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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFudan University

About this trial

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 criteria

Qualifiers

Adults (≥18 years) with newly diagnosed multiple myeloma or lymphoma

Suitable candidates for autologous hematopoietic stem cell transplantation (auto-HSCT)

Zubrod (ECOG) performance status < 4

Left ventricular ejection fraction (LVEF) > 40%

Disqualifiers

Intolerance to auto-HSCT

Prior exposure to other stem cell mobilizing agents

Pregnancy or lactation

Psychiatric disorders precluding participation

Trial design

Treatments tested in this trial

  • G-CSF+IL-11
  • G-CSF Granulocyte-Colony Stimulating Factor

Treatment groups

224 Participants
are divided into 2 treatment groups

Sponsors and collaborators