To access follow-up visit CRFs, click on the Enter Date box and enter the date of the current study visit. Click Save. If the date entered is a future date, a query will appear in the EDC. Prior study visit date must be entered OR Did Not Occur should be selected.
Date of Evaluation:
Report the date of this study visit in DD/MMM/YYYY format. The visit windows are outlined at the top of this page.
If conducted out of window, a protocol deviation should be logged in the EDC.
Survival Status:
Report the subject’s most current survival status as Alive or Deceased.
If Deceased, also please confirm that the subject has been exited from the study via completion of the Study Exit / Study Completion CRF.
Please also complete an Adverse Event form reporting the event that resulted in death. See the Adverse Event and Study Exit / Study Completion reporting sections and the platform protocol section 8.7 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS for more details on reporting a subject death and adverse events that resulted in death.
Subject Status:
Select the subject status as:
• Per Protocol
• Off-protocol due to disease relapse or progression
• Off-protocol due to subsequent transplant
The subsequent fields will come due based on answers to Subject Status.
Were AEs and concomitant medications assessed per protocol at this visit?:
This field appears when Subject Status is answered Per Protocol. Report if AEs and concomitant medications assessed per protocol at this visit as “Yes” or “No.”
Was infectious disease assessment completed since last reported for study:
This field appears when Subject Status is answered Per Protocol or Off-Protocol due to disease relapse or progression. Report if an infectious disease assessment was completed within the visit window. Infectious disease monitoring will occur per institutional standards.
If not performed, a protocol deviation should be logged in the EDC.
Was there evidence of infection since last reported for study:
This field will only appear in EDC if “Was infectious disease assessment completed since last reported for study” is answered Yes. Indicate if there was evidence of infection since last reported for this study (and if so, the maximum observed grade):
• Yes, maximum BMT CTN Grade 1
• Yes, maximum BMT CTN Grade 2 or 3
• No
If a maximum grade of 2 or 3 is observed, please ensure BMT CTN Grade 2 or 3 infection is reported on the Infection CRF. Refer to protocol Appendix D – BMT CTN Infection Grading Criteria for more information.
Reason why infection assessment not completed at this timepoint:
This field will only appear in EDC if “Was infectious disease assessment completed since last reported” is answered No. Please report the reason infection monitoring was not completed per protocol in this free textbox (up to 200 characters).
Was viral testing for CMV completed since last reported for study:
This field appears when Subject Status is answered Per Protocol or Off-Protocol due to disease relapse or progression. Report if cytomegalovirus (CMV) testing by plasma PCR was completed within the visit window. CMV monitoring will be done according to institutional guidelines. It is recommended that weekly assessments for CMV DNAemia be done through at least Day +56 post-transplant (longer if continued immunosuppression use, previous DNAemia, or active GvHD). Any reactivation and/or CMV disease will be captured in this study, including beyond Day +56.
If not performed, a protocol deviation should be logged in the EDC.
Is there evidence of CMV reactivation or infection post-transplant since last reported for study:
This field will only appear in EDC if “Was viral testing for CMV completed since last reported” is answered Yes. Indicate if there was any cytomegalovirus (CMV) activity identified through PCR testing since last reported for this study. CMV reactivation is defined as the presence of CMV in blood according to World Health Organization (WHO) International Standard (>150 copies/mL) in patients who were DNA negative prior to HCT.
• Yes
• No
Reason why CMV assessment not completed:
This field will only appear in EDC if “Was viral testing for CMV completed since last reported” is answered No. Please report the reason CMV monitoring was not completed per protocol in this free textbox (up to 200 characters).
Was viral testing for EBV completed since last reported for study:
This field appears when Subject Status is answered Per Protocol or Off-Protocol due to disease relapse or progression. Report if Epstein–Barr virus (EBV) testing by plasma PCR was completed within the visit window. EBV monitoring will be done according to institutional guidelines.
If not performed, a protocol deviation should be logged in the EDC.
Is there evidence of EBV reactivation or infection post-transplant since last reported for study:
This field will only appear in EDC if “Was viral testing for EBV completed since last reported for study” is answered Yes. Indicate if there was any Epstein–Barr virus (EBV) activity identified through PCR testing since last reported for this study. EBV reactivation is defined as the presence of EBV in blood according to World Health Organization (WHO) International Standard (>150 copies/mL) in patients who were DNA negative prior to HCT.
• Yes
• No
• Previously Reported
Reason why EBV assessment not completed:
This field will only appear in EDC if “Was viral testing for EBV completed since last reported for study” is answered No. Please report the reason EBV monitoring was not completed per protocol in this free textbox (up to 200 characters).
Was symptom assessment for BK hemorrhagic cystitis completed since last reported for study:
This field appears when Subject Status is answered Per Protocol or Off-Protocol due to disease relapse or progression. Report if BK hemorrhagic cystitis symptom assessment was completed within the visit window. This includes a review of clinical signs / symptoms (i.e., dysuria and lower abdominal pain, ≥ Grade II hematuria or BK polyomavirus viruria of greater than 7 log10 copies/mL). If symptoms are present, obtain BK PCR from blood and urine.
If not performed, a protocol deviation should be logged in the EDC.
