The Impact of G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 224
- 试验地点
- 3
- 主要终点
- hematopoietic engraftment time (including granulocyte engraftment and platelet engraftment)
研究概览
简要总结
Autologous hematopoietic stem cell transplantation(auto-HSCT) plays an important role in treating hematologic malignancies. Mobilization and collection of peripheral blood stem/progenitor cells is the key to successful autologous hematopoietic stem cell transplantation. Currently mobilization regimens are not enough in increasing the yield of megakaryocytic or erythroid stem/progenitor cells, resulting in a delay of hematopoietic reconstitution of platelets and erythrocytes. IL-11 and G-CSF have a synergistic role in mobilizing peripheral blood stem cells towards megakaryocytic or erythroid stem/progenitor cells in a preclinical study. Furthermore, a single-center, small cohort, prospective clinical study that has been completed in China(ChiCTR2500100054), which showed that after five days of mobilization, the combination of G-CSF and IL-11 significantly increased the number and proportion of functional megakaryocytic/erythroid progenitor cells in the peripheral blood mononuclear cells of patients, and also significantly shortened the time for platelet engraftment after transplantation, and also reduced the demand for red blood cell and platelet transfusions compared to G-CSF alone. A multi-center, prospective random clinical study is essential to compare the efficacy and safety of novel mobilization regimen with IL-11 plus G-CSF to G-CSF alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) with newly diagnosed multiple myeloma or lymphoma
- •Suitable candidates for autologous hematopoietic stem cell transplantation (auto-HSCT)
- •Zubrod (ECOG) performance status < 4
- •Left ventricular ejection fraction (LVEF) > 40%
- •No uncontrolled arrhythmia or unstable cardiac disease
- •Corrected QT interval (QTc) < 470 ms
- •No symptomatic pulmonary disease, with acceptable pulmonary function tests
- •Serum alanine aminotransferase (ALT) < 4 × upper limit of normal (ULN)
- •Total bilirubin < 2 × upper limit of normal (ULN)
排除标准
- •Intolerance to auto-HSCT
- •Prior exposure to other stem cell mobilizing agents
- •Pregnancy or lactation
- •Psychiatric disorders precluding participation
- •Positive serology for HIV (HIV-1/2), hepatitis B, or hepatitis C
研究组 & 干预措施
G-CSF+IL-11
rhG-CSF 5 μg/kg/day for 6 days plus rhIL-11 50 μg/kg/day for 5 days
干预措施: G-CSF+IL-11 (Drug)
G-CSF
rhG-CSF 5 μg/kg/day subcutaneously for 6 days.
干预措施: G-CSF Granulocyte-Colony Stimulating Factor (Drug)
结局指标
主要结局
hematopoietic engraftment time (including granulocyte engraftment and platelet engraftment)
时间窗: Data on engraftment will be collected daily from stem cell infusion (Day 0) until the occurrence of both engraftment events or up to a maximum of 100 days, whichever comes first.
Granulocyte Engraftment Time: Defined as the number of days from stem cell infusion (Day 0) to the first of three consecutive days with an Absolute Neutrophil Count (ANC) \> 0.5 × 10\^9/L. Platelet Recovery Time: Defined as the number of days from stem cell infusion (Day 0) to the first day of seven consecutive days with a platelet count (PLT) ≥ 20 × 10\^9/L without transfusion support.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: Adverse events are monitored from the time of enrollment (first study intervention) through the end of the study, with an expected average follow-up of 12 months.
AEs were evaluated according to the National Cancer Institute Common Terminology Criteria of Adverse Events, version 4.0.
次要结局
- progression-free survival (PFS) and overall survival (OS)(PFS: From randomization to disease progression or death from any cause, whichever occurs first, through study completion, an average of 1 year. OS: From randomization to death from any cause, through study completion, an average of 1 year.)