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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)…

Q44-82: Donor Information

Transplant Essential Data (TED) Manuals » 2400: Pre-TED » Q44-82: Donor Information

Question 44: Multiple donors? Indicate if cells from multiple different donors (multiple CBUs, combinations of other products from different donors) are to be used for this HCT. If Yes, continue with question 45. If No, continue with question 46. For example,…

4000: Cellular Therapy Essential Data Pre-Infusion

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion

This form must be completed for all recipients of cellular therapy (non-HCT) with or without a prior HCT. Recipients of CAR T cells, donor lymphocyte infusions, tumor-infiltrating lymphocytes, cytotoxic T cells are common cellular therapies that should be reported…

Q144-170: Donor/Infant Demographic Information

Comprehensive Baseline & Follow-up Manuals » 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion » Q144-170: Donor/Infant Demographic Information

The Donor Demographic Information section (questions 144-170) is to be completed for all non-NMDP allogeneic donors / CBUs. If the stem cell product was from an NMDP donor or an autologous donor, continue with the signature lines at the end of the form. Question 144:…

Q6: Cellular Therapy

Recipient Assignment, Indication, and Information Manuals » 2814: Indication for CRID Assignment » Q6: Cellular Therapy

Question 6: Planned infusion date Report the planned date of cellular infusion. If the planned date of infusion changes, the electronic form should be updated in FormsNet3SM, as this data field is used to populate the date of infusion on the patient’s other case…

Cellular Therapy Manuals

Cellular Therapy Manuals

The sections below provide explanatory text for instructions on completing the Cellular Therapy Essential Data Pre-Infusion Form (F4000), Cellular Therapy Product Form (F4003), Cellular Therapy Infusion Form (F4006), and Cellular Therapy Essential Data Follow-Up Form…

Q47: Product Infusion

Cellular Therapy Manuals » 4003: Cellular Therapy Product » Q47: Product Infusion

Question 47: Specify the total number of planned infusions of this product: (as part of the course of cellular therapy) Report the number of infusions specified per protocol. This question is used to make the correct number of Cellular Therapy Infusion (4006) forms…

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…

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…

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)…

2010: AML Pre-Infusion

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

The Acute Myelogenous Leukemia Pre-Infusion Data Form (Form 2010) is one of the Comprehensive Report Forms. This form captures AML-specific pre-infusion data such as: the recipient’s hematologic findings at the time of diagnosis and prior to the start of the…

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…

Q94-143: Product Infusion

Comprehensive Baseline & Follow-up Manuals » 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion » Q94-143: Product Infusion

Question 94: Date of this product infusion: Report the date this product was infused. If the product was infused over multiple days, report the first date of infusion. Question 95: Was the entire volume of received product infused? Indicate “yes” if the entire…

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…

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,…

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…

2110: AML Post-Infusion

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

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

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…

2026: Neuroblastoma Pre-Infusion

Comprehensive Disease-Specific Manuals » 2026/2126: Neuroblastoma » 2026: Neuroblastoma Pre-Infusion

The Neuroblastoma Pre-HCT Data Form (Form 2026) is one of the Comprehensive Report Forms. This form captures neuroblastoma specific pre-HCT data such as: the recipient’s clinical and laboratory findings at the time of diagnosis and prior to the start of the…

2118: LYM Post-Infusion

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

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

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…

2126: Neuroblastoma Post-Infusion

Comprehensive Disease-Specific Manuals » 2026/2126: Neuroblastoma » 2126: Neuroblastoma Post-Infusion

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

2016: PCD Pre-Infusion

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

The Plasma Cell Disorder Pre-Infusion Data Form (Form 2016) is one of the Comprehensive Report Forms. This form captures PCD-specific pre-infusion data such as: disease classification at diagnosis, hematologic findings at the time of diagnosis and prior to the start of…

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…

Q4-8: Subsequent Cellular Infusions

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q4-8: Subsequent Cellular Infusions

Combined follow up In scenarios where both HCT and cellular therapy forms are being completed, duplicate questions will exist between the Cellular Therapy Essential Data Follow-Up (4100) form and the Post-HCT Data (2100) or Post-Transplant Essential Data (2450) form.…

