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

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: Hematopoetic Stem Cell Transplantation; Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB); Hemato-oncologic Patients
• Intervention / Treatment: Drug: G-CSF+IL-11; Drug: G-CSF Granulocyte-Colony Stimulating Factor

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jiexian Ma; Phone Number: +86 13764520566; Email: jiexianma@hotmail.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Zhilei Bian; Phone Number: +86 13918803148; Email: bianzhilei@sina.com
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200065
      • Recruiting
      • Tongji Hospital of Tongji University
      • Contact: Wenjun Zhang; Phone Number: +86 13918803148; Email: zhangwenjun@tongji.edu.cn
    • Shanghai, Shanghai Municipality, China, 200040
      • Recruiting
      • Huadong Hospital, Fudan University
      • Contact: Jiexian Ma; Phone Number: +8613764520566; Email: jiexianma@hotmail.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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	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)	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

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

Study record dates

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: mobilization; hematopoetic stem cell transplantation; IL-11
• 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