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
This study has been completed.
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.
First received: October 13, 2011
Last updated: December 25, 2014
Last verified: December 2014
This Phase II study is 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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Outcome Measures:
- Number of Patients Achieving the CD34+ Hematopoietic Stem Cell (HSC) Mobilization Target of ≧2.5×1000000 Cells/kg [ Time Frame: 1 week ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- the Average Number of Leukapheresis Sessions [ Time Frame: 1 week ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: No ]
To evaluate the pharmacodynamics (PD) of TG-0054 by determining circulating CD34+ cell counts in peripheral blood.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2013 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years to 75 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Received radiation therapy to the pelvis;
- Received > 6 cycles of lenalidomide;
- Evidence of bone marrow involvement of lymphoma in NHL patients;
- Failed previous stem cell collection [failed to collect 2 x 106 CD34+ cells/kg within 4 leukapheresis sessions after receiving granulocyte colony-stimulating factor (G-CSF)];
- Patients who have undergone previous stem cell transplantation procedure;
- Received G-CSF within 2 weeks prior to the study drug administration;
- History of other cancer within the past 5 years excluding MM, NHL, HD, basal cell or squamous cell carcinoma of the skin;
- History of other hematologic disorders including bleeding or thromboembolic disease being treated with anti-coagulant;
- History of poor and uncontrollable cardiovascular or pulmonary disease such as myocardial infarction, cardiac arrhythmias, transient ischemic attack, stroke or Chronic Obstructive Pulmonary Disease (COPD) patients hospitalized more than two times a year due to underlying disease;
- Diagnosis of sickle cell anemia or documented sickle cell trait;
- Patients with proliferative retinopathy;
- Uncontrollable malignancy with MM, NHL or HD, or carcinomatous meningitis, at Investigator's discretion;
- Any infection required antibiotic treatment or unexplained fever above 38 °C within 3 days prior to dosing;
- Pregnant or breast-feeding;
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study;
- Received any other investigational drug within 1 month before entering the study;
- Received prior treatment with TG-0054 but withdrew early from this study.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01458288
|Stony Brook University Hospital
|Stony Brook, New York, United States, 11794 |
TaiGen Biotechnology Co., Ltd.
||Michael W. Schuster, M.D.
||Stony Brook University Hospital
||TaiGen Biotechnology Co., Ltd.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 13, 2011
|Results First Received:
||December 16, 2014
||December 25, 2014
||United States: Food and Drug Administration
Taiwan: Department of Health
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 25, 2016
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Immune System Diseases
Blood Protein Disorders