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

Ou Bai, MD/PHD

Status: Not yet enrolling

Conditions: Lymphoma

Treatments: Drug: RhG-CSF; Drug: PEG-rhG-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT05834751

CSPC-JYL-PBSCT-03A

Details and patient eligibility

About

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.

Full 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;

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

experimental group

Experimental group

Description:

PEG-rhG-CSF

Treatment:

Drug: PEG-rhG-CSF

control group

Active Comparator group

Description:

rhG-CSF

Treatment:

Drug: RhG-CSF