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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.
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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | PEG-rhG-CSF |
|
| control group | Active Comparator | rhG-CSF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-rhG-CSF | Drug | 48-72 hours after chemotherapy,9 mg of PEG-rhG-CSF was injected subcutaneously for mobilization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mobilization success rate | Accumulate CD34+cells ≥ 2×106/kg for 3 times or less | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Speed of recovery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ou Bai, doctor | Contact | 13039046656 | oubai16@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ou Bai, doctor | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Bethune Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41510127 | Derived | Wang B, Cao L, Li J, Zhao Y, Li J, Wen Y, Yan P, Guo W, Bai O. Polyethylene glycol-conjugated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) primary prophylaxis significantly reduces the duration of neutropenia in non-Hodgkin's lymphoma patients treated with chemotherapy: a randomised trial (NCT05834751). Transl Cancer Res. 2025 Dec 31;14(12):8990-9001. doi: 10.21037/tcr-2025-1-2613. Epub 2025 Dec 29. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 21, 2026 | |
| Reset | May 11, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 21, 2026 | May 11, 2026 | |||
| Jul 8, 2026 |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C423652 | pegylated granulocyte colony-stimulating factor |
| C455861 | pegfilgrastim |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| RhG-CSF | Drug | After clinical evaluation, rhG-CSF was given 10μ g/kg/d for mobilization until the stem cell collection was completed. |
|
|
The number of days when the leucocyte trough rose to the peak |
| 30 days |
| Time of highest point of CD34+ cells | Time of highest point of CD34+ cells | 30 days |
| Single acquisition volume | Single acquisition volume | 30 days |
| Acquisition times | Acquisition times | 30 days |
| Administration times of rhG-CSF | Administration times of rhG-CSF | 30 days |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |