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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-CSF+IL-11 | Experimental | rhG-CSF 5 μg/kg/day for 6 days plus rhIL-11 50 μg/kg/day for 5 days |
|
| G-CSF | Active Comparator | rhG-CSF 5 μg/kg/day subcutaneously for 6 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-CSF+IL-11 | Drug | rhG-CSF 5 μg/kg/day for 6 days plus rhIL-11 50 μg/kg/day for 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| hematopoietic engraftment time (including granulocyte engraftment and platelet engraftment) | 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. | 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. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | AEs were evaluated according to the National Cancer Institute Common Terminology Criteria of Adverse Events, version 4.0. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiexian Ma | Contact | +86 13764520566 | jiexianma@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiexian Ma | Huadong Hospitai, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Zhengzhou university | Recruiting | Zhengzhou | Henan | 450052 | China |
All collected IPD
1 year after completion of this study
all researchers can require the IPD and supporting information from principal investigator of the study (Email: jiexianma@hotmail.com)
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random assigned, two groups, one group was the novel regimen of G-CSF plus IL-11, another one is the traditional regimen G-CSF alone.
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| G-CSF Granulocyte-Colony Stimulating Factor |
| Drug |
rhG-CSF 5 μg/kg/day subcutaneously for 6 days |
|
| Huadong Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
|
| Tongji Hospital of Tongji University | Recruiting | Shanghai | Shanghai Municipality | 200065 | China |
|