Disease Classification
Specify the CLL or other leukemia classification at diagnosis:
Report recipient disease classification for CLL or other leukemia from the available options in the dropdown list:
• Chronic lymphocytic leukemia (CLL), NOS
• Chronic lymphocytic leukemia (CLL), B-cell / small lymphocytic lymphoma (SLL)
• Hairy cell leukemia
• Splenic B-cell lymphoma/leukemia with prominent nucleoli
• Monoclonal B-cell lymphocytosis
• Prolymphocytic leukemia (PLL), NOS
• PLL, T-cell
• Other leukemia, NOS
• Other leukemia, specify
Specify other leukemia:
This field will only appear in the EDC if “Specify the CLL or other leukemia classification at diagnosis” is answered Other leukemia, specify. Enter the other leukemia in the text box (up to 200 characters).
Specify the pre-transplant disease status:
Report the subject’s pre-transplant disease status from the following options available in the EDC:
• Complete remission (CR1)
• Partial remission (PR1)
• 2nd Complete remission (CR2)
• 2nd Partial remission (PR2)
• 3rd or greater complete remission (CR3+)
• 3rd or greater partial remission (PR3+)
• Stable disease (SD)
Stable disease must be chemosensitive.
Disease Assessment
Was imaging performed:
Report whether imaging was performed as “Yes” or “No”.
If answered Yes complete the questions below regarding the imaging.
Per protocol imaging is required to be completed at screening. If this field is answered No a protocol deviation should be logged in the EDC.
Date of imaging (CT/PET/MRI):
This field will only appear in the EDC if “Was imaging performed” is answered Yes. Enter the date the imaging 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 imaging is required to be completed within 45 days prior to the anticipated start of the conditioning regimen. If the imaging 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.
Imaging type performed:
This field will only appear in the EDC if “Was imaging performed” is answered Yes. Indicate the type of imaging performed by selecting “CT”, “PET”, or “MRI”.
Was nodal involvement assessed:
Report whether nodal involvement was assessed as “Yes” or “No”.
If answered Yes complete the question below regarding nodal involvement.
Did the recipient have known nodal involvement?:
This field will only appear in the EDC if “Was nodal involvement assessed” is answered Yes. Report whether the recipient had known nodal involvement as “Yes” or “No”.
Was extranodal disease assessed?:
Report whether extranodal disease was assessed as “Yes” or “No”.
If answered Yes complete the questions below regarding the extranodal disease.
Was extranodal disease or splenic involvement present?:
This field will only appear in the EDC if “Was extranodal disease assessed?” is answered Yes. Report whether extranodal disease or splenic involvement is present as “Yes” or “No”.
Specify sites of involvement (check all that apply):
This field will only appear in the EDC if “Was extranodal disease or splenic involvement present?” is answered Yes. Indicate sites of involvement from the list in the EDC (check all that apply). If the site is not available in the list, report “Other site, specify” and specify the site in the text box (up to 200 characters).
CCG v1.0 | CRF v1.3
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