RecruitingPhase 2NCT07362810

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


Sponsor

Fudan University

Enrollment

224 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria9

  • 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%
  • No uncontrolled arrhythmia or unstable cardiac disease
  • Corrected QT interval (QTc) \< 470 ms
  • No symptomatic pulmonary disease, with acceptable pulmonary function tests
  • Serum alanine aminotransferase (ALT) \< 4 × upper limit of normal (ULN)
  • Total bilirubin \< 2 × upper limit of normal (ULN)

Exclusion Criteria5

  • Intolerance to auto-HSCT
  • Prior exposure to other stem cell mobilizing agents
  • Pregnancy or lactation
  • Psychiatric disorders precluding participation
  • Positive serology for HIV (HIV-1/2), hepatitis B, or hepatitis C

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Interventions

DRUGG-CSF+IL-11

rhG-CSF 5 μg/kg/day for 6 days plus rhIL-11 50 μg/kg/day for 5 days

DRUGG-CSF Granulocyte-Colony Stimulating Factor

rhG-CSF 5 μg/kg/day subcutaneously for 6 days


Locations(3)

The first affiliated hospital of Zhengzhou university

Zhengzhou, Henan, China

Huadong Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, China

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NCT07362810


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