G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: G-CSF+IL-11, G-CSF Granulocyte-Colony Stimulating Factor.
- Who it may be relevant to
- Registry conditions: Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB), Hematopoetic Stem Cell Transplantation, Hemato-oncologic Patients. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation
Overview
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.
Interventions
- Drug 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 Granulocyte-Colony Stimulating Factor
rhG-CSF 5 μg/kg/day subcutaneously for 6 days
Primary outcome measures
- 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.]
- 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.]
Secondary outcome measures (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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 3 centers
- The first affiliated hospital of Zhengzhou university — Zhengzhou
- Huadong Hospital, Fudan University — Shanghai
- Tongji Hospital of Tongji University — Shanghai
Identifiers
NCT: NCT07362810 · 2025K388-F251