Q53-72: Indication for Cellular Therapy

Question 53: 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 is being given with HCT or post-HCT, no additional consent is required from the patient per CIBMTR. Please confirm with your local IRB:

• GVHD prophylaxis (with HCT)
• GVHD treatment (post-HCT)
• Immune reconstitution (post-HCT)
• Infection prophylaxis
• Prevent disease relapse (post-HCT)
• Suboptimal donor chimerism (post-HCT)

The Disease Classification (2402) Form will come due if the indication is reported as Malignant hematologic disorder, Non-malignant disorder, or Solid tumor. This allows CIBMTR to capture disease specific information for cellular therapy utilizing an existing form to maintain consistency in data collection.

If the recipient is receiving post-HCT cellular therapy (e.g., DCI) for relapsed, persistent, or progressive disease, the indication should be recorded as Malignant hematologic disorders and complete a new Disease Classification (2402) form for the disease that has relapsed / persisted / progressed. This will capture / confirm the diagnosis and reporting the disease status prior to the DCI.

*If the indication for cellular therapy is cardiovascular disease, musculoskeletal disorder, neurologic disease, ocular disease or pulmonary disease, follow up on the Cellular Therapy Essential Data Follow-Up (4100) form is not required.

*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 indication” category should be used only if the recipient’s disease is not one of the listed options. For more information regarding disease classification, visit the WHO website and consult a transplant physician, as needed. If any questions remain after review with the transplant physician, visit the WHO website or contact CIBMTR Center Support if there are questions.

*Malignant vs. Non-Malignant
Malignant disease involves cells dividing without control that can spread to other parts of the body through blood and lymph systems. These diseases are usually characterized by unlimited, aggressive growth, invasion of surrounding tissues, and metastasis. Non- malignant tumors involve cell overgrowth but lack the malignant properties of cancer. Non- malignant diseases include severe aplastic anemia, disorders of the immune system, inherited disorders of metabolism, etc. The CIBMTR database disease codes are represented in parentheses after the disease subtype on the Disease Classification questions and can be helpful in mapping diagnosis [e.g., Myeloid Sarcoma (295)] and determining if the disease is malignant or non-malignant. Disease codes (10-299) indicate a malignant disease, with the exception of Paroxysmal Nocturnal Hemoglobinuria (PNH) (56). A disease code of (300) or above indicates a non- malignant disease, with the exception of disease code (900), which could indicate either a malignant or non-malignant disease.

Question 54: Date of diagnosis:

If the primary indication for the cellular therapy is cardiovascular disease, musculoskeletal disease, neurologic disease, ocular disease, pulmonary disease, infection treatment or other indication, report the diagnosis date of the primary indication. The diagnosis date for malignant hematologic disorder, non-malignant disorder or solid tumor will be captured on the Disease Classification (2402) form.

Report the date (YYYY-MM-DD) of the first pathological diagnosis (e.g., bone marrow or tissue biopsy) of the disease for which the patient is receiving cellular therapy. Enter the date the sample was collected for examination. If the indication is infection, report the date of diagnosis as the collection date for the first positive microbiology culture. If the diagnosis was determined at an outside center, and no documentation of a pathological or laboratory assessment is available, the dictated date of diagnosis within a physician note may be reported. Do not report the date symptoms first appeared.

If the recipient was diagnosed prenatally (in utero) or if the indication is a congenital disorder, report the date of birth as the date of diagnosis.

If the exact pathological diagnosis date is not known, use the process described in General Instructions, General Guidelines for Completing Forms.

Question 55-57: Specify cardiovascular disease:

If cardiovascular disease is the indication for cellular therapy, indicate the specific disease. If Other cardiovascular disease is selected, specify the other cardiovascular disease. If Other peripheral vascular disease is selected, specify the other peripheral vascular disease.

Report “induced cardiomyopathy” as Heart failure (non-ischemic etiology) (703).

