All values reported in questions 22-73 must reflect testing performed prior to any treatment of CLL/SLL/PLL. If testing was not performed near the time of diagnosis and prior to the initiation of treatment, the center should report unknown for that value. An exception is question 40, leukemia cell type, which may not be confirmed until after treatment is started. Centers should report the cell type if confirmed at any time prior to HCT or cellular therapy.
Question 22-23: WBC
Indicate whether the white blood count (WBC) in the peripheral blood is “known” or “unknown” at the time of diagnosis. If “known,” report the laboratory value and unit of measure documented on the laboratory report. If “unknown,” skip question 23 and continue with question 24.
Question 24-25: Hemoglobin (untransfused):
Indicate whether the hemoglobin is “known” or “unknown” at the time of diagnosis. If the recipient is receiving red blood cell (RBC) transfusions, ensure no RBC transfusions have been given within 30 days of the value reported. If “known,” report the laboratory value and unit of measure documented on the laboratory report. If “unknown,” skip question 25 and continue with question 26.
Report “unknown” if no testing was performed at least 30 days after any RBC transfusions were being given at the time of diagnosis.
Question 26-27: Platelets (untransfused):
Indicate whether the platelet count is “known” or “unknown” at the time of diagnosis. If the recipient is receiving platelet transfusions, ensure no platelet transfusions have been given within 7 days of the value reported. If “known,” report the laboratory value and unit of measure documented on the laboratory report. If “unknown,” skip question 27 and continue with question 28.
Report “unknown” if no testing was performed at least 7 days after any platelet transfusions being given at the time of diagnosis.
Question 28-29: Lymphocytes:
Indicate whether the percentage of lymphocytes is “known” or “unknown” at the time of diagnosis. If “known,” report the laboratory value documented on the laboratory report. If “unknown,” skip question 29 and continue with question 30.
Question 30-31: Prolymphocytes
Indicate whether the percentage of prolymphocytes in the peripheral blood is “known” or “unknown” at the time of diagnosis. If “known,” report the laboratory value documented on the laboratory report. If “unknown,” skip question 31 and continue with question 32.
Question 32-34: LDH:
Indicate whether the lactate dehydrogenase (LDH) value is “known” or “unknown” at the time of diagnosis. If “known,” report the laboratory value and unit of measure documented on the laboratory report. If “unknown,” skip question 33-34 and continue with question 35.
If known, indicate the upper limit of normal for LDH at the institution where testing was performed.
Question 35-37: Serum β2 microglobulin
Indicate whether the serum β2 microglobulin is “known” or “unknown” at the time of diagnosis. If “known,” report the laboratory value and unit of measure documented on the laboratory report. If “unknown,” skip question 36-37 and continue with question 38.
If known, indicate the upper limit of normal for the serum β2 at the institution where testing was performed.
Question 38-39: Lymphocytes in bone marrow:
Indicate whether the percentage of lymphocytes in the bone marrow is “known” or “unknown” at the time of diagnosis. If “known,” report the laboratory value documented on the laboratory report. If “unknown,” skip question 39 and continue with question 40.
Question 40: Leukemia cell type
Indicate the leukemic cell type as either B-cell or T-cell. Cell type can be determined using immunophenotyping techniques such as flow cytometry and may be determined at diagnosis or prior to the initiation of therapy. If the leukemic cell type was not determined at diagnosis or prior to the start of therapy, select “unknown” and continue with question 41.
Question 41-42: Were tests for molecular markers performed (e.g. PCR) at the time of diagnosis?
Molecular markers for disease refer to specific genetic sequences which are believed to be associated with the recipient’s primary disease. Testing for these sequences is often performed using PCR based methods; however, lower sensitivity testing, including FISH, may also be used to detect molecular markers. Once a marker has been identified, these methods can be repeated to detect minimal residual disease (MRD) in the recipient’s blood, marrow, or tissue.
If testing for molecular markers was performed at the time of CLL diagnosis, report “yes” and indicate the sample collection date in question 42. 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.
If no molecular marker testing was performed or it is unknown if testing was done, report “no” or “unknown” respectively and skip questions 42-51.
Question 43-51: Specify results
For each molecular marker in questions 43-50, report whether testing was “positive,” “negative,” or “not done.” If tests identified a molecular marker other than those listed in questions 43-48, report the result in question 49 and specify the marker in question 50.
