Actively Recruiting
G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation
Led by Fudan University · Updated on 2026-01-23
224
Participants Needed
3
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (≥18 years) with newly diagnosed multiple myeloma or lymphoma
- Suitable candidates for autologous hematopoietic stem cell transplantation (auto-HSCT)
- Zubrod (ECOG) performance status less than 4
- Left ventricular ejection fraction (LVEF) greater than 40%
- No uncontrolled arrhythmia or unstable cardiac disease
- Corrected QT interval (QTc) less than 470 ms
- No symptomatic pulmonary disease, with acceptable pulmonary function tests
- Serum alanine aminotransferase (ALT) less than 4 times upper limit of normal (ULN)
- Total bilirubin less than 2 times upper limit of normal (ULN)
You will not qualify if you...
- Intolerance to autologous hematopoietic stem cell transplantation
- 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
AI-Screening
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Trial Site Locations
Total: 3 locations
1
The first affiliated hospital of Zhengzhou university
Zhengzhou, Henan, China, 450052
Actively Recruiting
2
Huadong Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
3
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China, 200065
Actively Recruiting
Research Team
J
Jiexian Ma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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