NCT02104427已完成2 期
A Phase II, Open-Label Study to Evaluate the Hematopoietic Stem Cell Mobilization of TG-0054 Combined With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •At least one year post-menopausal, or
- •Surgically sterile, or
- •Willing to use a double-barrier method [intrauterine device (IUD) plus condom, spermicidal gel plus condom] of contraception from study Day 1 until 28 days after the last dose of TG-0054;
- •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.
排除标准
- •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 2.0*10^6 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.
研究组 & 干预措施
TG-0054 combined with G-CSF
Experimental
- 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
干预措施: TG-0054 combined with G-CSF (Drug)
结局指标
主要结局
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
时间窗: Day 5 to Day 8
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.
次要结局
- Proportion of Patients Who Mobilized the Targeted Total Number of CD34+ Cells (≥6.0 x 10^6 Cells/kg) Within 5 Leukapheresis Sessions(Day 5 to Day 9)
- 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(Day 5 to Day 8)
- the Pharmacodynamics (PD) Following Treatment With TG-0054 When Combined With G-CSF(Day 5 (1st leukapheresis session) to Day 6 (2nd leukapheresis session))
研究者
研究点 (2)
Loading locations...
相似试验
招募中
2 期
G-CSF After Chemo-radiation in Patients With GlioblastomaMGMT-Methylated GlioblastomaGlioblastoma (GBM)Newly Diagnosed Glioblastoma MultiformeNCT06649851Massachusetts General Hospital60
已完成
2 期
GM-CSF for Maintenance of Prostate Cancer for Patients Responding to TaxotereProstate CancerNCT00274287Oncology Specialists, S.C.15
已完成
2 期
Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological MalignanciesAcute Myelogenous LeukemiaNon-Hodgkin's LymphomaAcute Lymphoblastic LeukemiaNon-Hodgkin LymphomaHodgkin DiseaseHodgkins DiseaseHodgkin's DiseaseMyeloproliferative NeoplasmMultiple MyelomaMyelodysplastic SyndromeChronic Myelogenous LeukemiaNCT02639559Washington University School of Medicine50
尚未招募
1 期
A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3Human Papillomavirus Associated Intraepithelial NeoplasiaCervical Intraepithelial Neoplasia Grade 2/3Human Papillomavirus Type 16 InfectionHuman Papillomavirus Type 18 InfectionNCT06273553RinuaGene Biotechnology Co., Ltd.39
已完成
2 期
Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis BChronic HBV InfectionNCT01943799Gilead Sciences178