are enrolled onto CIBMTR study SC17-10. The study will evaluate safety outcomes post-HCT in patients with B-cell precursor ALL who have been treated with…

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…

2139: HLH Post-HCT

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

The Hemophagocytic Lymphohistiocytosis Post-HCT Data Form is one of the Comprehensive Report Forms. This form captures HLH-specific Post-HCT data such as the disease assessment since the date of the last report. This form must be completed for all recipients…

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)…

2137: Leukodystrophies Post-Infusion

Comprehensive Disease-Specific Manuals » 2037 / 2137 Leukodystrophies » 2137: Leukodystrophies Post-Infusion

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

4006: Cellular Therapy Infusion

Cellular Therapy Manuals » 4006: Cellular Therapy Infusion

This form must be completed for all infusions 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)…

2540: Tepadina® Supplemental Data

Infection & Miscellaneous Manuals » 2540: Tepadina® Supplemental Data

Tepadina® Supplemental post-HCT Data Collection Form, Form 2540, must be completed for recipients who are enrolled onto CIBMTR study SC17-03. This is a multi-center, prospective, observational post-authorization long-term study of the use of thiotepa as part of a…

2128: Aplastic Anemia Post-HCT

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

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

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:…

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…

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)…

3501: Pregnancy Form

Infection & Miscellaneous Manuals » 3501: Pregnancy Form

This form captures information regarding a female recipient’s or a male recipient’s female partner’s pregnancy. This form must be completed when a pregnancy is reported on a Cellular Therapy Essential Data Follow-Up (4100) Form. The Pregnancy (3501) Form will…

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…

2400: Pre-TED

Transplant Essential Data (TED) Manuals » 2400: Pre-TED

*The Pre-TED Form is now required for all transplants, including subsequent transplants on the comprehensive report form track. All transplant centers participating in the CIBMTR must submit a Pre-TED (2400) Form for each allogeneic (related or unrelated)…

2012: CML Pre-Infusion Data

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

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,…

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…

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…

2004: Infectious Disease Markers

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

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

2034: XLP Pre-HCT

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

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

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…

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…

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,…