Plerixafor Plus Granulocyte Colony-Stimulating Factor For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Non-Hodgkin Lymphoma

Summary

Primary Objective: To determine if non-Hodgkin Lymphoma (NHL) participants mobilized with granulocyte colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of greater than or equal to 5 x 10\^6 cluster differential (CD) 34+ cells/kg in 4 or fewer days of apheresis than NHL participants mobilized with G-CSF alone. Secondary Objectives: * To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in NHL participants. * To compare the 2 treatment arms with respect to the number of participants who achieved a minimum of 2 x 10\^6 CD34+ cells/kg in 4 or fewer days of apheresis. * To compare the 2 treatment arms with respect to the number of days of apheresis required to reach the target of greater than or equal to 5 x 10\^6 CD34+ cells/kg.

Timeline

Start

2014-11

Primary completion

2016-03

Completion

2016-03

Publications

• Matsue K, Kumagai K, Sugiura I, Ishikawa T, Igarashi T, Sato T, Uchiyama M, Miyamoto T, Ono T, Ueda Y, Kiguchi T, Sunaga Y, Sasaki T, Suzuki K. Plerixafor for mobilization and collection of haematopoietic stem cells for autologous transplantation in Japanese patients with non-Hodgkin lymphoma: a randomized phase 2 study. Int J Hematol. 2018 Nov;108(5):524-534. doi: 10.1007/s12185-018-2505-4. Epub 2018 Jul 24.

Drugs

Indications