Question 82: Is the lymphoma histology reported at diagnosis a transformation from CLL?
CLL may evolve to a more aggressive diffuse large B-cell lymphoma (DLBCL). This is commonly referred to as Richter’s syndrome or Richter’s transformation. Note, CLL may also transform into Hodgkin lymphoma.
Indicate if recipient’s lymphoma histology at diagnosis, as reported above, is a transformation from CLL. If Yes, complete a CLL Pre-Infusion (2013) Form.
Questions 83 – 85: Did the recipient transform to a different lymphoma histology between diagnosis and the start of the preparative regimen / infusion? (not CLL)
Transformation may occur when a slow-growing lymphoma with an indolent clinical history changes to a more aggressive lymphoma. An example of a common transformation would include follicular lymphoma evolving to a diffuse large B-cell lymphoma (DLBCL).
Specify if a transformation occurred concurrently with the diagnosis of the initial lymphoma histology, as reported above, or between the diagnosis of the initial lymphoma histology and the start of the preparative regimen / lymphodepleting therapy (or infusion if preparative regimen / lymphodepleting therapy wasn’t administered).
If Yes, specify the lymphoma histology at transformation. If the histology at transformation is Other B-cell lymphoma or Other T-cell / NK-cell lymphoma, specify the histology.
If there were multiple transformations, the least aggressive lymphoma histology should be reported as the histology at diagnosis (reported above) and the most aggressive lymphoma histology captured in this question. The lymphoma histologies identified between the diagnosis of the initial lymphoma (least aggressive histology) and the transformation to the most aggressive histology are not captured.
Question 86: Was documentation submitted to the CIBMTR? (e.g., path report)
Indicate whether documents were attached to support the reported histology at transformation. Attaching pathology reports at diagnosis in FormsNet3SM may prevent future data queries. For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide
Question 87: Was the date of transformation the same as the date of diagnosis?
If a concurrent diagnosis (the initial lymphoma, least aggressive, and transformed lymphoma identified at the same time) has occurred, it is not necessary to repeat the diagnosis information in the transformation section of the report.
Indicate if the date of the transformation was identified is the same as the original diagnosis date.
Question 88: Date of transformation
Report the date the transformation was diagnosed. Enter the date the sample was collected for examination. If the date of transformation was determined at an outside center, and no documentation of a pathological or laboratory assessment is available, a dictated date within a physician note may be reported.
If the exact date is not known, use the process described for reporting partial or unknown dates in General Instructions, General Guidelines for Completing Forms.
Question 89: Were immunohistochemical stains obtained? (at transformation)
Immunohistochemical staining (IHC) is a process where tissue samples are treated with antibodies and dye. The antibodies bind to specific antigens on the surfaces of the cells, allowing for the identification of those cell surface markers under microscopy. Testing is often documented in the pathology report from the tissue sample, on which IHC was used.
Indicate if IHC was completed at transformation.
Questions 90 – 108: Immunohistochemical stain results
Testing may be performed on multiple sample types at transformation. Report testing performed on samples taken from the node / mass, if available. If IHC was not done on the node / mass or the results are not known, report testing performed on the bone marrow instead. If IHC results are unclear as this information may be documented differently across hospitals / laboratories, consult a physician.
For each marker, specify if the results were Positive, Negative, or Unknown based on the IHC results at transformation. If the report documents “dim” for a specific marker, report this as Positive.
Report Unknown for markers which were not tested or were tested, but the results are not known.
If Positive is reported for any of the markers listed below, indicate whether the percent of cells positive for this marker (as determined by IHC) is known. If Known, report the percent of cells positive for the specified marker.
- BCL-2
- BCL-6
- C-MYC
- Ki-67
If the percentage is documented as a range, report the average. If the percent is documented as less than a specified percent, report the percent specified minus one (e.g., report < 10% as 9%). If the percentage is documented as more than a specified percent, report the percentage specified plus one. (e.g., report > 90% as 91%).
Question 109: Were cytogenetics tested (karyotyping or FISH)?
Cytogenetics is the study of chromosomes. This assessment involves testing blood or bone marrow for known chromosomal abnormalities that reflect the recipient’s disease. For more information about cytogenetic testing and terminology, see Appendix C: Cytogenetics. Indicate whether cytogenetic studies were performed at transformation.
Indicate whether cytogenetic studies were obtained at transformation.
Questions 110 – 111: Were cytogenetics tested via FISH?
Specify if FISH studies were performed at transformation and specify if abnormalities were detected.
If FISH studies were not performed at transformation, unknown if completed, or if FISH samples were inadequate or the results ‘failed’, report No.
Report chromosomal microarrays / chromosomal genomic arrays as FISH assessments.
See Appendix C: Cytogenetics, for assistance interpreting FISH results.
Questions 112 – 133: Specify FISH abnormalities
For each abnormality specify if it was detected via FISH at transformation.
- Report Yes if the abnormality was detected at transformation
- Report No if the abnormality was assessed and not detected at transformation
- Report Not done if the abnormality was not assessed or could not successfully be performed at transformation
If a clonal abnormality is detected, but not listed as an option, select Yes for Other abnormality and specify the abnormality. If multiple other abnormalities were detected, report “see attachment” and attach the final report(s) for any other abnormalities detected.
For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide.
Question 134: Was documentation submitted to the CIBMTR? (e.g., FISH report)
Indicate if a FISH testing report is attached to support the findings reported above.
For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide.
Questions 135 – 136: Were cytogenetics tested via karyotyping?
Specify if karyotyping was performed at transformation and specify if abnormalities were detected. If karyotyping failed or the sample was inadequate, select Yes and specify the results as No evaluable metaphases.
If karyotyping was not performed at transformation or unknown if completed, report No.
See Appendix C: Cytogenetics, for assistance interpreting karyotype results.
Questions 137 – 138: Specify karyotyping abnormalities (check all that apply)
Select all abnormalities detected by karyotyping at transformation. If a clonal abnormality is detected, but not listed as option, select Other abnormality and specify the abnormality. If multiple other abnormalities were detected, report “see attachment” and attach the final report(s) for any other abnormalities detected.
For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide
Question 139: Was documentation submitted to the CIBMTR? (e.g., karyotyping report)
Indicate if a karyotyping report is attached to support the findings reported above.
For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide
Section Updates:
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