NCT07362810 G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation
| NCT ID | NCT07362810 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB) |
| Study Type | INTERVENTIONAL |
| Enrollment | 224 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 224 participants in total. It began in 2026-01-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Jiexian Ma
PRINCIPAL INVESTIGATOR
Huadong Hospitai, Fudan University
Frequently Asked Questions
Who can join the NCT07362810 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07362810 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07362810 currently recruiting?
Yes, NCT07362810 is actively recruiting participants. Contact the research team at jiexianma@hotmail.com for enrollment information.
Where is the NCT07362810 trial being conducted?
This trial is being conducted at Zhengzhou, China, Shanghai, China, Shanghai, China.
Who is sponsoring the NCT07362810 clinical trial?
NCT07362810 is sponsored by Fudan University. The principal investigator is Jiexian Ma at Huadong Hospitai, Fudan University. The trial plans to enroll 224 participants.