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

NCT07362810 | Recruiting Phase 2 DMC

• 1 other identifier: 2025K388-F251
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hematopoetic Stem Cell Transplantation; Hemato-oncologic Patients; Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)

Keywords

IL-11; mobilization; hematopoetic stem cell transplantation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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.

Study Arms (2)

G-CSF+IL-11

EXPERIMENTAL

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

Drug: G-CSF+IL-11

G-CSF

ACTIVE COMPARATOR

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

Drug: G-CSF Granulocyte-Colony Stimulating Factor

Interventions

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+IL-11

G-CSF Granulocyte-Colony Stimulating Factor DRUG

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

G-CSF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (3)

The first affiliated hospital of Zhengzhou university

Zhengzhou, Henan, 450052, China

RECRUITING

Huadong Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, 200065, China

RECRUITING

Study Officials

• Jiexian Ma

  Huadong Hospitai, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiexian Ma

CONTACT

+86 13764520566; jiexianma@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: random assigned, two groups, one group was the novel regimen of G-CSF plus IL-11, another one is the traditional regimen G-CSF alone.

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 23, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year after completion of this study
• Access Criteria: all researchers can require the IPD and supporting information from principal investigator of the study (Email: jiexianma@hotmail.com)

Locations

CN (3)