the Efficacy and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma

Lymphoma Clinical Trial

Official title:

Clinical Study on the Effectiveness and Safety of Pegylated Recombinant Human Granulocyte Stimulating Factor Injection and PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05834751
• Other study ID #: CSPC-JYL-PBSCT-03A
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: April 2023
• Source: The First Hospital of Jilin University
• Contact: Ou Bai, doctor
• Phone: 13039046656
• Email: oubai16[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A single center, non-inferiority, two-way cohort clinical study to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.

Description:

The objective was to to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.

lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation; KPS score ≥70; Ccr≥ 50 mL/min, TBIL< 25.65 umol/L, ALT and AST < 2 times the upper limit of normal value;

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: July 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 18-65 years old, regardless of gender;

2. lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation;

3. KPS score =70;

4. Ccr= 50 mL/min, TBIL< 25.65 umol/L, ALT and AST < 2 times the upper limit of normal value;

5. ANC = 1.5×109/L,PLT = 80×109/L,Hb = 75g/L,WBC = 3.0×109/L;

6. Patients can tolerate chemotherapy;

7. No active infection before chemotherapy;

8. The retrospective enrolled subjects are exempted from informed consent for data collection, and the prospective enrolled subjects voluntarily participate in this experiment and sign the informed consent form;

9. The researcher thinks that the subjects can benefit.

Exclusion Criteria:

1. Patients with megaspleen (when inhaling deeply, the spleen exceeds the right umbilicus and/or below the umbilical level);

2. Those who have received mobilization and transplantation of allogeneic or autologous hematopoietic stem cells before;

3. Subjects who have evidence of serious or uncontrollable systemic diseases (such as unstable or irreparable respiratory, heart, liver or kidney diseases) according to the researcher's judgment;

4. severe mental or nervous system diseases;

5. Those who are allergic to PEG-rhG-CSF, rhG-CSF and any active ingredients or auxiliary materials of other preparations expressed by Escherichia coli, or have a clear history of protein drug allergy, specific allergic reaction (asthma, rheumatism, eczema dermatitis) or have had other serious allergic reactions;

6. pregnant or lactating female patients; Women of childbearing age refuse to accept contraceptive measures; Those who plan to become pregnant during the study period;

7. The researcher judges other subjects who are not suitable to participate.

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• PEG-rhG-CSF
48-72 hours after chemotherapy,9 mg of PEG-rhG-CSF was injected subcutaneously for mobilization
• RhG-CSF
After clinical evaluation, rhG-CSF was given 10µ g/kg/d for mobilization until the stem cell collection was completed.

Locations

Country	Name	City	State
China	The First Bethune Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Ou Bai, MD/PHD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobilization success rate	Accumulate CD34+cells = 2×106/kg for 3 times or less	48 months
Secondary	White blood cell trough and peak	The treatment period is from the beginning of chemotherapy to the end of collection, the trough value is recorded at the beginning of chemotherapy, and the peak value is recorded after PEG-rhG-CSF is applied	30 days
Secondary	Speed of recovery	The number of days when the leucocyte trough rose to the peak	30 days
Secondary	Time of highest point of CD34+ cells	Time of highest point of CD34+ cells	30 days
Secondary	Single acquisition volume	Single acquisition volume	30 days
Secondary	Acquisition times	Acquisition times	30 days
Secondary	Administration times of rhG-CSF	Administration times of rhG-CSF	30 days