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).
Diagnosed with non-Hodgkin's lymphoma before enrollment.
Indication for autologous stem cell transplantation (ASCT).
Eastern Cooperative Oncology Group (ECOG) performance status of 0~1.
Achieved complete remission after multiple courses of chemotherapy.
Cardiac function class II or higher or cardiac ejection fraction < 40%.
Serum direct bilirubin (DBIL) more than twice of the upper limit of normal (ULN).
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than three times the upper limit of normal (ULN).
Serum creatinine clearance rate ≤ 50%.
Parallel
Etoposide
DrugDay 1\~Day 2: 75mg/m\^2
Cytarabine
DrugDay 1\~Day 2: 200g/m\^2, q12h
PEG-rhG-CSF
DrugDay 6: 6mg
G-CSF
DrugStarting 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
DrugFrom Day 6, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.
% 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.
% 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.
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.
Adverse Rvents (AEs)
To observe and compare the hematological and non-hematological adverse reactions between the EAP regimen and the disease-specific chemotherapy regimen.
% 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.
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The Affiliated People's Hospital of Ningbo University
Lead sponsor
First Affiliated Hospital of Zhejiang University
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Collaborator
Jinhua People's Hospital
Collaborator
The Central Hospital of Lishui City
Collaborator
Shaoxing People's Hospital
Collaborator
Shaoxing Second Hospital
Collaborator
Zhejiang Provincial Tongde Hospital
Collaborator
Taizhou Hospital
Collaborator
Dongyang People's Hospital
Collaborator
Affiliated Hospital of Jiaxing University
Collaborator
Huzhou Central Hospital
Collaborator
Second Affiliated Hospital of Wenzhou Medical University
Collaborator
Ningbo Medical Center Lihuili Hospital
Collaborator
Jinhua Municipal Central Hospital
Collaborator
