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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
Day 1\~Day 2: 75mg/m\^2
Day 1\~Day 2: 200g/m\^2, q12h
Day 6: 6mg
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.
\[Cyclophosphamide (Cy) + Doxorubicin (ADM) + Vincristine (VDS) + Prednisone (Pred) \]± Rituximab (R)
\[Cyclophosphamide + Doxorubicin + Vincristine + Dexamethasone (DXM)\] ± Rituximab
\[High-Dose Methotrexate (MTX) + Cytarabine\] ± Rituximab
\[Etoposide + Doxorubicin + Vincristine + Cyclophosphamide + Prednisone\] ± Rituximab
\[Gemcitabine (G) + Cisplatin (P) + Dexamethasone (DXM)\] ± Rituximab
\[Gemcitabine + Cisplatin + Dexamethasone + Etoposide\] ± Rituximab
\[Etoposide + Ifosfamide (IFO) + Carboplatin\] ± Rituximab
\[Dexamethasone + Ifosfamide + Ifosfamide + Etoposide\] ± Rituximab
From Day 6, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.
Dongyang People's Hospital
Dongyang, Zhejiang, China
RECRUITINGThe Affiliated Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGThe First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGTongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, China
RECRUITINGHuzhou central hospital
Huzhou, Zhejiang, China
RECRUITINGThe First Hospital of Jiaxing
Jiaxing, Zhejiang, China
RECRUITINGJinhua Municipal Central Hospital
Jinhua, Zhejiang, China
RECRUITINGJinhua People's Hospital
Jinhua, Zhejiang, China
RECRUITINGLishui Central Hospital
Lishui, Zhejiang, China
RECRUITINGNingbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
RECRUITING...and 7 more locations
% 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.
Time frame: 1 month
% 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.
Time frame: 1 month
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month
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