Question 58-59: Specify musculoskeletal disorder:

If musculoskeletal disorder is the indication for cellular therapy, indicate the specific disorder. If Other musculoskeletal disorder is selected, specify the other musculoskeletal disorder.

Question 60-61: Specify neurologic disease:

If neurologic disease is the indication for cellular therapy, indicate the specific disease. If the specific disease is not explicitly listed, select the broad category for the primary indication for infusion.

If Other neurologic disease is selected, specify the other neurologic disease.

Question 62: Specify ocular disease:

If ocular disease is the indication for the cellular therapy, specify the ocular disease. Examples include treatment of glaucoma or photoreceptor degeneration

Question 63-64: Specify pulmonary disease:

If pulmonary disease is the indication for the cellular therapy, specify the pulmonary disease. If Other pulmonary disease is selected, specify the other pulmonary disease.

Question 65-71: Specify the organism for which the cellular therapy is being given to treat:

If infection treatment is the indication for the cellular therapy, indicate the organism(s) being treated.

Organism:
From Table 1 entitled “Codes for Commonly Reported Organisms”, select the code corresponding to the identified organism as indicated on the microbiology report, laboratory report, or other physician documentation. Report the code in the boxes provided on the form.

Fungal infections: Note the inclusion of Pneumocystis (formerly found under parasites). The most commonly found fungal infections are Candida (C. albicans), Aspergillus (A. fumigatus), and Fusarium sp.

Viral infections: Caused by exposure to a new virus or reactivation of a dormant virus already present in the body. The most common viral infections are due to HSV (Herpes Simplex Virus), and CMV (Cytomegalovirus). If the site of CMV is the lung, confirm whether the patient had interstitial pneumonitis rather than CMV pneumonia.

Table 1: Codes for Commonly Reported Organisms

210 Aspergillus, NOS	503 Suspected fungal infection	309 Human Immunodeficiency Virus 1 or 2
211 Aspergillus flavus	304 Adenovirus	343 Human metapneumovirus
212 Aspergillus fumigatus	341 BK Virus	322 Human Papillomavirus (HPV)
213 Aspergillus niger	344 Coronavirus (excluding COVID-19 (SARS-CoV-2))	349 Human T-lymphotropic Virus 1 or 2
215 Aspergillus terreus	350 COVID-19 (SARS-CoV-2)	310 Influenza, NOS
214 Aspergillus ustus	303 Cytomegalovirus (CMV)	323 Influenza A Virus
270 Blastomyces (dermatitidis)	347 Chikungunya virus	324 Influenza B Virus
201 Candida albicans	346 Dengue Virus	342 JC Virus (Progressive Multifocal Leukoencephalopathy (PML))
208 Candida non- albicans	325 Enterovirus (ECHO, Coxsackie)	311 Measles Virus (Rubeola)
271 Coccidioides (all species)	327 Enterovirus D68 (EV-D68)	312 Mumps Virus
222 Cryptococcus gattii	326 Enterovirus (polio)	345 Norovirus
221 Cryptococcus neoformans	328 Enterovirus NOS	316 Human Parainfluenza Virus (all species)
230 Fusarium (all species)	318 Epstein-Barr Virus (EBV)	314 Respiratory Syncytial Virus (RSV)
261 Histoplasma (capsulatum)	306 Hepatitis A Virus	321 Rhinovirus (all species)
241 Mucorales (all species)	307 Hepatitis B Virus	320 Rotavirus (all species)
260 Pneumocystis (PCP / PJP)	308 Hepatitis C Virus	315 Rubella Virus
242 Rhizopus (all species)	340 Hepatitis E	302 Varicella Virus
272 Scedosporium (all species)	301 Herpes Simplex Virus (HSV)	348 West Nile Virus (WNV)
240 Zygomycetes, NOS	317 Human herpesvirus 6 (HHV-6)	504 Suspected viral infection
		777 Other organism

Question 72: Specify other indication

If the indication for the cellular therapy does not fit into a category listed, specify the other indication. This option should be used sparingly. Contact CIBMTR Center Support with any questions prior to using this field.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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