Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma
- Conditions
- Interventions
- Registration Number
- NCT06520163
- Brief 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 NH...
- Detailed Description
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 recombina...
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 99
- 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 partial or better response after multiple courses of chemotherapy.
- Life expectancy ≥ 3 months.
- Subjects must be able to understand the protocol and sign the informed consent.
- 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%.
- Patients with active infection.
- History of prior hematopoietic stem cell mobilization.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EAP regimen group G-CSF 66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy. EAP regimen group Cytarabine 66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy. EAP regimen group Etoposide 66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy. EAP regimen group PEG-rhG-CSF 66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy. Disease-specific chemotherapy mobilization regimens group CHOP 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. Disease-specific chemotherapy mobilization regimens group Hyper-CVAD 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. Disease-specific chemotherapy mobilization regimens group ID-MTX + Ara-C 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. Disease-specific chemotherapy mobilization regimens group DA-EPOCH 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. Disease-specific chemotherapy mobilization regimens group GDPE 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. Disease-specific chemotherapy mobilization regimens group ICE 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. Disease-specific chemotherapy mobilization regimens group DICE 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. Disease-specific chemotherapy mobilization regimens group GDP 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. Disease-specific chemotherapy mobilization regimens group G-CSF 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.
- Primary Outcome Measures
Name Time Method % of patients achieving the collection of ≥5×10^6 CD34+ cells/kg 1 month Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10\^6/kg) after a single collection.
- Secondary Outcome Measures
Name Time Method % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg 1 month 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.
Adverse Rvents (AEs) 1 month To observe and compare the hematological and non-hematological adverse reactions between the EAP regimen and the disease-specific chemotherapy regimen.
CD34+ cells and the average number of collections 1 month 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.
% of patients who use Plerixafor 1 month To observe and compare the proportion of patients who receive plerixafor added to the EAP regimen and the disease-specific chemotherapy regimen.
Trial Locations
- Locations (16)
The First Affiliated Hospital, College of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Lishui Central Hospital
🇨🇳Lishui, Zhejiang, China
Dongyang People's Hospital
🇨🇳Dongyang, Zhejiang, China
Huzhou central hospital
🇨🇳Huzhou, Zhejiang, China
Jinhua People's Hospital
🇨🇳Jinhua, Zhejiang, China
Tongde Hospital of Zhejiang Province
🇨🇳Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
🇨🇳Jiaxing, Zhejiang, China
Shaoxing People's Hospital
🇨🇳Shaoxing, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
🇨🇳Ningbo, Zhejiang, China
Taizhou Central Hospital
🇨🇳Taizhou, Zhejiang, China
Shaoxing Second Hospital
🇨🇳Shaoxing, Zhejiang, China
The Second Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, China
Jinhua Municipal Central Hospital
🇨🇳Jinhua, Zhejiang, China
The Affiliated People's Hospital of Ningbo University
🇨🇳Ningbo, Zhejiang, China