Q8-10: Non-Cellular Therapy

Recipient Assignment, Indication, and Information Manuals » 2814: Indication for CRID Assignment » Q8-10: Non-Cellular Therapy

Questions 8-9: Specify the disease for which non-cellular therapy was given Indicate if the individual is participating in the BMT CTN 17 – 02 study or receiving non-cellular therapy as treatment for MDS, multiple myeloma, myelofibrosis, sickle cell disease, or…

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…

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.…

2112: CML Post-Infusion Data

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

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

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…

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: 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: 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…

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:…

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…

Q58-77: Indication for Cellular Therapy

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion » Q58-77: Indication for Cellular Therapy

Question 58: What was the primary indication for performing treatment with cellular therapy? From the list provided, select the primary indication for which the recipient is receiving the cellular therapy. If the indication is in the list below and the cell therapy…

Q2-5: Hematopoietic Cellular Transplant (HCT)

Recipient Assignment, Indication, and Information Manuals » 2814: Indication for CRID Assignment » Q2-5: Hematopoietic Cellular Transplant (HCT)

Questions 2-4: Specify the planned cell source(s) for this HCT Indicate if the recipient will be receiving cells from an autologous, related allogeneic, or unrelated allogeneic source. Indicate all that apply; if the recipient is receiving multiple products, ensure…

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: The name of the product reported will be auto populated from what was reported on the Pre-Cellular…

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…

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…

2046: Fungal Infection Pre-Infusion Data

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

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

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…

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”…

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…

2157: Myeloproliferative Neoplasm (MPN) Post-Infusion

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

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

2149: Respiratory Virus Post-Infusion Data

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

In an effort to collect data on the impact of the COVID-19 (SARS-CoV-2) pandemic on our transplant and cellular therapy recipients, CIBMTR released the Respiratory Virus Post-Infusion Data (2149) Form. This form captures information regarding the diagnosis, treatment,…

4100: Cellular Therapy Essential Data Follow-Up

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

This form must be completed for all recipients of cellular therapy (non-HCT), including post-HCT “DCI / DLI” infusions. For recipients of hematopoietic cellular transplants, complete the appropriate HCT follow-up form. The Post-Cellular Therapy Essential Data…

2114: Myelodysplastic Syndrome (MDS) Post-Infusion

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

This form must be completed for all recipients who are randomized to the Comprehensive Report Form (CRF) track and whose primary disease is reported on the Pre-TED Disease Classification Form (Form 2402) as “Myelodysplastic Syndrome (MDS) (50)” The Myelodysplastic…

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…

Q18-32: Cellular Therapy and HCT History

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

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

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…

Q87-104: Post-HCT / Post-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2157: Myeloproliferative Neoplasm (MPN) Post-Infusion » Q87-104: Post-HCT / Post-Infusion Therapy

Question 87: Was therapy given since the date of last report for reasons other than relapsed, persistent, or progressive disease including detection of minimal residual disease or decreased / loss of donor chimerism? (include any maintenance therapy) Indicate if the…

Q78-84: Lymphodepleting Therapy Prior to Cellular Therapy

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion » Q78-84: Lymphodepleting Therapy Prior to Cellular Therapy

Question 78: Was lymphodepleting therapy given prior to the infusion? (does not include lines of therapy given for disease treatment, bridging therapy, or maintenance) Lymphodepleting therapy is given to destroy lymphocytes and T cells. Indicate Yes or No if the…

Q41-50: Post-HCT / Post-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2110: AML Post-Infusion » Q41-50: Post-HCT / Post-Infusion Therapy

Question 41: Was therapy given since the date of last report for reasons other than relapse or persistent disease? Indicate if the recipient received treatment post-infusion for reasons other than relapse or persistent disease during the current reporting period.…

Appendix D: How to Distinguish Infusion Types

Appendices » Appendix D: How to Distinguish Infusion Types

This appendix includes definitions of Hematopoietic Stem Cell Transplant (HCT), Cellular Therapies, Supplemental Infusions, and Autologous Cells Given for Graft Failure. For more information see Table 1. Table 1. Distinguishing Infusion Types* *A preparative…

