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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
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Combination product, Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Diagnosed with non-Hodgkin's lymphoma before enrollment.
• Indication for autologous stem cell transplantation (ASCT).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0\
• Achieved complete remission after multiple courses of chemotherapy.
• Life expectancy ≥ 3 months.
• Subjects must be able to understand the protocol and sign the informed consent.
Locations
Other Locations
China
Dongyang People's Hospital
RECRUITING
Dongyang
The Affiliated Hangzhou First People's Hospital
RECRUITING
Hangzhou
The First Affiliated Hospital, College of Medicine, Zhejiang University
RECRUITING
Hangzhou
Tongde Hospital of Zhejiang Province
RECRUITING
Hangzhou
Huzhou central hospital
RECRUITING
Huzhou
The First Hospital of Jiaxing
RECRUITING
Jiaxing
Jinhua Municipal Central Hospital
RECRUITING
Jinhua
Jinhua People's Hospital
RECRUITING
Jinhua
Lishui Central Hospital
RECRUITING
Lishui
Ningbo Medical Center Lihuili Hospital
RECRUITING
Ningbo
The Affiliated People's Hospital of Ningbo University
RECRUITING
Ningbo
Shaoxing People's Hospital
RECRUITING
Shaoxing
Shaoxing Second Hospital
RECRUITING
Shaoxing
Taizhou Central Hospital
RECRUITING
Taizhou
Taizhou Hospital of Zhejiang Province
RECRUITING
Taizhou
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
The Second Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Contact Information
Primary
Peipei Ye
39612903@qq.com
86-13685832706
Backup
Ying Lu
814871416@qq.com
86-13486090834
Time Frame
Start Date:2024-08-01
Estimated Completion Date:2026-08
Participants
Target number of participants:99
Treatments
Experimental: EAP regimen group
66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy.
Active_comparator: Disease-specific chemotherapy mobilization regimens group
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.
Collaborators: Shaoxing Second Hospital, Huzhou Central Hospital, Dongyang People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital, Shaoxing People's Hospital, Jinhua Municipal Central Hospital, Second Affiliated Hospital of Wenzhou Medical University, Taizhou Hospital, First Affiliated Hospital of Zhejiang University, Jinhua People's Hospital, Zhejiang Provincial Tongde Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Affiliated Hospital of Jiaxing University, The Central Hospital of Lishui City
Leads: The Affiliated People's Hospital of Ningbo University