The Disease Classification Form is required for all transplants, including subsequent transplants on the comprehensive report form track and cellular therapy infusions when the indication is malignant hematologic disorder, non-malignant disorder or solid tumor.
All transplant centers participating in the CIBMTR must submit a Disease Classification Form (Form 2402) for each allogeneic (related or unrelated) hematopoietic cell transplant (HCT). The Disease Classification Form is a requirement of the SCTOD for all United States transplant centers when either the stem cell donation or the transplant occurs within the United States. For more information regarding the SCTOD, see General Instructions, Stem Cell Therapeutics Outcomes Database.
Although data regarding recipients receiving autologous HCT are not required to be submitted as part of the C.W. Bill Young Transplant Program, the CIBMTR is highly committed to collecting data on these recipients for research studies. Centers choosing to report autologous data to the CIBMTR must report on all autologous transplants performed at their center. For more information regarding data reporting for autologous HCT, see General Instructions, Autologous Hematopoietic Stem Cell Transplant.
The Disease Classification Form may be submitted to the CIBMTR up to two weeks prior to the start of the recipient’s preparative regimen. The Disease Classification Form is due the day of infusion (day 0), and is past due if not received by that date.
The Disease Classification Form is designed to capture important details regarding the recipient’s primary disease for which the reported HCT is being given. Key reporting areas differ depending on the disease reported (question 1), but may include disease type, subtype, transformations, cytogenetic and molecular markers, disease-specific laboratory results, staging, and disease status.
For recipients receiving a subsequent HCT:
Transplant centers must submit a Disease Classification Form for all subsequent HCTs; this includes recipients assigned to the TED Forms and the Comprehensive Report Forms by the form selection algorithm.
For the majority of subsequent HCTs, the recipient will remain on the original follow-up form track (TED or CRF) assigned by the form selection algorithm. For more information regarding center type and the form selection algorithm, see General Instructions, Center Type and Data Collection Forms. A recipient may need to change tracks if enrolled on a study that requires comprehensive forms.
For recipients of multiple transplants, transplant centers are not granted access to a subsequent Disease Classification Form in FormsNet3SM until the Post-TED (Form 2450) or Post-Infusion Data Form (Form 2100) from the previous transplant has been completed.
Q1-2: Primary Disease for HCT
Q3-95: Acute Myelogenous Leukemia
Q96-163: Acute Lymphoblastic Leukemia
Q164-167: Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms
Q168-178: Chronic Myelogenous Leukemia
Q179-258: Myelodysplastic Diseases
Q259-371: Myeloproliferative Diseases
Q372-378: Other Leukemia
Q379-396: Hodgkin and Non-Hodgkin Lymphoma
Q397-443: Multiple Myeloma / Plasma Cell Disorder
Q444-445: Solid Tumors
Q446-448: Severe Aplastic Anemia
Q449-450: Inherited Bone Marrow Failure Syndromes
Q488-495: Disorders of the Immune System
Q496-497: Inherited Abnormalities of Platelets
Q498-500: Inherited Disorders of Metabolism
Q501-505: Histocytic Disorders
Q506-509: Autoimmune Diseases
Q510-511: Tolerance Induction Associated with Solid Organ Transplant
Q512: Other Disease
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.
|3/22/2021||2402: Disease Classification||Add|| Added the following instruction for question 405:
The Durie-Salmon stage is only required if the recipient’s I.S.S. stage at diagnosis cannot be determined and is not reported in questions 415-416.
|1/25/2021||2402: Disease Classification||Modify||Added clarification to the main page of this manual regarding the edit capabilities of the form due to the release of the Consent Tool on 1/25/2021.|
|1/11/2021||2402: Disease Classification||Add|| Clarification added on how to report the number of lines of therapy prior to infusion when there is a prior infusion and / or transformation along with examples 1 and 2: A single line of therapy refers to any agents administered during the same time period with the same intent (induction, consolidation, etc.). If a recipient’s disease status changes resulting in a change to treatment, this should be considered a new line of therapy. Additionally, if therapy is changed because a favorable disease response was not achieved, this should be considered a new line of therapy. Report the total number of lines of therapy received since the original lymphoma diagnosis up until the start of the preparative regimen / infusion, regardless of if the recipient has received a prior infusion.
Example A: A recipient received a line of induction and achieved CR. However, following induction, the recipient relapsed and received a line of re-induction with no response. After re-induction, the recipient transformed, received a different line of re-induction followed by consolidation and achieved CR2 prior to HCT. This would be considered as four separate lines of therapy and the total number of lines of therapy reported in this example would be “3+ lines.” Example B: A recipient received a line of induction, achieved CR, and then went to HCT. Post-transplant, the recipient transformed, received a line of re-induction followed by a line of consolidation and achieved CR2 prior to the second HCT. In this scenario, the recipient received three lines of therapy and “3+ lines” would be reported.
|11/23/2020||2402: Disease Classification||Add||Blue information box added to Q405 – 406 on how to report the Durie-Salmon staging for subsequent infusions: Durie-Salmon staging: If this form is being completed for a subsequent infusion, report the Durie-Salmon staging at the time of the multiple myeloma diagnosis, and not at the time of relapse or progression|
|10/23/2020||2402: Disease Classification||Modify||Version 6 of the 2402: Pre-TED Disease Classification section of the Forms Instructions Manual released. Version 6 corresponds to revision 6 of the Form 2402.|
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