IMPACT OF A DATA-DRIVEN PREDICTION ALGORITHM FOR BLOOD VOLUME PROCESSING IN PERIPHERAL BLOOD STEM CELL COLLECTION IN UNRELATED (NMDP) HPC DONORS

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1 IMPACT OF A DATA-DRIVEN PREDICTION ALGORITHM FOR BLOOD VOLUME PROCESSING IN PERIPHERAL BLOOD STEM CELL COLLECTION IN UNRELATED (NMDP) HPC DONORS Anand Padmanabhan, MD PhD QIA BloodCenter of Wisconsin Milwaukee, Wisconsin ASFA Annual Meeting 2017 Ft. Lauderdale, Florida

2 Disclosures Name Institution Disclosure Anand Padmanabhan, MBBS MA PhD BloodCenter of Wisconsin Terumo BCT, Mallinckrodt Pharmaceuticals, Schlesinger Associates, LEK Consulting, Angiodynamics, BCW 2

3 Background An important source of stem cells for hematopoietic stem cell transplantation (HSCT) is peripheral blood (PB) Hematopoietic stem cells (HPCs) are collected for HCSTs using large volume leukapheresis (LVL) that typically involves processing >4 blood volumes to ensure adequate collection of HPCs

4 Background Large volume leukapheresis of NMDP donors is time-intensive, causes volume overload, hypocalcemia and platelet depletion. We performed a quality improvement study to generate a collection efficiency-based, data-driven algorithm for HPC collection to predict the required volume of donor blood to process in order to meet a CD34+ target. We then prospectively assessed the efficacy of the predictive model in NMDP donors

5 Methods Collection Device: Cobe Spectra & Spectra Optia Anticoagulant: ACD-A/Heparin 11 unit/ml Single day collections are standard Donor blood processed: 24L (Before truncation algorithm) After predicted algorithm initiated Terminate collection when CD34 goal is estimated to be achieved Pre-collection CD34 count is typically available within 2-3 hours of starting collection

6 Methods We evaluated the CD34+ cellular collection efficiency 2 (CE2) in consecutive adult allogeneic (A-allo) collections ( training set ) CE2= CD34 cells collected/(bvp x precollection CD34 count) Mean (1SD) CD34 CE2s (N): A-allo- 51% (14%)- 59 donors

7 Methods Prediction of Blood Volume to be Processed (BVP) was calculated as follows: BVP = CD34 cell target CD34 CE2 x Precollection PB CD34 Count

8 Methods In order to have a high level of confidence that the targeted dose of cells is collected, the CD34 CE2 in the prediction formula was set at: 30% (lowest CE2 attained in allo patients in the training set )

9 Results Performance of the prediction formula was evaluated in HPC collections in NMDP donors over 6 months

10 Truncation vs Pre Truncation Era: Donors age was similar n=12 n=14

11 Truncation vs Pre Truncation Era: Donors similarly mobilized n=12 n=14

12 Results Procedures truncated in the 6 month period: 8 of 14 = 57%

13 BVP: Significantly smaller in truncated procedures

14 Significantly fewer platelets depleted in truncated procedures

15 Better Mobilized patients more likely to be truncated

16 CD34 Yield All truncated collections resulted in adequate collection of CD34 cells (> target dose requested) 1

17 Current Process: Prediction 2.0 Now we use 42% CE2 in our prediction algorithm A minimum of 10L is processed currently, even if the truncation prediction suggests <10L

18 Conclusion A high % of NMDP collections were truncated using our prediction algorithm Lesser platelet depletion in truncated donors As expected, truncation was recommended in donors more likely to be better mobilized

19 Conclusion No prediction failures thus far The volume of BVP truncated was significantly lower (~by 9L on average) compared to non-truncated procedures We are continuing to implement algorithm in all referred NMDP donors

20 Conclusion This approach may be particularly important in mitigating risks of LVL such as volume overload/citrate toxicity and promoting optimal use of healthcare resources and enhances donor convenience and satisfaction

21 Acknowledgments BloodCenter of Wisconsin: - Kenneth Friedman - Sorelle Jefcik - Jean Wucinski - Lori Eggert - Patricia Fredrich - BCW Apheresis RNs Medical College of Wisconsin: - Carolyn Keever-Taylor - David Margolis - Parameswaran Hari - Volunteer PBSC donors