Q66-85: Indication for Cellular Therapy

Question 66: 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.

*Commercially available products
Select Malignant hematologic disorder as the indication if the product is Abecma®, Aucatzyl®, Breyanzi®, Carvykti®, Kymriah®, Tecartus®, or Yescarta®.

*Commercially available products
Select Solid tumor as the indication if the product is Amtagvi® or Tecelra®.
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 recipient per CIBMTR; however, confirm with the 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 disorder and a new Disease Classification (2402) form will be completed for the disease that has relapsed / persisted / progressed. This will capture / confirm the diagnosis and the disease status prior to the post-HCT cellular therapy.

*Indications Not Requiring the Cellular Therapy Essential Data Follow-Up (4100)
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 Disease Classification (2402) forms use the World Health Organization (WHO) disease classifications. The disease classification questions contain all 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.

Question 67: 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 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.

Use the following guidelines if the recipient was diagnosed with a non-malignant disease:

• Newborn screening: If the diagnosis was made using a newborn screening, report the date of birth as the diagnosis date.
• Genetic testing: If the recipient was not diagnosed with a newborn screening, report the date of genetic testing that confirmed the diagnosis.
• Other definitive assessment: If genetic testing was not completed, report the date of the other definitive assessment (i.e., electrophoresis, flow cytometry, etc.), that confirmed the diagnosis.
• Diagnosis by exclusion: If the diagnosis was made by exclusion (i.e., all assessments returned normal and the diagnosis made clinically), report the date of the clinical diagnosis as documented by the physician.
• Diagnosis at an outside center: If the diagnosis was completed at an outside center (the confirmatory test such as newborn screening, genetic testing, another definitive test, or clinical diagnosis) and the HCT / CT center performs their own confirmatory testing, report the date of the initial confirmatory test as the diagnosis date.
  

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Questions 68-70: 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).

Questions 71-72: 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.

Questions 73-74: 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 75: 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

Questions 76-77: 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.

Questions 78-84: 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:
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.

Question 85: 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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