Question 57: Did a new malignancy, myeloproliferative, or lymphoproliferative disease / disorder occur that is different from the disease / disorder for which the HCT or cellular therapy was performed? (include clonal cytogenetic abnormalities, and post-transplant lymphoproliferative disorders)

Indicate whether a new or secondary malignancy, lymphoproliferative disorder, or myeloproliferative disorder has developed. 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.

New malignancies, lymphoproliferative disorders, or 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-HCT medical history
  • Breast cancer found in other (i.e., opposite) breast (report as relapse)
  • Post-HCT cytogenetic abnormalities associated with the pre-HCT diagnosis (report as relapse)
  • Transformation of MDS to AML post-HCT (report as disease progression)

If a new malignancy, lymphoproliferative disorder, or myeloproliferative disorder was diagnosed during the reporting period, report Yes. If No, continue with question 65.

Questions 58 – 59: Specify new malignancy

If the new malignancy or disorder does not fit into one of the categories listed, indicate Other new malignancy, and specify.

The submission of a pathology report or other supportive documentation for each reported new malignancy is strongly recommended.

Question 60: Is the tumor EBV positive?

If the disorder is lymphoma or lymphoproliferative disease, indicate if the tumor is EBV positive. This question only applies if Hodgkin lymphoma, Non-Hodgkin lymphoma, or Post-transplant lymphoproliferative disorder (PTLD) is reported as the new malignancy.

Question 61: Date of diagnosis

Report the date of first pathological diagnosis (e.g., biopsy) of the new malignancy. Enter the date the sample was collected for examination. 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.

For malignancies or disorders without pathologic diagnosis, report the date of clinical diagnosis or date of specimen collection for laboratory assessment confirming diagnosis.

If exact date of diagnosis is not known, refer to General Instructions, General Guidelines for Completing Forms, for information about reporting partial or unknown dates.

Question 62: Was documentation submitted to the CIBMTR? (e.g., pathology / autopsy report or other documentation)

Indicate whether documentation of the new malignancy, lymphoproliferative disorder, or myeloproliferative disorder was submitted to CIBMTR (e.g., pathology report, autopsy report).

For further instructions on how to attach documents in FormsNet3SM, refer to the training guide.

Question 63 – 64: Was the new malignancy donor / cell product derived?

Indicate whether the new malignancy originated from the donor / cell product. If Yes, indicate whether documentation was submitted to CIBMTR (e.g., cell origin evaluation (VNTR, cytogenetics, FISH)).

For further instructions on how to attach documents in FormsNet3SM, refer to the training guide.

Section Updates:

Question Number Date of Change Add/Remove/Modify Description Reasoning (If applicable)
Q57 – 64 5/18/2022 Add Combined Follow-Up blue box added: In scenarios where a cellular therapy was given after an HCT and this form is now being completed based on the subsequent cellular therapy date, these questions do not apply and are disabled. Added for clarification
Last modified: May 18, 2022

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