Off Protocol

*The timeline requirements for this form are as follows:
Assessment Time Frame: At the time of study completion or study exit. 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.
Submission Time Frame: Within 14 days of a qualifying event per protocol section 6.6.1.

The Off Protocol CRF is a common form, which is available at the bottom of the subject’s page in EDC. This CRF will only be completed if the subject experiences a qualifying event per protocol section 6.6.1. If subject completes the study (defined as completing the Day +365 visit) without experiencing an off protocol event, leave this CRF blank.

!Off-protocol subjects are followed for limited clinical endpoint data listed in Table 6 of the protocol. Off-protocol patients will be followed for serious adverse events for a 30-day safety follow-up period, unless the end of study comes first. Please reference the ISA for specific guidance.

No other study-specific evaluations, procedures, or tests outside of standard of care will be performed or collected after the date a subject is considered off-protocol. If more than one off-protocol criterion is met, the earliest off-protocol qualifying event will be considered the off-protocol date.

Subjects who are considered off-protocol will be followed until they (a) complete the final follow-up time point or (b) meet criteria for early termination.

Please ensure any data collected between visits, up to the date off protocol, is logged on the next visit’s CRFs. This includes:

• Hematopoietic Recovery / Primary Graft Failure – Day 28 CRF: Please complete this CRF up to the time of off protocol, if D28 has not yet occurred (data is critical to study endpoints).
• Hematopoietic Recovery – Day 56, Day 100 CRF: Please complete this CRF up to the time of off protocol, if D56 or D100 have not yet occurred.
• Follow-Up Assessment CRFs: GVHD, DLI/DCI, VOD, any post-transplant maintenance therapy, graft failure, disease relapse or progression

Date subject off protocol:
Enter the date the subject came off protocol in DD/MMM/YYYY format. This will align with the earliest off-protocol qualifying event, per protocol section 6.6.1 OFF-PROTOCOL FOLLOW-UP. Please see protocol for limited data collection guidance once expected for subjects off protocol. If subject experienced multiple off-protocol qualifying events, this will be reported in final field on the CRF.

Why was the patient taken off protocol:
Indicate the reason the subject came off protocol from the options below. This should align with the earliest off-protocol qualifying event.
• Subject received a subsequent HCT*
• Subject experienced disease relapse or progression**
• Other

.* Subsequent transplants must also be reported on the Follow-Up Assessment CRF. Date subject off protocol will reflect the date of start of conditioning for subsequent HCT.

.** Relapse must also be reported on the Follow-Up Assessment CRF and Relapse / Progression CRF (which populates after relapse is reported on the Follow-Up Assessment CRF). Date subject off protocol will reflect the date of clinically confirmed disease relapse. Subject remains on study for limited data collection, per protocol section 6.6.1. Do not complete the Study Exit / Study Completion CRF until subject completes the study (completes D365 visit) OR until an event qualifying for early termination occurs (per protocol section 6.6.2).

If other, specify:
This field will only appear in the EDC if “Why was the patient taken off protocol” is answered Other. Describe the off-protocol qualifying event in the free textbox (up to 200 characters).

Describe why patient was taken off protocol:
Describe any off-protocol qualifying event(s) the subject has experienced in the free textbox (up to 200 characters).

CCG v1.0 | CRF v1.3

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