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

January 22, 2026 updated by: Zhijun Bao, Fudan University

The Impact of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

224

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • the First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200065
        • Recruiting
        • Tongji Hospital of Tongji University
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200040
        • Recruiting
        • Huadong Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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+IL-11
rhG-CSF 5 μg/kg/day for 6 days plus rhIL-11 50 μg/kg/day for 5 days
Active Comparator: G-CSF
rhG-CSF 5 μg/kg/day subcutaneously for 6 days.
Drug: G-CSF Granulocyte-Colony Stimulating Factor
rhG-CSF 5 μg/kg/day subcutaneously for 6 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Jiexian Ma, Huadong Hospitai, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025K388-F251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD

IPD Sharing Time Frame

1 year after completion of this study

IPD Sharing Access Criteria

all researchers can require the IPD and supporting information from principal investigator of the study (Email: jiexianma@hotmail.com)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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