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

Fudan University

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: G-CSF Granulocyte-Colony Stimulating Factor; Drug: G-CSF+IL-11

Study type: Interventional

Funder types: Other

Identifiers

NCT07362810

2025K388-F251

Details and patient eligibility

About

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.

Enrollment: 224 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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224 participants in 2 patient groups

G-CSF+IL-11

Experimental group

Description:

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

Treatment:

Drug: G-CSF+IL-11

G-CSF

Active Comparator group

Description:

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

Treatment:

Drug: G-CSF Granulocyte-Colony Stimulating Factor