If multiple “other molecular markers” were tested at diagnosis, report “see attachment” in question 50 and attach the final reports for any other markers which were tested. In this scenario, report “positive” in question 49 if any of the “other molecular markers” were detected.
Indicate if documentation was submitted to the CIBMTR (e.g., pathology report) in question 51. For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide.
Question 52: Was flow cytometry (immunophenotyping) performed at the time of diagnosis?
Flow cytometry (immunophenotyping) is a technique that can be performed on blood, bone marrow, or tissue preparations where cell surface markers can be detected on cellular material.
If flow cytometry (immunophenotyping) was performed at the time of diagnosis or prior to the start of therapy, report “yes” and continue with question 53. If not, report “no” and skip questions 53-60.
Question 53-60: Specify flow cytometry results performed at the time of diagnosis
For each cell surface marker in questions 53-60, report whether testing was “positive,” “negative,” or “not done.” If flow cytometry was not performed for a given marker, report “not done.”
Question 61: Were cytogenetics tested (karyotyping or FISH) at the time of diagnosis?
Cytogenetic analysis is the study of chromosomes. Cytogenetic assessment involves testing blood or bone marrow for the presence of a known chromosomal abnormality that reflects the recipient’s disease. Testing methods you may see include conventional chromosome analysis (karyotyping) or fluorescence in situ hybridization (FISH). For more information about cytogenetic testing and terminology, see Appendix C.
Karyotyping is performed by culturing cells (growing cells under controlled conditions) until they reach the dividing phase. Techniques are then performed to visualize the chromosomes during cell division so that various bands and reconfigurations can be seen. Banding pattern differentiation and chromosomal reconfiguration demonstrate evidence of disease.
FISH is a sensitive technique that assesses a large number of cells. This technique uses special probes that recognize and bind to fragments of DNA commonly found in CLL. These probes are mixed with cells from the recipient’s blood. A fluorescent “tag” is then used to visualize the binding of the probe to the diseased cells. FISH may be used as surveillance for changes associated with post-therapy malignancy.
If cytogenetic studies were obtained at diagnosis, report “yes” and continue with question 62.
If cytogenetic studies were attempted, but there were not adequate cells (metaphases), report “yes,” and specify “no evaluable metaphases” in question 62; skip questions 63-73.
If no cytogenetic studies were obtained or it is unknown if chromosome studies were performed, report “no” or “unknown” respectively in question 63 and skip questions 63-73.
Question 62: Results of test
Indicate if cytogenetic studies identified any clonal abnormalities (any karyotype other than 46XX or 46XY) at the time of diagnosis. For karyotype studies, a clonal abnormality is defined as an abnormality detected in two or more cells. For FISH studies, the level of detection should be above the upper limit of normal as specified in the report. If an upper limit is not specified and the FISH result indicates an abnormality was present, consult a physician to determine whether the abnormality ought to be reported.
If chromosomal abnormalities were detected, indicate “abnormalities identified,” continue with question 63.
If cytogenetic studies yielded “no evaluable metaphases” or there were “no abnormalities” identified, skip questions 63-73.
Questions 63-73: Specify results
For each cytogenetic abnormality, report whether testing was positive (yes) or negative (no). Refer to question 62 for further information on how to determine if a testing is positive or negative for a clonal abnormality. If an abnormality was detected, but cannot be reported in question 63-70, report “yes” for question 71 and specify any abnormalities detected and not already reported above in question 72.
For more information regarding cytogenetic terminology and nomenclature, see Appendix C.
Indicate whether documentation (cytogenetic or FISH report) was submitted to the CIBMTR in question 73. 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) |
|---|---|---|---|---|
| Q40 | 2/28/2022 | Modify | Instructions updated to clarify timepoint: Indicate the leukemic cell type as either B-cell or T-cell. Cell type can be determined using immunophenotyping techniques such as flow cytometry and |
Updated to clarify timepoint. |
| Q52 | 2/28/2022 | Modify | Instructions updated to clarify timepoint: Flow cytometry (immunophenotyping) is a technique that can be performed on blood, bone marrow, or tissue preparations where cell surface markers can be detected on cellular material. If flow cytometry (immunophenotyping) was performed at the time of diagnosis or prior to the start of therapy, report “yes” and continue with question 53. If not, report “no” and skip questions 53-60. | Updated to clarify timepoint. |
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