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A study for efficacy and safety of long acting G-CSF and short acting G-CSF in the mobilization in allogeneic hematopoietic stem cell transplantation

Efficacy and safety of long acting G-CSF and short acting G-CSF in the mobilization in allogeneic hematopoietic stem cell transplantation:a single center, random, control clinical trail

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032370
Enrollment
Unknown
Registered
2020-04-26
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy donors for allogeneic hematopoietic stem cell transplantation

Interventions

PEG-rhG-CSF group:PEG-rhG-CSF 12mg d1
rhG-CSF group:rhG-CSF 10ug/kg d1-d4

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Aged 14-60 years old; 2) Gender: male or female; 3) relationship between allogeneic hematopoietic stem cell transplantation of healthy donors; 4) Weight >=40kg; 5) General condition is acceptable, ECOG score=50%; 7) Normal liver and kidney function: serum bilirubin <=35umol/L, AST / ALT is below twice the upper limit of normal value, serum creatinine <=130 umol/L; 8) The subject signs the informed consent.

Exclusion criteria

Exclusion criteria: 1. unrelated allogeneic hematopoietic stem cell transplantation 2. ECOG score> 2; 3. Uncontrolled active infection; 4. Patients with renal insufficiency (creatinine >=176.8lmol/l); 5. Liver insufficiency (total bilirubin> 34.2 umol/L, ALT, AST>=3 times the upper limit of normal); 6. Patients with cardiac insufficiency (LVEF 12.95 mmol/l or triglyceride>5.65 mmol/l and the HIV antibody positive; 8. Pregnant or breastfeeding women; 9. Infected with human immunodeficiency virus (HIV); 10. Other situations that do not meet the enrolled criteria.

Design outcomes

Primary

MeasureTime frame
CD34+ cell counts;mononuclear cell counts;collection times;adverse effect;

Secondary

MeasureTime frame
T cell subgroup;B cell subgroup;ratio of MDSC;expense of collection;non-relapsed mortality;transplantation related mortal;the ratio of GVHD;overall survival;disease free survival;the ratio of infection;leukocyte engraftment time;platele engraftment time;

Countries

China

Contacts

Public ContactYicheng Zhang

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

yczhang@tjh.tjmu.edu.cn+86 027-83663478

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026