Was flow cytometry performed?:
Report whether flow cytometry was performed as “Yes” or “No”.
If answered Yes complete the questions below regarding the flow cytometry.
Per protocol flow cytometry is required to be completed at screening. If this field is answered No a protocol deviation should be logged in the EDC.
Date flow cytometry performed:
This field will only appear in the EDC if “Was flow cytometry performed?” is answered Yes. Enter the date the test was completed. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
Per protocol flow cytometry is required to be completed within 45 days prior to the anticipated start of the conditioning regimen. If the flow cytometry date entered is outside of those parameters a protocol deviation should be logged in the EDC.
If the date entered is a future date, a query will appear in the EDC.
If disease indication is CLL and Other Leukemia, was flow cytometry performed via immunophenotyping?:
If disease is CLL or Other Leukemia, report whether flow cytometry was performed via immunophenotyping as “Yes,” “No,” or “N/A.” “N/A” option should be used for any disease other than CLL or Other Leukemia.
If answered Yes complete the questions below regarding the flow cytometry.
Per protocol flow cytometry via immunophenotyping is required to be completed at screening for CLL or Other Leukemia. If this field is answered No and disease is CLL or Other Leukemia, a protocol deviation should be logged in the EDC.
Was disease detected?:
This field will only appear in the EDC if “Was flow cytometry performed?” is answered Yes. Report if disease was detected as “Yes” or “No”.
Specify percent disease detected:
This field will only appear in the EDC if “Was disease detected” is answered Yes. Report the subject’s percent of disease detected in %. This field allows up to five characters.
If disease indication is CLL and Other Leukemia, indicate results of flow cytometry cell groups as listed below.
Indicate whether testing was “Positive”, “Negative”, or “Not Done” for the following markers. These fields will only appear in the EDC if “If disease indication is CLL and Other Leukemia, was flow cytometry performed via immunophenotyping?” is answered Yes.
• CD5+
• CD19+
• CD20+
• CD23+
• CD38+
• SIg
• Zap-70 – mutated
Specify CD38+ positivity:
Report the CD38+ positivity percentage by selecting “≥ 30% positivity” or “< 30% positivity”.
CCG v1.0 | CRF v1.3
Post your comment on this topic.