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NCT Number: NCT07362810

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The first affiliated hospital of Zhengzhou university, Zhengzhou, Henan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

G-CSF+IL-11

Drug

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

Drug

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

Primary outcomes

  1. hematopoietic engraftment time (including granulocyte engraftment and platelet engraftment)

    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.

    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.

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    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.

    AEs were evaluated according to the National Cancer Institute Common Terminology Criteria of Adverse Events, version 4.0.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiexian Ma

CONTACT

[email protected]

+86 13764520566

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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