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

Condition(s) studied

Investigational drug(s) / intervention(s)

G-CSF+IL-11: rhG-CSF 5 μg/kg/day for 6 days plus rhIL-11 50 μg/kg/day for 5 days

G-CSF Granulocyte-Colony Stimulating Factor: rhG-CSF 5 μg/kg/day subcutaneously for 6 days

Study 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.

Eligibility

Primary outcome measure(s)

• hematopoietic engraftment time (including granulocyte engraftment and platelet engraftment) — 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 — 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.

Trial sites (3)

More Fudan University trials in China

Other trials for the same condition