Fuling Zhou, Head, Division of Hematology; Professor of Hematology; Doctoral Advisor, Zhongnan Hospital
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total CD34+ cell yield (106/kg)
研究概览
简要总结
The aim of this study was to evaluate the difference in the accuracy of CD34+ cell detection by immunomagnetic bead method and flow cytometry in patients with hematologic malignancies pre-treated with stem cell transplantation after mobilization, and the results were compared simultaneously in the groups applying different mobilization protocols.
详细描述
Treatment programs The mobilization protocol is.
- etoposide 0.1 grams per square meter qd d1-3
- algocytidine 0.5 grams per square meter q12h d1-3
- whitening injection (subcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group on the second day after chemotherapy, and G-CSF 5ug/kg/d in the control group from the fifth day after chemotherapy until the end of collection).
In both groups, routine blood tests were performed daily, and the percentage of CD34+ cells in peripheral blood was monitored from the time leukocytes started to rise after the nadir by immunomagnetic bead assay and flow cytometry, and collection was initiated if the percentage of CD34+ was >0.1% and peripheral blood leukocytes were >3.5×109/L.
Collection was stopped when the CD34+ cell count was >5×106/kg, and no more than three attempts were made. Collection was considered a failure when CD34+ cells collected in any of the three attempts did not reach 2×106/kg.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malignant lymphoma diagnosed by histology and/or cytology; expected survival > 3 months.
- •Patients evaluated for disease in complete or partial remission.
- •Normal bone marrow hematopoietic function; no significant cardiac or pulmonary dysfunction.
- •Liver function and biochemical tests need to meet the following criteria. ALT and AST ≤ 1.5×ULN. TBIL≤1.5×ULN. Blood creatinine ≤ 1.5 × ULN.
- •PS score of 0-
- •Women of childbearing potential must have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result and be willing to use an appropriate method of contraception for the duration of the trial.
- •Subjects voluntarily enrolled in the study, signed an informed consent form, were compliant and cooperated with the follow-up.
排除标准
- •Pregnant or lactating women.
- •having other hematological disorders affecting the hematopoietic function of the bone marrow
- •those with acute or active infections who have received systemic anti-infective therapy within 72h
- •who are allergic to the study drug or other G-CSF products, or to biological agents expressed by E. coli
- •Those who, in the judgment of the investigator, have a serious concomitant disease that jeopardizes patient safety or interferes with the patient's ability to complete the study
- •Other conditions that, in the judgment of the investigator, are not suitable for inclusion in this study.
研究组 & 干预措施
PEG-rhG-CSF
Subcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group the day after the end of chemotherapy
干预措施: PEG-rhG-CSF (Drug)
G-CSF
G-CSF 5ug/kg/d from day 5 after the end of chemotherapy until the end of collection
干预措施: G-CSF (Drug)
结局指标
主要结局
Total CD34+ cell yield (106/kg)
时间窗: through study completion, an average of 1 year
Total CD34+ cell yield (106/kg)
次要结局
- Accuracy differences between immunomagnetic bead assays and flow cytometry assays(through study completion, an average of 1 year)
- Height(One day before chemotherapy)
- Weight(One day before chemotherapy)
- ECOG score (d1 pre-chemotherapy)(One day before chemotherapy)
- Vital signs and physical examination(One day before chemotherapy)
- Blood routine(Blood routine was tested daily, an average of 1 year)
- Adverse event record(through study completion, an average of 1 year)
研究者
Fuling Zhou
Head, Division of Hematology; Professor of Hematology; Doctoral advisor, Zhongnan Hospital
Zhongnan Hospital