NCT07362810

G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation

The Impact of G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)
• Hematopoetic Stem Cell Transplantation
• Hemato-oncologic Patients

Interventions

Type	Name	Description
DRUG	G-CSF+IL-11	rhG-CSF 5 μg/kg/day for 6 days plus rhIL-11 50 μg/kg/day for 5 days
DRUG	G-CSF Granulocyte-Colony Stimulating Factor	rhG-CSF 5 μg/kg/day subcutaneously for 6 days

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

3 sites across 1 country: China