| Title | Safety, Efficacy, Pharmacokinetic and Pharmacodynamic evaluation of YF-H-2015005 for mobilizing Hematopoietic stem cells in Non-Hodgkin's Lymphoma Patients |
| Authors | Liu, Weiping Xie, Yan Ping, Lingyan Jiang, Min Zhang, Guanmin Cui, Yimin Xu, Junyu Wu, Meng Leng, Xin Wang, Xiaopei Wang, Shufang Zhu, Jun Song, Yuqin |
| Affiliation | Peking Univ, Dept Lymphoma, Key Lab Carcinogenesis & Translat Res, Minist Educ,Canc Hosp & Inst, 52 Fucheng Rd, Beijing 100142, Peoples R China Peking Univ, Natl Drug Clin Trial Ctr, Key Lab Carcinogenesis & Translat Res, Minist Educ,Canc Hosp & Inst,GCP Ctr, 52 Fucheng Rd, Beijing 100142, Peoples R China Peking Univ, Dept Pharm, Key Lab Carcinogenesis & Translat Res, Minist Educ,Canc Hosp & Inst, 52 Fucheng Rd, Beijing 100142, Peoples R China Peking Univ, Dept Pharm, Hosp 1, 8 Xishiku St, Beijing 100034, Peoples R China Hefei Yifan Biopharmaceut Inc, Intersect Jinxiu Ave & Qinglongtan Rd, Hefei 610000, Peoples R China |
| Keywords | PERIPHERAL-BLOOD MULTIPLE-MYELOMA MOBILIZATION TRANSPLANTATION PLERIXAFOR COLLECTION STATEMENT AMD3100 |
| Issue Date | 2020 |
| Publisher | JOURNAL OF CANCER |
| Abstract | Background: Targeting the interaction between SDF1 and CXCR4 may provide an opportunity to intervene in the hematopoietic stem cell mobilization process. Aim: The present study aimed to investigate the safety, efficacy, pharmacokinetic and pharmacodynamic profiles of YF-H-2015005, a CXCR4 antagonist, for the mobilization of hematopoietic stem cells (HSCs). Methods: A total of 15 patients with non-Hodgkin's lymphoma (NHL) eligible for autologous hematopoietic stem cell transplantation were enrolled. All patients achieved a partial or complete remission after the first- or second-line therapy. Granulocyte colony stimulating factor (G-CSF) was given in the morning for 8 consecutive days, and 0.24 mg/kg YF-H-2015005 was subcutaneously administered in the evening of the 4th day of G-CSF treatment for up to four days. Apheresis was performed 9-10 hours following each dose of YF-H-2015005. Results: YF-H-2015005 was rapidly absorbed and eliminated, with T-max and t(1/2) of 0.5 and 5.04 +/- 1.00 hours, respectively. Moreover, the mean peripheral blood CD34(+) cell counts were elevated by 2.0- to 2.9-fold from 2 to 24 hours, and reached the maximum level of 76.5 +/- 53.9 cells/kg at 10 hours after YF-H-2015005 treatment. Fourteen (93%) out of 15 NHL patients achieved a minimum target of >= 2x10(6)/kg CD34(+) cells. Furthermore, there was no grades 3-4 treatment-related adverse event observed among these patients. Conclusion: YF-H-2015005 can serve as a safe, effective agent in combination with G-CSF for CD34(+) hematopoietic progenitor cell mobilization in NHL patients. |
| URI | http://hdl.handle.net/20.500.11897/590757 |
| ISSN | 1837-9664 |
| DOI | 10.7150/jca.48748 |
| Indexed | SCI(E) |
| Appears in Collections: | 北京肿瘤医院 第一医院 |
