Question 55: Does your center consider this infusion to be a donor lymphocyte infusion (DLI)?
Indicate whether this course of cellular therapy is considered to be a DLI at your center. An infusion can be classified as a “DLI” when:
- The intent is something other than to restore hematopoiesis
- The infusion must be post-HCT, often by the same donor as the HCT
- Indication is suboptimal donor chimerism, immune reconstitution, GVHD treatment, prevent or treat disease relapse (as reported on F4000)
- Composition of cells is lymphocytes
Question 56-57: Is the cellular therapy being given for prevention?
If the cellular therapy is being given for prevention, indicate “yes” and specify the reason in question 57.
Reasons for prevention include:
- GVHD prophylaxis (with HCT)
- Prevent disease relapse (post-HCT)
- Infection prophylaxis
If the indication is in the list above and the cell therapy is being given with HCT or post-HCT, no additional consent is required from the patient.
If the cellular therapy is not being given for prevention, indicate “no” and continue with question 58.
Question 58: What was the indication for performing treatment with cellular therapy?
From the list provided, select the 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:
- Suboptimal donor chimerism (post-HCT)
- Immune reconstitution (post-HCT)
- GVHD treatment (post-HCT)
The Disease Classification Form 2402 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/DLI) for relapsed, persistent, or progressive disease, the indication should be recorded as “malignant hematologic disorders” and complete a new F2402 for the disease that has relapsed/persisted/progressed.
Question 59: Date of diagnosis:
This question is answered if the indication for cellular therapy is cardiovascular disease, musculoskeletal disease, neurologic disease, ocular disease, pulmonary disease, infection treatment or other indication. The diagnosis date for malignant hematologic disorder, non-malignant disorder or solid tumor will be captured on the Disease Classification Form (Form 2402).
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 60-62: Specify cardiovascular disease:
If cardiovascular disease is the indication for cellular therapy, indicate the specific disease in question 60. If “other cardiovascular disease” is selected, specify in question 61. If “other peripheral vascular disease” is selected, specify in question 62. Continue with question 103.
Question 63-64: Specify musculoskeletal disorder:
If musculoskeletal disorder is the indication for cellular therapy, indicate the specific disorder in question 63. If “other musculoskeletal disorder”, specify in question 64. Continue with question 103.
Question 65-66: Specify neurologic disease:
If neurologic disease is the indication for cellular therapy, indicate the specific disease in question 65. If “other neurologic disease”, specify in question 66. Continue with question 103.
Question 67: Specify ocular disease
If ocular disease is the indication for which the recipient is receiving the cellular therapy, specify in question
67. Examples include treatment of glaucoma or photoreceptor degeneration. Continue with question 103.
Question 68: Specify pulmonary disease
If pulmonary disease is the indication for which the recipient is receiving the cellular therapy, specify in question 68. Examples include Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis. Continue with question 103.
Question 69: Specify other indication
If the indication for which the recipient is receiving the cellular therapy is “other indication” because it does not fit into a category listed above, specify the indication in question 69. An example is treatment of autism by cellular therapy. Please submit any questions regarding the indication via Center Support in the ServiceNow application. Continue with question 103.
Need more help with this?
Don’t hesitate to contact us here.