A randomized clinical trial comparing @entity1261 administration sites for mobilization of peripheral blood stem cells for XXXX with hematologic malignancies undergoing autologous stem cell transplantation.

@entity1 @entity1261 @entity706 @entity1582 @entity2280
BACKGROUND: A study was undertaken to investigate whether @entity1261 ( @entity1261 ) injection in lower adipose tissue-containing sites (arms and legs) would result in a lower exposure and reduced stem cell collection efficiency compared with injection into abdominal skin. STUDY DESIGN AND METHODS: We completed a prospective randomized study to determine the efficacy and tolerability of different injection sites for @entity1 with multiple @entity1582 or @entity706 undergoing stem cell mobilization and apheresis. Primary endpoints were the number of @entity2280 + cells collected and the number of days of apheresis. Forty @entity1 were randomly assigned to receive cytokine injections in their abdomen (Group A) or extremities (Group B). Randomization was stratified based on diagnosis ( @entity1582 , n=29 vs. @entity706 , n=11), age, and mobilization strategy and balanced across demographic factors and body mass index. RESULTS: Thirty-five subjects were evaluable for the primary endpoint: 18 in Group A and 17 in Group B. One evaluable subject in each group failed to collect a minimum dose of at least 2.0*10(6) @entity2280 + cells/kg. The mean numbers of @entity2280 + cells (  SD) collected were not different between Groups A and B (9.15*10(6)  4.7*10(6) /kg vs. 9.85*10(6)   5*10(6) /kg, respectively; p=NS) after a median of 2 days of apheresis. Adverse events were not different between the two groups. CONCLUSION: The site of @entity1261 administration does not affect the number of @entity2280 + cells collected by apheresis or the duration of apheresis needed to reach the target cell dose.
