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 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.

Figure 1. Disabled Edit Form Icon

Figure 2. Hovered Text, Consent Not Yet Reported

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.

Links to Sections of the Form:
Q1 – 2: Primary Disease for HCT
Q3 – 103: Acute Myelogenous Leukemia
Q104 – 179: Acute Lymphoblastic Leukemia
Q180 – 183: Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms
Q184 – 194: Chronic Myelogenous Leukemia
Q195 – 274: Myelodysplastic Diseases
Q275 – 387: Myeloproliferative Diseases
Q388 – 394: Other Leukemia
Q395 – 412: Hodgkin and Non-Hodgkin Lymphoma
Q413 – 459: Multiple Myeloma / Plasma Cell Disorder
Q460 – 461: Solid Tumors
Q462 – 464: Severe Aplastic Anemia
Q465: Inherited Bone Marrow Failure Syndromes
Q466 – 501: Hemoglobinopathies
Q502 – 509: Disorders of the Immune System
Q510 – 511: Inherited Abnormalities of Platelets
Q512 – 514: Inherited Disorders of Metabolism
Q515 – 519: Histocytic Disorders
Q520 – 523: Autoimmune Diseases
Q524 – 525: Tolerance Induction Associated with Solid Organ Transplant
Q526: Other Disease

Manual Updates:
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.

If you need to reference the historical Manual Change History for this form, review the table below or reference the retired manual section on the Retired Forms Manuals webpage.

Date Manual Section Add/Remove/Modify Description
10/17/2022 2402: Disease Classification Modify Instructions updated for Q391 updated for clarification: Histologic transformation may occur after CLL diagnosis. Indicate if CLL transformed into diffuse large B-cell lymphoma (known as Richter’s transformation or Richter’s syndrome). If CLL transformed, select Yes, and continue with the Hodgkin / Non-Hodgkin Lymphoma section. If CLL did not transform, select No and report the disease status. Always report this question as No. This question will be updated in future releases. If CLL transformed, the primary disease should be reported as Hodgkin lymphoma or Non-Hodgkin’s lymphoma – do not report the primary disease as Other leukemia.
10/17/2022 2402: Disease Classification Add Red instruction box added above Q391: CLL with Richter’s Transformation If the recipient is receiving an infusion for CLL and there was a Richter’s transformation to lymphoma, the primary disease for infusion should be reported as Hodgkin lymphoma (150) or Non-Hodgkin’s lymphoma (100) and not Other Leukemia (30).
9/23/2022 2402: Disease Classification Modify Version 7 of the 2402: Pre-TED Disease Classification section of the Forms Instructions Manual released. Version 7 corresponds to revision 7 of the Form 2402.
Last modified: Oct 17, 2022

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