Status:
UNKNOWN
A Clinical Study of Autologous Peripheral Blood Stem Cell Mobilization for PEG-G-CSF
Lead Sponsor:
Ning Huang
Conditions:
Granulocyte Colony-stimulating Factor
Stem Cell Mobilization
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Have a comparison between pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) and recombinant human granulocyte-colony stimulating factor (rhG-CSF) for difference in effica...
Detailed Description
Key issues to be addressed: To compare the efficiency of stem cell mobilization and hematopoietic system reconstruction between PEG-rhG-CSF and rrhG-CSF. Research design: A multicenter, open, prosp...
Eligibility Criteria
Inclusion
- Patients diagnosed as hematological diseases definitely, body weight ≥30kg, age: 18-60 years, without limitation in gender or race;
- Patients who receive APBSCT voluntarily;
- Patients who participate in the open randomized controlled study of autologous hematopoietic stem cell mobilization for PEG-rhG-CSF and G-CSF voluntarily;
- Each subject must sign the informed consent from (ICF) to indicate that he/she understands the purposes and procedures of the study, and participates in the study voluntarily. Considering the patient's conditions, if the patient's signature is not conducive to treatment, his/her legal representative will sign the ICF.
Exclusion
- Patients who have serious organ dysfunctions or diseases, such as serious diseases or dysfunctions heart, liver, kidney, pancreas and etc.;
- Patients who cannot tolerate autologous hematopoietic stem cell transplantation and autologous stem cell mobilization;
- Subjects who and/or whose authorized family members refuse HSCT or PEG-rhG-CSF treatment;
- Subjects with any life-threatening disease, medical condition or organ system dysfunction compromising their safety or causing unnecessary risks for the study results in the investigator' opinion, with drug dependence, with uncontrolled mental illness, or with cognitive dysfunction;
- Subjects who participate in other similar clinical studies within 3 months;
- Subjects who are considered as unsuitable for the study by the investigator (e.g., those expected to be unable to adhere to relevant treatment regimen due to financial problems).
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05409547
Start Date
June 30 2022
End Date
April 30 2025
Last Update
June 16 2022
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