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The Impact of 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of combining two drugs, G-CSF and IL-11, to improve the mobilization of blood stem cells in patients with blood cancers like multiple myeloma or lymphoma. This Phase 2 trial aims to find out if adding IL-11 to the usual G-CSF treatment can increase the number of certain blood-forming stem cells, potentially speeding up recovery after autologous hematopoietic stem cell transplantation (auto-HSCT). Previous smaller studies suggested this combination might help patients recover blood cells faster and reduce the need for transfusions. Participants will be randomly assigned to receive either a combination of recombinant human G-CSF (5 micrograms per kilogram per day for 6 days) plus recombinant human IL-11 (50 micrograms per kilogram per day for 5 days), or G-CSF alone at the same dose and duration. This trial is triple-blinded, meaning that participants, caregivers, and researchers do not know which treatment is given to avoid bias. The study will monitor the time it takes for blood cell recovery and any treatment-related side effects. During the study, participants will be followed daily from the day of stem cell infusion until their blood cells have engrafted or for up to 100 days. Researchers will track the time for granulocyte and platelet recovery, record any adverse events for about 12 months, and assess longer-term outcomes like progression-free survival and overall survival over approximately one year. The total participation period and detailed monitoring will help assess both the safety and effectiveness of the new drug combination.
CONDITIONS
Brief 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 < 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 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 days for G-CSF and 5 days for IL-11
Participants receive either G-CSF plus IL-11 or G-CSF alone to support hematopoietic reconstitution after autologous stem cell transplantation.
Daily visits for up to 6 days during treatment
Duration - Approximately 12 months
Participants are monitored for safety, progression-free survival, and overall survival after treatment.
Regular follow-up visits during the 12-month period
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
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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