G‑CSF plus IL‑11 for faster blood recovery after autologous stem cell transplant
The Impact of G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation
This phase 2 trial will test whether adding IL‑11 to G‑CSF improves mobilization and speeds platelet and red blood cell recovery in adults having autologous stem cell transplant for multiple myeloma or lymphoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 3 sites (Zhengzhou, Henan and 2 other locations) |
| Trial ID | NCT07362810 on ClinicalTrials.gov |
What this trial studies
This randomized phase 2 intervention compares standard G‑CSF mobilization with G‑CSF combined with IL‑11 in adults preparing for autologous hematopoietic stem cell transplantation. Participants receive mobilization treatment before stem cell collection and subsequent transplant, with monitoring of blood progenitor yields and post‑transplant hematopoietic recovery. The study emphasizes megakaryocytic and erythroid progenitor counts in peripheral blood as key outcomes and tracks time to platelet and red cell engraftment. Safety and tolerability of the combination regimen are also monitored.
Who should consider this trial
Good fit: Adults (≥18) with newly diagnosed multiple myeloma or lymphoma who are candidates for autologous HSCT and have adequate cardiac, pulmonary, hepatic function and performance status are ideal candidates.
Not a fit: Patients who are pregnant or breastfeeding, have prior exposure to other mobilizing agents, active HIV/hepatitis infection, or significant uncontrolled cardiac/pulmonary disease are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combination could increase mobilized platelet and red cell progenitors and shorten the time to platelet and erythrocyte recovery after transplant.
How similar studies have performed: Preclinical work showed synergy between IL‑11 and G‑CSF toward megakaryocytic/erythroid progenitors, and a small single‑center prospective study in China (ChiCTR2500100054) reported increased functional megakaryocytic/erythroid progenitors after five days, but evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zhengzhou, Henan and 2 other locations
- The first affiliated hospital of Zhengzhou university — Zhengzhou, Henan, China (Recruiting)
- Huadong Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
- Tongji Hospital of Tongji University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jiexian Ma — Huadong Hospitai, Fudan University
- Study coordinator: Jiexian Ma
- Email: jiexianma@hotmail.com
- Phone: +86 13764520566
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.