Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma
NCT Number: NCT06520163
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Non-Hodgkin's Lymphoma|Hematopoietic Stem Cell Mobilization
Interventions: DRUG: Etoposide|DRUG: Cytarabine|DRUG: PEG-rhG-CSF|DRUG: G-CSF|COMBINATION_PRODUCT: CHOP|COMBINATION_PRODUCT: Hyper-CVAD|COMBINATION_PRODUCT: ID-MTX + Ara-C|COMBINATION_PRODUCT: DA-EPOCH|COMBINATION_PRODUCT: GDP|COMBINATION_PRODUCT: GDPE|COMBINATION_PRODUCT: ICE|COMBINATION_PRODUCT: DICE|DRUG: G-CSF
Sponsor: The Affiliated People's Hospital of Ningbo University
Collaborators: First Affiliated Hospital of Zhejiang University|First Affiliated Hospital of Wenzhou Medical University|Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University|Jinhua People's Hospital|The Central Hospital of Lishui City|Shaoxing People's Hospital|Shaoxing Second Hospital|Zhejiang Provincial Tongde Hospital|Taizhou Hospital|Dongyang People's Hospital|Affiliated Hospital of Jiaxing University|Huizhou Municipal Central Hospital|Second Affiliated Hospital of Wenzhou Medical University|Ningbo Medical Center Lihuili Hospital|Jinhua Municipal Central Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 99
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-12
Locations: Dongyang People's Hospital, Dongyang, 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

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).

Primary Outcome Measures: % 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
Secondary Outcome Measures: % 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|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