A Phase 2 interventional study of G-CSF+IL-11 and G-CSF Granulocyte-Colony Stimulating Factor in Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB), Hematopoetic Stem Cell Transplantation and Hemato-oncologic Patients, sponsored by Fudan University. Recruiting at 3 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
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.
Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
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Exclusion Criteria:
rhG-CSF 5 μg/kg/day for 6 days plus rhIL-11 50 μg/kg/day for 5 days
Drug: G-CSF+IL-11
rhG-CSF 5 μg/kg/day subcutaneously for 6 days.
Drug: G-CSF Granulocyte-Colony Stimulating Factor
rhG-CSF 5 μg/kg/day for 6 days plus rhIL-11 50 μg/kg/day for 5 days
rhG-CSF 5 μg/kg/day subcutaneously for 6 days
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.
Time frame: 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.
Time frame: 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.
progression-free survival (PFS) and overall survival (OS)
Time frame: 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.
Plan to share: Yes — All collected IPD
Supporting information: Study protocol, Sap, Icf
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