A Clinical Study of Autologous Peripheral Blood Stem Cell Mobilization for PEG-G-CSF

• Status: Not yet recruiting
• Trial end date: 2025-04-30
• Target enrollment: 0
• Participant gender: All

Summary

Have a comparison between pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) and granulocyte-colony stimulating factor (G-CSF) for difference in efficacy of hematopoietic reconstruction after autologous peripheral blood stem cell mobilization ( PBSCM) and autologous peripheral blood stem cell transplantation (APBSCT).

Primary purpose:

1. Count of collected CD34+ cells and mononuclear cells.

2. Proportion of patients with successful mobilization (CD34+ > 2×106 /kg)

Secondary purpose:

1. Proportion of qualified patients in a single collection.

2. Neutrophil and platelet reconstruction time

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ning Huang
• Treatments: Lenograstim

Criteria

Inclusion Criteria:

1. Patients diagnosed as hematological diseases definitely, body weight ≥30kg, age: 18-60 years, without limitation in gender or race;

2. Patients who receive APBSCT voluntarily;

3. Patients who participate in the open randomized controlled study of autologous hematopoietic stem cell mobilization for PEG-rhG-CSF and G-CSF voluntarily;

4. 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 Criteria:

1. Patients who have serious organ dysfunctions or diseases, such as serious diseases or dysfunctions heart, liver, kidney, pancreas and etc.;

2. Patients who cannot tolerate autologous hematopoietic stem cell transplantation and autologous stem cell mobilization;

3. Subjects who and/or whose authorized family members refuse HSCT or PEG-rhG-CSF treatment;

4. 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;

5. Subjects who participate in other similar clinical studies within 3 months;

6. 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).