GTP Scenario # 3GTP Scenario # 3

September 17,2005September 17,2005

Scenario # 3Scenario # 3

A donor is to donate A donor is to donate lymphocyteslymphocytes to a to a siblingsibling 1 year after having been the PBPC 1 year after having been the PBPC donor.donor.

7 Days before donation ID testing is 7 Days before donation ID testing is performed (performed (all results negative/NRall results negative/NR). The ). The donor is evaluated and deemed ‘donor is evaluated and deemed ‘eligibleeligible’.’.

On the scheduled day of donation, the On the scheduled day of donation, the donor cannot travel to the apheresis unit donor cannot travel to the apheresis unit due to weather conditions. due to weather conditions.

The collection is scheduled for the next day The collection is scheduled for the next day ((8 days8 days after the collection of the ID blood after the collection of the ID blood sample).sample).

What needs to be done to administer the What needs to be done to administer the DLI shortly after collection?DLI shortly after collection?

What should be considered?What should be considered?

Does release of this product Does release of this product meet the definition of “Urgent meet the definition of “Urgent Medical Need” as defined in 21 Medical Need” as defined in 21 CFR1271.3 (u)?CFR1271.3 (u)? Is there no comparable HCT/P Is there no comparable HCT/P

available?available? Would the recipient suffer death or Would the recipient suffer death or

serious morbidity without the serious morbidity without the product?product?

What should be considered?What should be considered? Does release of this product meet Does release of this product meet

the definition of “Urgent Medical the definition of “Urgent Medical Need”? Need”? YesYes No comparable HCT/P available?No comparable HCT/P available?

TrueTrue Recipient likely to suffer death or Recipient likely to suffer death or

serious morbidity without the serious morbidity without the product?product?

TrueTrue

What Documents Are What Documents Are Required?Required?

Urgent Medical Need FormUrgent Medical Need Form Includes notification of the Includes notification of the

recipient’s physicianrecipient’s physician Recipient ConsentRecipient Consent

Follow-UpFollow-Up

Do the infectious disease tests Do the infectious disease tests need to be repeated?need to be repeated?

Yes 1271.60(d)Yes 1271.60(d)

Must the results be available Must the results be available prior to release of the product?prior to release of the product?

Not if Urgent Medical Need Not if Urgent Medical Need documentation is obtained.documentation is obtained.

VariationVariation

What would be different if this What would be different if this product were intended for product were intended for cryopreservation and cryopreservation and administration 3 weeks later?administration 3 weeks later?

Collect repeat ID samples on Collect repeat ID samples on the day of collection and then the day of collection and then the results would be available the results would be available prior to administration. Not an prior to administration. Not an urgent medical need situation.urgent medical need situation.