Trial Title:
Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma
NCT ID:
NCT06520163
Condition:
Non-Hodgkin's Lymphoma
Hematopoietic Stem Cell Mobilization
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Cytarabine
Etoposide
Lenograstim
Conditions: Keywords:
Non-Hodgkin's Lymphoma
Disease-Specific Chemotherapy
Hematopoietic stem cell mobilization
Etoposide, Cytarabine Combined with PEG-rhG-CSF
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Prospective, randomized, two-arm, multicenter, exploratory study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Etoposide
Description:
Day 1~Day 2: 75mg/m^2
Arm group label:
EAP regimen group
Other name:
VP-16
Intervention type:
Drug
Intervention name:
Cytarabine
Description:
Day 1~Day 2: 200g/m^2, q12h
Arm group label:
EAP regimen group
Other name:
Ara-C
Intervention type:
Drug
Intervention name:
PEG-rhG-CSF
Description:
Day 6: 6mg
Arm group label:
EAP regimen group
Intervention type:
Drug
Intervention name:
G-CSF
Description:
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.
Arm group label:
EAP regimen group
Intervention type:
Combination Product
Intervention name:
CHOP
Description:
[Cyclophosphamide (Cy) + Doxorubicin (ADM) + Vincristine (VDS) + Prednisone (Pred) ]±
Rituximab (R)
Arm group label:
Disease-specific chemotherapy mobilization regimens group
Intervention type:
Combination Product
Intervention name:
Hyper-CVAD
Description:
[Cyclophosphamide + Doxorubicin + Vincristine + Dexamethasone (DXM)] ± Rituximab
Arm group label:
Disease-specific chemotherapy mobilization regimens group
Intervention type:
Combination Product
Intervention name:
ID-MTX + Ara-C
Description:
[High-Dose Methotrexate (MTX) + Cytarabine] ± Rituximab
Arm group label:
Disease-specific chemotherapy mobilization regimens group
Intervention type:
Combination Product
Intervention name:
DA-EPOCH
Description:
[Etoposide + Doxorubicin + Vincristine + Cyclophosphamide + Prednisone] ± Rituximab
Arm group label:
Disease-specific chemotherapy mobilization regimens group
Intervention type:
Combination Product
Intervention name:
GDP
Description:
[Gemcitabine (G) + Cisplatin (P) + Dexamethasone (DXM)] ± Rituximab
Arm group label:
Disease-specific chemotherapy mobilization regimens group
Intervention type:
Combination Product
Intervention name:
GDPE
Description:
[Gemcitabine + Cisplatin + Dexamethasone + Etoposide] ± Rituximab
Arm group label:
Disease-specific chemotherapy mobilization regimens group
Intervention type:
Combination Product
Intervention name:
ICE
Description:
[Etoposide + Ifosfamide (IFO) + Carboplatin] ± Rituximab
Arm group label:
Disease-specific chemotherapy mobilization regimens group
Intervention type:
Combination Product
Intervention name:
DICE
Description:
[Dexamethasone + Ifosfamide + Ifosfamide + Etoposide] ± Rituximab
Arm group label:
Disease-specific chemotherapy mobilization regimens group
Intervention type:
Drug
Intervention name:
G-CSF
Description:
From Day 6, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the
collection is completed.
Arm group label:
Disease-specific chemotherapy mobilization regimens group
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).