Q35-47: Post-HCT / Post-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2111: ALL Post-Infusion » Q35-47: Post-HCT / Post-Infusion Therapy

Question 35: Was therapy given since the date of last report for reasons other than relapse or persistent disease? Indicate if the recipient received treatment post-infusion for reasons other than relapse or persistent disease during the current reporting period.…

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…

2006: Hematopoietic Stem Cell Transplant (HCT) Infusion

Comprehensive Baseline & Follow-up Manuals » 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion

Centers must complete the Form 2006 for each product when the recipient is assigned to the Comprehensive Report Form track. Centers must also complete the Form 2006 for the following product types when the recipient is assigned to the Transplant Essential Data…

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…

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…

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…

Q35-54: History of Antiviral Therapy for Hepatitis – Donor

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2047: Hepatitis Serology Pre-HCT » Q35-54: History of Antiviral Therapy for Hepatitis – Donor

Complete questions 35-54 for allogeneic transplants only; if donor information is unknown, leave the data field blank. Complete all data fields for which relevant donor information is documented and available to the CIBMTR center completing the form. Question 35: Did…

Q21-35: Post-HCT or Post-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2118: LYM Post-Infusion » Q21-35: Post-HCT or Post-Infusion Therapy

!Post-Infusion Therapy Prior versions of the lymphoma post-infusion manuals have instructed centers to report treatment for persistent disease in the same data fields as treatment for relapse / progression. The current version of the manual instructs centers to report…

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…

Q64-99: Post-HCT / Post-Infusion Planned Therapy

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2112: CML Post-Infusion Data » Q64-99: Post-HCT / Post-Infusion Planned Therapy

Question 64: 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,…

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

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

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

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,…

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…

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…

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…

Gemtuzumab ozogamicin (Mylotarg™) Administration Pre – HCT / Pre-Infusion

Infection & Miscellaneous Manuals » 2543: Mylotarg™ Supplemental Data Collection » Gemtuzumab ozogamicin (Mylotarg™) Administration Pre – HCT / Pre-Infusion

Question 1: Purpose of therapy Indicate purpose of therapy: Induction (frontline) Consolidation/intensification after achieving first CR/Cri Maintenance/ continuation after achieving first CR/Cri Reinduction after fist disease relapse or later…

Q27-34: Serological Evidence of Prior Hepatitis Exposure / Infection – Donor

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2047: Hepatitis Serology Pre-HCT » Q27-34: Serological Evidence of Prior Hepatitis Exposure / Infection – Donor

Complete questions 27-34 for allogeneic transplants only; if donor information is unknown, leave the data field(s) blank. Complete all data fields for which relevant donor information is documented and available to the CIBMTR center completing the form. Question 27:…

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…

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…

Q104-117: Socioeconomic Information

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

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

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…

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

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

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

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…

Q6–21: Recipient Contact Information

Recipient Assignment, Indication, and Information Manuals » 2820: Recipient Contact Information » Q6–21: Recipient Contact Information

Question 6 – 7: First Name, Last Name Report the recipient’s complete legal first name in question 1 and complete legal last name in question 2. Question 8: Indicate language preference: Select the recipient’s primary language preference. If the…

Q39–58: Alternate Contact Information

Recipient Assignment, Indication, and Information Manuals » 2820: Recipient Contact Information » Q39–58: Alternate Contact Information

This section will enable when a specific study requires an alternate contact, such as a caregiver, who is not the recipient’s parent / guardian. This section is currently disabled as it is not required for the following studies: BMT CTN 1702, BMT CTN 1703, or BMT CTN…

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…

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…

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…

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…

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

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

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

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

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

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

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…

Q22–38: Parent / Legal Guardian Contact Information

Recipient Assignment, Indication, and Information Manuals » 2820: Recipient Contact Information » Q22–38: Parent / Legal Guardian Contact Information

Question 22 – 23: First Name, Last Name Report the complete legal first name of the recipient’s parent / legal guardian in question 22 and complete legal last name in question 23. Question 24: Indicate language preference Select the parent / legal…

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…

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

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

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

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…

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…

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

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

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

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…

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…

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…