G‑CSF plus IL‑11 for faster blood recovery after autologous stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The First Affiliated Hospital of Fujian Medical University
  Fuzhou, Fujian, China Recruiting
• The first affiliated hospital of Zhengzhou university
  Zhengzhou, Henan, China Recruiting
• Jiangxi Cancer Hospital
  Nanchang, Jiangxi, China Recruiting
• Huadong Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• Tongji Hospital of Tongji University
  Shanghai, Shanghai Municipality, China Recruiting
• Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.