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This is a phase II study to evaluate the efficacy and safety of TG-0054 combined with G-CSF in mobilizing hematopoietic stem cells in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TG-0054 combined with G-CSF | Experimental | 1. G-CSF: 10 μg/kg/day, administrated via SC injections from Day 1 to Day 8; 2. TG-0054: 3.14 mg/kg, administrated via 15-min IV infusion from Day 5 to Day 9 as needed to reach the target collection goal |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TG-0054 combined with G-CSF | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients From Whom a Total Number of CD34+ Cells ≥5.0 x 10^6 Cells/kg Was Collected Within the First 4 Leukapheresis Sessions | The primary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥5.0 x 10^6 cells/kg was collected within the first 4 leukapheresis sessions. For the primary efficacy endpoint, each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) the first 4 leukapheresis sessions. | Day 5 to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients From Whom a Total Number of CD34+ Cells ≥2.5 x 10^6 Cells/kg Was Collected Within the First 4 Leukapheresis Sessions | The secondary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥2.5 x 10^6 cells/kg was collected within the first 4 leukapheresis sessions. Each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) the first 4 leukapheresis sessions. |
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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*10^9/L on screening laboratory assessments;
Absolute neutrophil count ≧ 1.5*10^9/L on screening laboratory assessments;
Platelet count ≧ 100*10^9/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 M Schuster, MD | Stony Brook University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States | ||
| Tennessee Oncology, PLLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41636886 | Derived | Sukhtankar DD, Cardarelli PM, Jalilizeinali B, Setia G, Kim G, Chang LW, Tsai CY, Caculitan NG, Schuster MW. Burixafor, a CXCR4 inhibitor with a differentiated kinetics profile: results of a phase 2 study for rapid cell mobilization in multiple myeloma and lymphoma patients undergoing transplant. Ann Hematol. 2026 Feb 4;105(3):86. doi: 10.1007/s00277-026-06858-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TG-0054 Combined With G-CSF | 1. G-CSF: 10 μg/kg/day, administrated via SC injections from Day 1 to Day 8; 2. TG-0054: 3.14 mg/kg, administrated via 15-min IV infusion from Day 5 to Day 9 as needed to reach the target collection goal. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Day 5 to Day 8 |
| Proportion of Patients Who Mobilized the Targeted Total Number of CD34+ Cells (≥6.0 x 10^6 Cells/kg) Within 5 Leukapheresis Sessions | The secondary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥6.0 x 10^6 cells/kg was collected within 5 leukapheresis sessions. Each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) 5 leukapheresis sessions. | Day 5 to Day 9 |
| the Pharmacodynamics (PD) Following Treatment With TG-0054 When Combined With G-CSF | determine circulating CD34+ cell counts in peripheral blood | Day 5 (1st leukapheresis session) to Day 6 (2nd leukapheresis session) |
| Nashville |
| Tennessee |
| 37203 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TG-0054 Combined With G-CSF | 1. G-CSF: 10 μg/kg/day, administrated via SC injections from Day 1 to Day 8; 2. TG-0054: 3.14 mg/kg, administrated via 15-min IV infusion from Day 5 to Day 9 as needed to reach the target collection goal. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Weight | Mean | Full Range | kg |
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| BMI | Mean | Full Range | kg/m^2 |
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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 | Proportion of Patients From Whom a Total Number of CD34+ Cells ≥5.0 x 10^6 Cells/kg Was Collected Within the First 4 Leukapheresis Sessions | The primary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥5.0 x 10^6 cells/kg was collected within the first 4 leukapheresis sessions. For the primary efficacy endpoint, each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) the first 4 leukapheresis sessions. | There were total 9 MM patients and 3 NHL or HD patients . A MM patient was treated with Revlimid, Following 2 leukapheresis sessions, a cumulative total of 0.18 x 10^6 cells/kg were collected. PI and Medical Monitor didn't feel that further leukapheresis sessions would achieve more cells, so the patient didn't have additional sessions. | Posted | Number | 95% Confidence Interval | Proportion of participants | Day 5 to Day 8 |
