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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TG-0054 (3.14 mg/kg) | Experimental | TG-0054 (3.14 mg/kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TG-0054 | Drug | 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieving the CD34+ Hematopoietic Stem Cell (HSC) Mobilization Target of ≧2.5×1000000 Cells/kg | 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. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| the Average Number of Leukapheresis Sessions | To determine the average number of leukapheresis sessions required to collect 2.5 x10^6 CD34+ cells/kg. | 1 week |
| Circulating CD34+ Cell Count in Peripheral Blood |
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Inclusion Criteria:
Male or female 18 to 75 years of age inclusive;
Patients with confirmed pathology diagnosis of MM, NHL or HD;
Potential candidate for autologous stem cell transplantation at Investigator's discretion;
4 weeks since last cycle of chemotherapy prior to the study drug administration;
Total dose of melphalan received 200 mg in the most recent chemotherapy treatment;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Recovered from all acute toxic effects of prior chemotherapy at Investigator's discretion;
White blood cell (WBC) count 3.0 x 109/L on screening laboratory assessments;
Absolute neutrophil count 1.5 x 109/L on screening laboratory assessments;
Platelet count 100 x 109/L on screening laboratory assessments;
Serum creatinine 2.2 mg/dL on screening laboratory assessments;
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin < 2 x upper limit of normal (ULN) on screening laboratory assessments;
Negative for human immunodeficiency virus (HIV);
Adequate cardiac and pulmonary function to undergo leukapheresis at Investigator's discretion;
For females, one of the following criteria must be fulfilled:
Males must be willing to use a reliable form of contraception (use of a condom or a partner fulfilling the above criteria) from study Day 1 until 28 days after the last dose of TG-0054;
Able to provide the signed informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael W. Schuster, M.D. | Stony Brook University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
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Duration of the Study:
This study will consist of a 14-day screening period, a 2- to 11-day treatment period, and a 7-day follow-up period.
Number of Patients:
Approximately 12 treatment evaluable patients will be enrolled in this study.
Study Location: Single site in US.
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| ID | Title | Description |
|---|---|---|
| FG000 | TG-0054 (3.14 mg/kg TG-0054 Administrated Via 15-min IV Infus) | TG-0054 (3.14 mg/kg) TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Calculate the median total CD34+ cell counts across all leukapheresis sessions following TG 0054 administration alone and in combination with G-CSF mobilization in order to evaluate the pharmacodynamics (PD) of TG-0054 by determining circulating CD34+ cell counts in peripheral blood.
| pre-dose(-2 to 0 h),2, 4 and 6 hr after dosing. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion) | TG-0054 (3.14 mg/kg) TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Achieving the CD34+ Hematopoietic Stem Cell (HSC) Mobilization Target of ≧2.5×1000000 Cells/kg | 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. | Posted | Number | participants | 1 week |
|
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| ||||||||||||||||||||||||||||||
| Secondary | the Average Number of Leukapheresis Sessions | To determine the average number of leukapheresis sessions required to collect 2.5 x10^6 CD34+ cells/kg. | Posted | Mean | Standard Deviation | number of leukapheresis sessions | 1 week |
|
| ||||||||||||||||||||||||||||||
| Secondary | Circulating CD34+ Cell Count in Peripheral Blood | Calculate the median total CD34+ cell counts across all leukapheresis sessions following TG 0054 administration alone and in combination with G-CSF mobilization in order to evaluate the pharmacodynamics (PD) of TG-0054 by determining circulating CD34+ cell counts in peripheral blood. | Posted | Median | Full Range | cells/kg | pre-dose(-2 to 0 h),2, 4 and 6 hr after dosing. |
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9 months, from 23-Oct-2012 to 09-Jul-2013
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion) | TG-0054 (3.14 mg/kg) TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions) | 0 | 12 | 10 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | Non-systematic Assessment |
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| Blood pressure increased | Investigations | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | Non-systematic Assessment |
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| Platelet count decreased | Investigations | Non-systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Chest discomfort | General disorders | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chen-En Tsai, M.D., Ph.D. | TaiGen Biotechnology Co., Ltd. | +886-2-8177-7072 | 1211 | cetsai@taigenbiotech.com |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
| D008206 | Lymphatic Diseases |
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