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| Name | Class |
|---|---|
| First Affiliated Hospital of Zhejiang University | OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University | OTHER |
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This study utilizes a prospective, multicenter, randomized two-arm design to evaluate the efficacy and safety of the etoposide, cytarabine, and pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) combination therapy (EAP regimen) in mobilizing hematopoietic stem cells in patients with non-Hodgkin's lymphoma (NHL). A total of 99 NHL patients will be enrolled as research subjects and will be randomly allocated in a 2:1 ratio to compare the EAP regimen versus disease-specific chemotherapy mobilization regimen. The primary endpoint is the proportion of patients achieving the ideal collection value after a single collection (CD34+ cells ≥5×10^6/kg).
Based on strict inclusion and exclusion criteria, a total of 99 non-Hodgkin's lymphoma patients from 16 hospitals will be selected. Eligible subjects will be randomly assigned in a 2:1 ratio to either the experimental group or the control group. The experimental group will receive the EAP regimen, which combines etoposide, cytarabine, and pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF), while the control group will receive disease-specific chemotherapy mobilization regimens, such as the CHOP and Hyper-CVAD. Subsequently, the number of CD34+ cells will be monitored. The study will evaluate the proportion of patients achieving the ideal collection value after a single collection (CD34+ cells ≥5×106/kg); the proportion of patients achieving the target collection value cumulatively; the total amount of CD34+ cells collected and the average number of collections; hematological and non-hematological adverse reactions; and the proportion of patients receiving plerixafor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EAP regimen group | Experimental | 66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy. |
|
| Disease-specific chemotherapy mobilization regimens group | Active Comparator | 33 subjects will be enrolled into the disease-specific chemotherapy mobilization regimens group. The disease-specific chemotherapy mobilization regimens include but not limited to: CHOP, Hyper-CVAD, ID-MTX+Ara-C. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoposide | Drug | Day 1~Day 2: 75mg/m^2 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| % of patients achieving the collection of ≥5×10^6 CD34+ cells/kg | Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10^6/kg) after a single collection. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg | To observe and compare the proportion of patients who cumulatively achieve the target collection value (CD34+ cells ≥ 2×10^6/kg) between the EAP regimen and the disease-specific chemotherapy regimen; the proportion of patients who achieve the ideal collection value. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peipei Ye | Contact | 86-13685832706 | 39612903@qq.com | |
| Ying Lu | Contact | 86-13486090834 | 814871416@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Peipei Ye | The Affiliated People's Hospital of Ningbo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongyang People's Hospital | Recruiting | Dongyang | Zhejiang | China |
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| Jinhua People's Hospital | OTHER |
| The Central Hospital of Lishui City | OTHER |
| Shaoxing People's Hospital | OTHER |
| Shaoxing Second Hospital | OTHER |
| Zhejiang Provincial Tongde Hospital | OTHER |
| Taizhou Hospital | OTHER |
| Dongyang People's Hospital | OTHER |
| Affiliated Hospital of Jiaxing University | OTHER |
| Huzhou Central Hospital | OTHER |
| Second Affiliated Hospital of Wenzhou Medical University | OTHER |
| Ningbo Medical Center Lihuili Hospital | OTHER_GOV |
| Jinhua Municipal Central Hospital | OTHER |
Prospective, randomized, two-arm, multicenter, exploratory study
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| Cytarabine | Drug | Day 1~Day 2: 200g/m^2, q12h |
|
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| PEG-rhG-CSF | Drug | Day 6: 6mg |
|
| G-CSF | Drug | Starting from the 9th day, if the white blood cell count is less than 20,000/μL, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed. |
|
| CHOP | Combination Product | [Cyclophosphamide (Cy) + Doxorubicin (ADM) + Vincristine (VDS) + Prednisone (Pred) ]± Rituximab (R) |
|
| Hyper-CVAD | Combination Product | [Cyclophosphamide + Doxorubicin + Vincristine + Dexamethasone (DXM)] ± Rituximab |
|
| ID-MTX + Ara-C | Combination Product | [High-Dose Methotrexate (MTX) + Cytarabine] ± Rituximab |
|
| DA-EPOCH | Combination Product | [Etoposide + Doxorubicin + Vincristine + Cyclophosphamide + Prednisone] ± Rituximab |
|
| GDP | Combination Product | [Gemcitabine (G) + Cisplatin (P) + Dexamethasone (DXM)] ± Rituximab |
|
| GDPE | Combination Product | [Gemcitabine + Cisplatin + Dexamethasone + Etoposide] ± Rituximab |
|
| ICE | Combination Product | [Etoposide + Ifosfamide (IFO) + Carboplatin] ± Rituximab |
|
| DICE | Combination Product | [Dexamethasone + Ifosfamide + Ifosfamide + Etoposide] ± Rituximab |
|
| G-CSF | Drug | From Day 6, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed. |
|
| CD34+ cells and the average number of collections |
To observe and compare the total cumulative collection of CD34+ cells and the average number of collections between the EAP regimen and the disease-specific chemotherapy regimen. |
| 1 month |
| Adverse Rvents (AEs) | To observe and compare the hematological and non-hematological adverse reactions between the EAP regimen and the disease-specific chemotherapy regimen. | 1 month |
| % of patients who use Plerixafor | To observe and compare the proportion of patients who receive plerixafor added to the EAP regimen and the disease-specific chemotherapy regimen. | 1 month |
| The Affiliated Hangzhou First People's Hospital | Recruiting | Hangzhou | Zhejiang | 310006 | China |
|
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | China |
|
| Tongde Hospital of Zhejiang Province | Recruiting | Hangzhou | Zhejiang | China |
|
| Huzhou central hospital | Recruiting | Huzhou | Zhejiang | China |
|
| The First Hospital of Jiaxing | Recruiting | Jiaxing | Zhejiang | China |
|
| Jinhua Municipal Central Hospital | Recruiting | Jinhua | Zhejiang | China |
|
| Jinhua People's Hospital | Recruiting | Jinhua | Zhejiang | China |
|
| Lishui Central Hospital | Recruiting | Lishui | Zhejiang | China |
|
| Ningbo Medical Center Lihuili Hospital | Recruiting | Ningbo | Zhejiang | China |
|
| The Affiliated People's Hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | China |
|
| Shaoxing People's Hospital | Recruiting | Shaoxing | Zhejiang | China |
|
| Shaoxing Second Hospital | Recruiting | Shaoxing | Zhejiang | China |
|
| Taizhou Central Hospital | Recruiting | Taizhou | Zhejiang | China |
|
| Taizhou Hospital of Zhejiang Province | Recruiting | Taizhou | Zhejiang | China |
|
| The Second Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | China |
|
| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | China |
|
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| D003561 | Cytarabine |
| C423652 | pegylated granulocyte colony-stimulating factor |
| D016179 | Granulocyte Colony-Stimulating Factor |
| C064396 | CVAD protocol |
| C079446 | EPOCH protocol |
| D006153 | Guanosine Diphosphate |
| C037357 | 1-(1-glycero)dodeca-1,3,5,7,9-pentaene |
| D007053 | Ice |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| 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 |
| D006150 | Guanine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009711 | Nucleotides |
| D012265 | Ribonucleotides |
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D014887 | Weather |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
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