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
recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF), while the control
group will receive disease-specific chemotherapy mobilization regimens, such as the CHOP
and Hyper-CVAD. Subsequently, the number of CD34+ cells will be monitored. The study will
evaluate the proportion of patients achieving the ideal collection value after a single
collection (CD34+ cells ≥5×106/kg); the proportion of patients achieving the target
collection value cumulatively; the total amount of CD34+ cells collected and the average
number of collections; hematological and non-hematological adverse reactions; and the
proportion of patients receiving plerixafor.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Dongyang People's Hospital
Address:
City:
Dongyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Gongqiang Wu
Phone:
13757950788
Email:
Wugongqiang59@126.com
Facility:
Name:
The First Affiliated Hospital, College of Medicine, Zhejiang University
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Jin
Phone:
13507016779
Email:
jiej0503@163.com
Facility:
Name:
Tongde Hospital of Zhejiang Province
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Huifang Jiang
Phone:
13957182087
Email:
Jianghuifang501@163.com
Facility:
Name:
Huzhou central hospital
Address:
City:
Huzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Lihong Shou
Phone:
13587206019
Email:
SLH077@126.COM
Facility:
Name:
The First Hospital of Jiaxing
Address:
City:
Jiaxing
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Zeng
Phone:
13957330440
Email:
zhwuhan@163.com
Facility:
Name:
Jinhua Municipal Central Hospital
Address:
City:
Jinhua
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingcheng Zhang
Phone:
13958480529
Email:
zjc1983@126.com
Facility:
Name:
Jinhua People's Hospital
Address:
City:
Jinhua
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Huang
Phone:
13566782316
Email:
huanglixiaoyu@126.com
Facility:
Name:
Lishui Central Hospital
Address:
City:
Lishui
Country:
China
Status:
Recruiting
Contact:
Last name:
Linjie Li
Phone:
13567615761
Email:
Lilinjie0394@163.com
Facility:
Name:
Ningbo Medical Center Lihuili Hospital
Address:
City:
Ningbo
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Le
Phone:
13566511755
Email:
nblejing@aliyun.com
Facility:
Name:
The Affiliated People's Hospital of Ningbo University
Address:
City:
Ningbo
Country:
China
Status:
Recruiting
Contact:
Last name:
Peipei Ye
Phone:
13685832706
Email:
39612903@qq.com
Contact backup:
Last name:
Ying Lu
Phone:
13486090834
Email:
814871416@qq.com
Facility:
Name:
Shaoxing People's Hospital
Address:
City:
Shaoxing
Country:
China
Status:
Recruiting
Contact:
Last name:
Weiying Feng
Phone:
13588570250
Email:
fengweiying1997@126.com
Facility:
Name:
Shaoxing Second Hospital
Address:
City:
Shaoxing
Country:
China
Status:
Recruiting
Contact:
Last name:
Weiguo Zhu
Phone:
18767509030
Email:
yin990216@sina.com
Facility:
Name:
Taizhou Central Hospital
Address:
City:
Taizhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Sai Chen
Phone:
13575809591
Email:
chens7111@tzzxyy.com
Facility:
Name:
Taizhou Hospital of Zhejiang Province
Address:
City:
Taizhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Qunyi Guo
Phone:
13515861286
Email:
guoqunyi@163.com
Facility:
Name:
The Second Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Lin
Phone:
13705883857
Email:
wzly1974@hotmail.com
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Shujuan Zhou
Phone:
13738368586
Email:
Zhousj320@163.com
Start date:
August 2024
Completion date:
December 2026
Lead sponsor:
Agency:
The Affiliated People's Hospital of Ningbo University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Zhejiang University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Wenzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Jinhua People's Hospital
Agency class:
Other
Collaborator:
Agency:
The Central Hospital of Lishui City
Agency class:
Other
Collaborator:
Agency:
Shaoxing People's Hospital
Agency class:
Other
Collaborator:
Agency:
Shaoxing Second Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang Provincial Tongde Hospital
Agency class:
Other
Collaborator:
Agency:
Taizhou Hospital
Agency class:
Other
Collaborator:
Agency:
Dongyang People's Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of Jiaxing University
Agency class:
Other
Collaborator:
Agency:
Huizhou Municipal Central Hospital
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital of Wenzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Ningbo Medical Center Lihuili Hospital
Agency class:
Other
Collaborator:
Agency:
Jinhua Municipal Central Hospital
Agency class:
Other
Source:
The Affiliated People's Hospital of Ningbo University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06520163
