Q26: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder

!New Malignancies
Report new malignancies that are different than the disease / disorder for which cellular therapy was performed. Do not include relapse, progression or transformation of the same disease subtype. New malignancy related questions will now be asked on the Subsequent Neoplasm (3500) form.

Combined follow up
In scenarios where an HCT was given after a cellular therapy and this form is now being completed based on the subsequent HCT, new malignancies will always be reported on the Cellular Therapy Essential Data Follow- Up (4100) forms and disabled on the Post-HSCT Data (2100) or Post-Transplant Essential Data (2450).

Question 26: 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, 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)
  

*Post-Transplant Lymphoproliferative Disorder (PTLD)
PTLD should be reported as a new malignancy if it was confirmed via a biopsy (treatment not required) or suspected to be PTLD and treated.

*Recurrent Skin Cancers
For most malignancies, do not report recurrence, progression or transformation of the recipient’s primary disease (disease for which the transplant was performed) or relapse of a prior malignancy in the “New Malignancy” section.
For example, a recipient had a basal cell skin cancer diagnosed on the neck four months post-infusion and six months later had another basal cell located on the nose. The lesion on the nose is not considered a metastasis from the neck, but a new discrete lesion. These discrete episodes should be reported as Basal cell skin malignancy on the Post-CTED forms.

If a new malignancy, lymphoproliferative disorder, or myeloproliferative disorder was diagnosed during the reporting period, report Yes and complete the Subsequent Neoplasms (3500) Form, which will come due.

The Previously reported option should only be used if the same malignancy has already been reported on a Subsequent Neoplasms (3500) form that was made do 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. In this scenario, report Yes, the recipient developed a new malignancy, and a Subsequent Neoplasms (3500) form will be completed to report the new malignancy information. For all future reporting periods, select No.

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, Previously reported, will be reported since a prior Subsequent Neoplasms (3500) form has already been submitted for the new malignancy.

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^SM 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. Select Yes to create a second Subsequent Neoplasms (3500) form.

Section Updates:

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