GTP Scenario # 3 September 17,2005

Scenario # 3 A donor is to donate lymphocytes to a sibling 1 year after having been the PBPC donor. A donor is to donate lymphocytes to a sibling 1 year after having been the PBPC donor. 7 Days before donation ID testing is performed (all results negative/NR). The donor is evaluated and deemed ‘eligible’. 7 Days before donation ID testing is performed (all results negative/NR). The donor is evaluated and deemed ‘eligible’. On the scheduled day of donation, the donor cannot travel to the apheresis unit due to weather conditions. On the scheduled day of donation, the donor cannot travel to the apheresis unit due to weather conditions. The collection is scheduled for the next day (8 days after the collection of the ID blood sample). The collection is scheduled for the next day (8 days after the collection of the ID blood sample). What needs to be done to administer the DLI shortly after collection? What needs to be done to administer the DLI shortly after collection?

What should be considered? Does release of this product meet the definition of “Urgent Medical Need” as defined in 21 CFR (u)? Does release of this product meet the definition of “Urgent Medical Need” as defined in 21 CFR (u)? Is there no comparable HCT/P available? Is there no comparable HCT/P available? Would the recipient suffer death or serious morbidity without the product? Would the recipient suffer death or serious morbidity without the product?

What should be considered? Does release of this product meet the definition of “Urgent Medical Need”? Does release of this product meet the definition of “Urgent Medical Need”?Yes No comparable HCT/P available? No comparable HCT/P available? True True Recipient likely to suffer death or serious morbidity without the product? Recipient likely to suffer death or serious morbidity without the product?True

What Documents Are Required? Urgent Medical Need Form Urgent Medical Need Form Includes notification of the recipient’s physician Includes notification of the recipient’s physician Recipient Consent Recipient Consent

Follow-Up Do the infectious disease tests need to be repeated? Do the infectious disease tests need to be repeated? Yes (d) Must the results be available prior to release of the product? Must the results be available prior to release of the product? Not if Urgent Medical Need documentation is obtained.

Variation What would be different if this product were intended for cryopreservation and administration 3 weeks later? What would be different if this product were intended for cryopreservation and administration 3 weeks later? Collect repeat ID samples on the day of collection and then the results would be available prior to administration. Not an urgent medical need situation. Collect repeat ID samples on the day of collection and then the results would be available prior to administration. Not an urgent medical need situation.