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An open randomized controlled non-inferiority study of pegylated recombinant human granulocyte stimulating factor injection and recombinant human granulocyte colony-stimulating factor in promoting granulocyte implantation after umbilical cord blood transplantation in children

An open randomized controlled non-inferiority study of pegylated recombinant human granulocyte stimulating factor injection and recombinant human granulocyte colony-stimulating factor in promoting granulocyte implantation after umbilical cord blood transplantation in children

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051086
Enrollment
Unknown
Registered
2021-09-12
Start date
2021-09-13
Completion date
Unknown
Last updated
2022-05-16

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

Conditions

Childhood HSCT

Interventions

group A:PEG-RHG-CSF group was given on day 6 after transplantation, 100ug/kg (Max. 6mg)
group B:rhG-csf group was subcutaneously injected 5ug/kg/d (maximum 300ug/d) on day 6 after umbilical cord blood transplantation

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged 1-18 years, no gender limitation; 2. Patients with leukemia, lymphoma or solid tumors who received their first umbilical cord blood hematopoietic stem cell transplantation; 2. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe cardiac insufficiency and cardiac ejection fraction EF less than 60%; Or severe arrhythmias; 2. With severe pulmonary insufficiency (obstructive or restrictive ventilatory disorder); 3. With severe liver function impairment, liver function indexes (ALT, TBIL) were more than 3 times higher than the upper limit of normal value (ULN). 4. With severe renal insufficiency, the renal function index (Cr) was more than 2 times higher than the upper normal value (ULN). 5. Or Cr of 24 hours urinary creatinine clearance was lower than 50ml/min; 6. Severe active infection before transplantation; Infections that are difficult to control after transplantation; 7. Have a history of allergy or intolerance to domestic pegylated recombinant human granulocyte stimulating factor; The investigator evaluated other reasons for ineligibility.

Design outcomes

Primary

MeasureTime frame
Neutrophil recovery time;

Secondary

MeasureTime frame
side effects;

Countries

China

Contacts

Public ContactXu Honggui

Sun Yat-Sen Memorial Hosipital

xuhgui@mail.sysu.edu.cn+86 13650841291

Outcome results

None listed

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