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

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ou Bai, MD/PHD

Criteria

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.