Department of Medicine, Division of Oncology, Washington University School of Medicine, St. Louis, MO 63108, USA.
BioLineRx, Ltd, Modi'in, Israel.
Future Oncol. 2019 Nov;15(31):3555-3563. doi: 10.2217/fon-2019-0380. Epub 2019 Sep 9.
Effective hematopoietic cell transplantation relies upon collecting adequate numbers of CD34 hematopoietic stem cells, typically from peripheral blood. A minimum of ≥2 × 10 CD34 cells/kg are necessary, while transplants of ≥5-6 × 10 CD34 cells/kg are associated with improved hematopoietic recovery. Granulocyte colony stimulating factor (G-CSF) remains the gold standard for hematopoietic stem cell mobilization. However, in randomized trials for autologous-hematopoietic cell transplantation in multiple myeloma, approximately 45% of patients remain unable to optimally mobilize with G-CSF alone despite multiple injections and apheresis days. Therefore, reducing mobilization failures remains an unmet need. The study objective is to evaluate the superiority of one dose of BL-8040 plus G-CSF over placebo plus G-CSF to mobilize ≥6.0 × 10 CD34 cells/kg in up to two apheresis days. ClinicalTrials.gov: NCT03246529.
有效的造血细胞移植依赖于采集足够数量的 CD34 造血干细胞，通常来自外周血。需要至少≥2×10 CD34 细胞/kg，而≥5-6×10 CD34 细胞/kg 的移植与造血恢复的改善相关。粒细胞集落刺激因子（G-CSF）仍然是造血干细胞动员的金标准。然而，在多发性骨髓瘤的自体造血细胞移植的随机试验中，尽管多次注射和单采天数，仍有约 45%的患者不能单独用 G-CSF 进行最佳动员。因此，减少动员失败仍然是一个未满足的需求。本研究的目的是评估单次 BL-8040 加 G-CSF 与安慰剂加 G-CSF 相比，在最多两次单采日中动员≥6.0×10 CD34 细胞/kg 的优越性。ClinicalTrials.gov：NCT03246529。
