Question 34: 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 Yes or No if a new or second primary malignancy, including lymphoproliferative disorder, or myeloproliferative disorder, developed in the current reporting period. 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 (3500) form to answer questions specific to the new malignancy. The option of ‘Previously reported’ should only be used if the same malignancy has already been reported on a Subsequent Neoplasms (3500) form that was made due on demand. See examples below. If it is unclear whether or not to use of this option, contact CIBMTR Center Support if there are questions.

Example 1. Recipient develops a new malignancy at day +68. It is reported at the time the 100-day Cellular Therapy Essential Data Follow-Up (4100) form is completed. Question 34 should be answered as ‘yes’ and the Subsequent Neoplasms (3500) form should be completed to report all new malignancy information.

Example 2. Recipient received a commercial CAR-T product and develops a new malignancy at day +68. Per protocol, the new malignancy should be reported at the time of knowledge of the new malignancy. The Subsequent Neoplasms (3500) form should be created as an unscheduled form in FormsNet3 and completed in a timely manner. In this example, no other new malignancy develops during the 100-day reporting period. When the 100-day Cellular Therapy Essential Data Follow-Up (4100) form is completed, question 34 should be answered as ‘previously reported’.

Example 3. Recipient received a commercial CAR-T product and develops a new malignancy at day +68. Per protocol, the new malignancy should be reported at the time of knowledge of the new malignancy. The Subsequent Neoplasms (3500) form should be created as an unscheduled form in FormsNet3 and completed in a timely manner. Another new malignancy develops at day +100 after the same CAR-T infusion. It is decided to report the 2nd new malignancy on the 100-day Cellular Therapy Essential Data Follow-Up (4100) form since it is due at the same time. Question 34 should be answered as ‘yes’ to create a second Subsequent Neoplasms (3500) form.

Section Updates:

Question Number Date of Change Add/Remove/Modify Description Reasoning (If applicable)
. . . . .
Last modified: Jan 22, 2021

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