This form must be completed when a new malignancy is reported on a Cellular Therapy Essential Data Follow-Up Form (Form 4100). Reported new malignancies should be different than the disease / disorder for which cellular therapy was performed. Do not include relapse, progression or transformation of the same disease subtype.
New malignancies, lymphoproliferative disorders, 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)
A separate form 3500 must be submitted to report each new malignancy diagnosed since the date of last report. Reporting a new malignancy / disorder on a Form 4100 will make one Form 3500 due. If more than one new malignancy occurs during a reporting period, the Form 3500 can be made due on demand. Contact your CIBMTR CRC with any questions.
The submission of a pathology report or other supportive documentation for each reported new malignancy is strongly recommended.
Links to sections of the form:
Q1-23: New Malignancy, Lymphoproliferative or Myeloproliferative Disease/ Disorder
Manual Updates:
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.
If you need to reference the historical Manual Change History for this form, please click here or reference the retired manual section on the Retired Forms Manuals webpage.
| Date | Manual Section | Add/Remove/Modify | Description |
|---|---|---|---|
| 1/30/18 | 3500: Subsequent Neoplasms | Add | Version 1 of the 3500: Subsequent Neoplasms section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the Form 3500. |
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