Question 33: Did a new malignancy, myelodysplastic, myeloproliferative, or lymphoproliferative disease / disorder occur that is different from the disease / disorder for which the cellular therapy was performed? (Include clonal cytogenetic abnormalities, and post-transplant lymphoproliferative disorders):
Indicate whether a new or second primary malignancy, including lymphoproliferative disorder, or myeloproliferative disorder, has developed. Do not report recurrence, progression, or transformation of the recipient’s primary disease (disease for which the cellular therapy was performed) or relapse of a prior malignancy.
New malignancies, lymphoproliferative disorders, myelodysplastic and myeloproliferative disorders include but are not limited to:
Skin cancers (basal, squamous, melanoma)
- New leukemia
- New myelodysplasia
- Solid tumors
- PTLD (post-transplant lymphoproliferative disorder) report as lymphoma or lymphoproliferative disease
The following should not be reported as new malignancy:
- Recurrence of primary disease (report as relapse or disease progression)
- Relapse of malignancy from recipient’s pre-cellular therapy medical history
- Breast cancer found in other (i.e., opposite) breast (report as relapse)
- Post-cellular therapy cytogenetic abnormalities associated with the pre-cellular therapy diagnosis (report as relapse)
If a new malignancy is reported, please complete the Subsequent Neoplasms Form 3500 to answer
questions specific to the new malignancy. The option of ‘Previously reported’ should only be used if the same new malignancy instance has already been reported on a F3500. See examples below. If there is a question regarding use of this option, please submit your question via Center Support in the ServiceNow application.
Example 1. Recipient develops a new malignancy at day +68. It is reported at the time the 100-day Form 4100 is completed. Question 33 should be answered as ‘yes’ and the Form 3500 should be completed to report all new malignancy information.
Example 2. Recipient develops a new malignancy at day +68 and had received a commercial CAR-T product. Per protocol, the new malignancy should be reported at the time of knowledge of the new malignancy. The Form 3500 should be created as an unscheduled form in FormsNet3 and completed in a timely manner. No other new malignancy develops during the 100-day reporting period. When the 100-day Form 4100 is completed, question 33 should be answered as ‘previously reported’.
Example 3. Recipient develops a new malignancy at day +68 and had received a commercial CAR-T product. Per protocol, the new malignancy should be reported at the time of knowledge of the new malignancy. The Form 3500 should be created as an unscheduled form in FormsNet3 and completed in a timely manner. Another new malignancy develops at day +100. It is decided to report the 2nd new malignancy on the 100-day Form 4100 since it is due. Question 33 should be answered as ‘yes’ to create another Form 3500.
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