the Efficacy and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma
NCT ID: NCT05834751
Last Updated: 2023-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
144 participants
INTERVENTIONAL
2023-05-01
2025-07-01
Brief Summary
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Detailed Description
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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;
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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experimental group
PEG-rhG-CSF
PEG-rhG-CSF
48-72 hours after chemotherapy,9 mg of PEG-rhG-CSF was injected subcutaneously for mobilization
control group
rhG-CSF
RhG-CSF
After clinical evaluation, rhG-CSF was given 10μ g/kg/d for mobilization until the stem cell collection was completed.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Ou Bai, MD/PHD
OTHER
Responsible Party
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Ou Bai, MD/PHD
Director
Principal Investigators
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Ou Bai, doctor
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
Locations
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The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Countries
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Central Contacts
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Facility Contacts
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Ou Bai, doctor
Role: primary
Other Identifiers
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CSPC-JYL-PBSCT-03A
Identifier Type: -
Identifier Source: org_study_id