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| Secondary | Proportion of Patients From Whom a Total Number of CD34+ Cells ≥2.5 x 10^6 Cells/kg Was Collected Within the First 4 Leukapheresis Sessions | The secondary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥2.5 x 10^6 cells/kg was collected within the first 4 leukapheresis sessions. Each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) the first 4 leukapheresis sessions. | There were total 9 MM patients and 3 NHL or HD patients . A MM patient was treated with Revlimid, Following 2 leukapheresis sessions, a cumulative total of 0.18 x 10^6 cells/kg were collected. PI and Medical Monitor didn't feel that further leukapheresis sessions would achieve more cells, so the patient didn't have additional sessions. | Posted | Number | 95% Confidence Interval | Proportion of patients | Day 5 to Day 8 |
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| Secondary | Proportion of Patients Who Mobilized the Targeted Total Number of CD34+ Cells (≥6.0 x 10^6 Cells/kg) Within 5 Leukapheresis Sessions | The secondary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥6.0 x 10^6 cells/kg was collected within 5 leukapheresis sessions. Each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) 5 leukapheresis sessions. | There were total 9 MM patients and 3 NHL or HD patients . A MM patient was treated with Revlimid, Following 2 leukapheresis sessions, a cumulative total of 0.18 x 10^6 cells/kg were collected. PI and Medical Monitor didn't feel that further leukapheresis sessions would achieve more cells, so the patient didn't have additional sessions. | Posted | Number | 95% Confidence Interval | Proportion of patients | Day 5 to Day 9 |
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| Secondary | the Pharmacodynamics (PD) Following Treatment With TG-0054 When Combined With G-CSF | determine circulating CD34+ cell counts in peripheral blood | There were 5 patients who achived target number of CD34+ cells (>=5.0*10^6 cells/kg) within two leukapheresis sessions and therefore didn't undergo addtional sessions. Among 7 patients who undergone 6 sessions, there were 1 patient didn't collect blood sample at 4h, 6h post-infusion and post-leukapheresis, and 1 patient 6h post-infusion not done. | Posted | Median | Full Range | cells/µL | Day 5 (1st leukapheresis session) to Day 6 (2nd leukapheresis session) |
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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 | 10 µg/kg/Day G-CSF Alone | Days 1 through 4 | 0 | 12 | 0 | 12 | 2 | 12 |
| EG001 | 10 µg/kg/Day G-CSF + 3.14 mg/kg TG-0054 | Day 5 until end of study | 0 | 12 | 0 | 12 | 6 | 12 |
| EG002 | Overall | 0 | 12 | 0 | 12 | 7 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypocalcaemia | Metabolism and nutrition disorders |
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| Bone pain | Musculoskeletal and connective tissue disorders |
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| Diarrhoea | Gastrointestinal disorders |
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| Dry mouth | Gastrointestinal disorders |
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| Nausea | Gastrointestinal disorders |
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| Hypokalaemia | Metabolism and nutrition disorders |
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| Oedema peripheral | General disorders |
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| Platelet count decreased | Investigations |
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| Paraesthesia | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Li-Wen Chang | TaiGen Biotechnology Co., Ltd. | +886-2-8177-7072 | 1227 | lwchang@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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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Multiple Myeloma |
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| Non-Hodgkin Lymphoma or Hodgkin Disease |
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| OG003 | Within 4 Leukapheresis Sessions | Cumulative CD34+ cell counts ≥5.0 x 10^6 cells/kg within 4 leukapheresis session |
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| OG003 | Within 4 Leukapheresis Sessions | Cumulative CD34+ cell counts ≥6.0 x 10^6 cells/kg within 4 leukapheresis session |
| OG004 | Within 5 Leukapheresis Sessions | Cumulative CD34+ cell counts ≥6.0 x 10^6 cells/kg within 5 leukapheresis session |
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Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at Pre-leukapheresis timepoint
| OG004 | Post-leukapheresis | Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at Post-leukapheresis timepoint |
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| Title | Measurements |
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