A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease
|ClinicalTrials.gov Identifier: NCT01458288|
Recruitment Status : Completed
First Posted : October 24, 2011
Results First Posted : January 8, 2015
Last Update Posted : January 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Non-hodgkin's Lymphoma Hodgkin's Disease||Drug: TG-0054||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Experimental: TG-0054 (3.14 mg/kg)
TG-0054 (3.14 mg/kg)
3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)
Other Name: burixafor
- Number of Patients Achieving the CD34+ Hematopoietic Stem Cell (HSC) Mobilization Target of ≧2.5×1000000 Cells/kg [ Time Frame: 1 week ]
Patients were all with multiple myeloma (MM), Non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD).
Number of patients who mobilized the targeted total number of CD34+ cells within a maximum of 4 leukapheresis sessions in study arm 1 and arm 3. Patients in arm 1 followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1. Patients in arm 3 followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.
- the Average Number of Leukapheresis Sessions [ Time Frame: 1 week ]To determine the average number of leukapheresis sessions required to collect 2.5 x106 CD34+ cells/kg.
- the Safety of TG-0054 in Patients With MM, NHL or HD [ Time Frame: 1 month ]To evaluate the safety of TG-0054 in patients with MM, NHL or HD All adverse events will be coded according to the MedDRA dictionary, and be limited to events related or not related to study drug.
- the Pharmacodynamics (PD) of TG-0054 [ Time Frame: pre-dose(-2 to 0 h),2, 4 and 6 hr after dosing. ]To evaluate the pharmacodynamics (PD) of TG-0054 by determining circulating CD34+ cell counts in peripheral blood.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458288
|United States, New York|
|Stony Brook University Hospital|
|Stony Brook, New York, United States, 11794|
|Principal Investigator:||Michael W. Schuster, M.D.||Stony Brook University Hospital|