Were symptoms present:
This field will only appear in EDC if “Was symptom assessment for BK hemorrhagic cystitis completed since last reported for study” is answered Yes. Report if BK hemorrhagic cystitis symptoms were present. Symptomatic BK hemorrhagic cystitis will be defined using the following triad of diagnostic criteria according to European Conference on Infections in Leukemia (ECIL) guidelines.
1) Clinical symptoms/signs of cystitis, such as dysuria and lower abdominal pain
2) Hematuria Grade II or higher
3) BK polyomavirus viruria of greater than 7 log10 copies/mL
If symptoms are present, obtain BK PCR from blood and urine.
Was blood and urine assessed for BK by plasma PCR:
This field will only appear in EDC if “Were symptoms present” is answered Yes. Report if blood and urine were sent for BK testing by plasma PCR.
Reason why blood and urine not sent for PCR:
This field will only appear in EDC if “Was blood and urine assessed for BK by plasma PCR” is answered No. Please report the reason blood and urine were not sent for testing in this free textbox (up to 200 characters).
Reason why symptom assessment for BK hemorrhagic cystitis not completed:
This field will only appear in EDC if “Was symptom assessment for BK hemorrhagic cystitis completed since last reported for study” is answered No. Please report the reason symptom assessment for BK hemorrhagic cystitis was not performed in this free textbox (up to 200 characters).
Has the disease relapsed or progressed since last visit:
This field appears when Subject Status is answered Per Protocol or Off-protocol due to Subsequent transplant. Report if disease has relapsed for progressed since last visit. Relapse is defined in Appendix C of the protocol.
Were relapse research samples collected prior to initiation of therapy to treat relapse:
This field will only appear in EDC if “Has the disease relapsed or progressed since last visit” is answered Yes. Report if relapse research samples were collected prior to initiation of therapy to treat relapse.
Did the subject receive a donor lymphocyte infusion (DLI/DCI) since last reported for the study:
This field appears when Subject Status is answered Per Protocol. Report if the subject received a donor lymphocyte infusion (DLI / DCI) within the reporting period (since the last visit).
Per protocol, institution of any therapy to treat persistent, progressive or relapsed disease, including the withdrawal of immunosuppressive therapy or donor lymphocyte infusion, will be considered evidence of relapse/progression regardless of whether the criteria described above were met.
Indication for donor lymphocyte infusion (DLI/DCI):
This field will only appear in EDC if “Did the subject receive a donor lymphocyte infusion (DLI/DCI) since last reported for the study” is answered Yes. Select the indication for donor lymphocyte infusion (DLI/DCI) from the dropdown menu.
If other, specify:
This field will only appear in EDC if “Indication for donor lymphocyte infusion (DLI/DCI)” is answered Other, specify. Please report the other indication for DLI/DCI in this free textbox (up to 200 characters).
Date of DLI/DCI:
Report the date of DLI/DCI in visit in DD/MMM/YYYY format.
Did secondary graft failure occur since the date of last report:
This field appears when Subject Status is answered Per Protocol. Report if secondary graft failure occurred within the reporting period (since the last visit). If Yes, report the date of secondary graft failure below.
Secondary graft failure is defined as initial neutrophil count recovery followed by subsequent decline in absolute neutrophil counts <500 cells/mm3, unresponsive to growth factor therapy, but cannot be explained by infection, disease relapse, or medications. Secondary graft failure is confirmed by initial whole blood or donor chimerism ≥5% declining to <5% on subsequent measurements.
Date of secondary graft failure:
This field will only appear in the EDC if “Did secondary graft failure occur since the date of last report” is answered Yes. Report the date of secondary graft failure. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
Did the subject receive a subsequent transplant since last reported for the study:
This field appears when Subject Status is answered Per Protocol or Off-Protocol due to disease relapse or progression. Report if the subject received a subsequent transplant within the reporting period (since the last visit). If Yes, complete the Off Protocol CRF which is available at the bottom of the subject’s page in EDC in the Common Forms section, indicating subsequent HCT as the off-protocol reason.
Off-protocol subjects are followed for limited data collection, but no study-specific evaluations, procedures, or tests will be performed after the date a subject is considered off-protocol. Subjects who receive a subsequent transplant will continue to be followed for data points as described in Protocol Section 6.6.1 OFF-PROTOCOL FOLLOW-UP.
Subjects who are considered off-protocol will be followed until they (a) complete the final follow-up timepoint or (b) meet criteria for early termination.
Date of subsequent transplant:
This field will only appear in the EDC if “Did the subject receive a subsequent transplant since last reported for the study” is answered Yes. Report the date of subsequent transplant. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
What was the indication for subsequent HCT:
Specify the indication for subsequent HCT from the following options:
• Graft failure/ insufficient hematopoietic recovery
• Persistent primary disease
• Recurrent primary disease
• New malignancy (including PTLD and EBV)
• Insufficient chimerism
• Other, specify
If indication is not included above, select “Other, specify” and specify below.
If other indication, specify:
This field only appears in the EDC if “What was the indication for subsequent HCT” is answered Other. Specify other indication for HCT (up to 200 characters).
Was any post-transplant maintenance therapy given to prevent relapse or progression since last reported for the study:
This field appears when Subject Status is answered Per Protocol. Report whether post-transplant maintenance therapy was administered to prevent relapse or progression within the reporting period (since last reported).
If Yes, maintenance therapy must be reported on the Concomitant Medications CRF. Refer to protocol section 7.9. Concomitant Therapy for more information.
CCG v1.0 | CRF v1.3
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