2402: Disease Classification

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.

!Consent Status and Baseline Forms
There has been a change to the functionality of submitting the Pre-Transplant Essential Data (2400), Pre-Transplant Essential Data Disease Classification (2402), and Pre-Cellular Therapy Essential Data (4000) forms. If a consent status has not yet been reported for a recipient, the edit form icon will appear disabled (see Figure 1 below). When the user hovers over the icon, it will display that consent has not yet been reported for that recipient (see Figure 2 below). The user should go to the Consent Tool (see Navigation to the Consent Tool) and document the recipient’s consent status in order to enable the edit icon and allow for completion of the form.

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 FormsNet3^SM 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 – 272: Myelodysplastic Diseases
Q273 – 385: Myeloproliferative Diseases
Q386 – 392: Other Leukemia
Q393 – 410: Hodgkin and Non-Hodgkin Lymphoma
Q411 – 457: Multiple Myeloma / Plasma Cell Disorder
Q458 – 459: Solid Tumors
Q460 – 462: Severe Aplastic Anemia
Q463: Inherited Bone Marrow Failure Syndromes
Q464 – 499: Hemoglobinopathies
Q500 – 507: Disorders of the Immune System
Q508 – 509: Inherited Abnormalities of Platelets
Q510 – 512: Inherited Disorders of Metabolism
Q513 – 517: Histiocytic Disorders
Q518 – 521: Autoimmune Diseases
Q522 – 523: Tolerance Induction Associated with Solid Organ Transplant
Q524: 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
4/19/2025	2402: Disease Classification	Add	ET or PCV to MDS Transformation and Disease Assessments at Diagnosis blue note box added above Q201: ET or PCV to MDS Transformation and Disease Assessments at Diagnosis: If MDS transformed from ET or PCV, report assessments from the time of the MDS transformation. Do not report assessments from the time of ET or PCV diagnosis.
1/24/2025	2402: Disease Classification	Remove	Instructions in Q180 updated: CIBMTR captures the classification of ambiguous lineage and other myeloid neoplasms based on the World Health Organization (WHO) 2022. Indicate the other acute leukemia disease classification at diagnosis. If the subtype is not listed, report as Other acute leukemia of ambiguous lineage or myeloid neoplasm and specify the reported disease. Acute undifferentiated leukemia is a type of AML characterized by immature predominating cells that cannot be classified. Biphenotypic, bilineage, or hybrid leukemias have characteristics representative of both myeloid and lymphoid lineages. Mast cell leukemia is characterized by an increased number of tissue mast cells in the peripheral blood.
1/24/2025	2402: Disease Classification	Add	Myelodysplastic/myeloproliferative neoplasm with neutrophilia and Disease Status added above Q195 and Q390: Myelodysplastic/myeloproliferative neoplasm with neutrophilia and Disease Status: As of October 2024, atypical CML is captured as an MDS and the disease classification is reported as Myelodysplastic/myeloproliferative neoplasm with neutrophilia. The disease status for Myelodysplastic/myeloproliferative neoplasm with neutrophilia will be reported in the Other Leukemia section of the form.
1/24/2025	2402: Disease Classification	Add	ET or PCV to MDS Transformation blue box added above Q198: ET or PCV to MDS Transformation: In the rare event MDS transformed from ET or PCV, report Yes there was a predisposing condition, the condition as Other condition and specify as ET or PCV. Do not report there was a disease transformation below.
1/24/2025	2402: Disease Classification	Add	ET and PCV added as possible other predisposing conditions to report in Q199: A list of entities that would fall into the Other condition category include: ETV6-related familial thrombocytopenia, ANKRD26-related familial thrombocytopenia, SRP72-related familial aplastic anemia / MDS, MBD4-related familial leukemia, Bloom Syndrome, Noonan Syndrome, Neurofibromatosis, Downs Syndrome, ATG2B/GSKIP duplication (chromosome 14q32.2), MECOM-associated syndrome , Essential thrombocythemia (ET), Polycythemia vera (PCV).
1/124/2025	2402: Disease Classification	Modify	CALR Testing blue box updated above Q292: If CALR testing was performed and positive but the lab report does not specify the type, select Not done for CALR 1 and CALR 2, and Positive Not done for Not defined.
10/25/2024	2402: Disease Classification	Modify	Version 9 of the 2402: Pre-TED Disease Classification section of the Forms Instructions Manual released. Version 9 corresponds to revision 9 of the Form 2402.

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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.