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Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma
Sponsor: The Affiliated People's Hospital of Ningbo University
Summary
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).
Official title: A Prospective, Multicenter, Randomized Controlled Trial Comparing the Efficacy and Safety of Etoposide, Cytarabine, and PEG-rhG-CSF Combination Therapy vs. Disease-Specific Chemotherapy for Hematopoietic Stem Cell Mobilization in Lymphoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
99
Start Date
2024-08-01
Completion Date
2026-08
Last Updated
2025-12-04
Healthy Volunteers
No
Interventions
Etoposide
Day 1\~Day 2: 75mg/m\^2
Cytarabine
Day 1\~Day 2: 200g/m\^2, q12h
PEG-rhG-CSF
Day 6: 6mg
G-CSF
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
\[Cyclophosphamide (Cy) + Doxorubicin (ADM) + Vincristine (VDS) + Prednisone (Pred) \]± Rituximab (R)
Hyper-CVAD
\[Cyclophosphamide + Doxorubicin + Vincristine + Dexamethasone (DXM)\] ± Rituximab
ID-MTX + Ara-C
\[High-Dose Methotrexate (MTX) + Cytarabine\] ± Rituximab
DA-EPOCH
\[Etoposide + Doxorubicin + Vincristine + Cyclophosphamide + Prednisone\] ± Rituximab
GDP
\[Gemcitabine (G) + Cisplatin (P) + Dexamethasone (DXM)\] ± Rituximab
GDPE
\[Gemcitabine + Cisplatin + Dexamethasone + Etoposide\] ± Rituximab
ICE
\[Etoposide + Ifosfamide (IFO) + Carboplatin\] ± Rituximab
DICE
\[Dexamethasone + Ifosfamide + Ifosfamide + Etoposide\] ± Rituximab
G-CSF
From Day 6, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.
Locations (17)
Dongyang People's Hospital
Dongyang, Zhejiang, China
The Affiliated Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, China
Huzhou central hospital
Huzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China
Jinhua People's Hospital
Jinhua, Zhejiang, China
Lishui Central Hospital
Lishui, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, China
Shaoxing People's Hospital
Shaoxing, Zhejiang, China
Shaoxing Second Hospital
Shaoxing, Zhejiang, China
Taizhou Central Hospital
Taizhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China