Trial Title:
Etoposide+Cytarabine+PEG-rhG-CSF for Hematopoietic Stem Cell Mobilization in Patients With Hematological Malignancies
NCT ID:
NCT05510089
Condition:
Hematological Malignancy
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Cytarabine
Etoposide
Conditions: Keywords:
Etoposide
Cytarabine
PEG-rhG-CSF
Hematological Malignancies
Hematopoietic Stem Cell Mobilization
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Etoposide
Description:
D1~D2: 75mg/m^2
Arm group label:
EAP regimen
Other name:
VP-16
Intervention type:
Drug
Intervention name:
Cytarabine
Description:
D1~D2: 300mg/m^2, q12h
Arm group label:
EAP regimen
Other name:
Ara-C
Intervention type:
Drug
Intervention name:
PEG-rhG-CSF
Description:
D6: 6mg
Arm group label:
EAP regimen
Summary:
This is a single-arm, multicenter, exploratory clinical study to evaluate the safety and
efficacy of the combination of etoposide, cytarabine and PEG-rhG-CSF (EAP regimen) on
hematopoietic stem cell mobilization in poor mobilization patients with hematological
malignancies. All eligible patients will receive EAP regimen treatment, then the number
of CD34+ cells and white blood cells will be monitoring. When the collection standard is
met, hematopoietic stem cell collection will be started.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. According to the diagnostic criteria of the Italian transplantation working group,
patients with multiple myeloma or lymphoma diagnosed as "confirmed poor
mobilization" or "predicted poor mobilization".
2. Patients with auto-HSCT indication.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.
4. Patients should be within age range of ≥18 and ≤75 years old.
5. Life expectancy ≥ 3 months.
6. Patients must be able to sign informed consent.
Exclusion Criteria:
1. Patients with severe cardiac, hepatic or renal insufficiency, such as:
- Cardiac function class II or higher or severe arrhythmia;
- Serum direct bilirubin (DBIL)>2× upper limit of normal (ULN);
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2× ULN;
- Serum creatinine clearance rate≤50%.
2. Patients with active infection.
3. History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF.
4. Women who are pregnant or breastfeeding.
5. Have received live vaccine and attenuated live vaccine within 4 weeks before
enrollment.
6. For any other reasons, the patients are believed not suitable for participation in
this study by investigators
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:
Tongde Hospital of Zhejiang Province
Address:
City:
Hangzhou
Zip:
310012
Country:
China
Status:
Recruiting
Contact:
Last name:
Huifang Jiang
Phone:
+86-13957182087
Email:
jianghuifang501@163.com
Facility:
Name:
The First Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310024
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenjuan O Yu
Phone:
+8613750853563
Email:
drwjyu@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:
Jinhua Municipal Central Hospital
Address:
City:
Jinhua
Zip:
321000
Country:
China
Status:
Recruiting
Contact:
Last name:
Huixian Hu
Phone:
+86-13588652288
Email:
huhuixian@zju.edu.cn
Facility:
Name:
Jinhua People's Hospital
Address:
City:
Jinhua
Zip:
321099
Country:
China
Status:
Recruiting
Contact:
Last name:
Li P Huang
Phone:
+86-13566782316
Email:
huanglixiaoyu@126.com
Facility:
Name:
Lishui Municipal Central Hospital
Address:
City:
Lishui
Zip:
323000
Country:
China
Status:
Recruiting
Contact:
Last name:
Linjie C Li
Phone:
+86-13567615761
Email:
Lilinjie0394@163.com
Facility:
Name:
The Affiliated People's Hospital of Ningbo University.
Address:
City:
Ningbo
Zip:
315101
Country:
China
Status:
Recruiting
Contact:
Last name:
Peipei Ye
Phone:
86-0574-87016871
Email:
39612903@qq.com
Facility:
Name:
Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University
Address:
City:
Shaoxing
Zip:
312000
Country:
China
Status:
Recruiting
Contact:
Last name:
Weiying Z Feng
Phone:
+86-13588570250
Email:
fengweiying1997@126.com
Facility:
Name:
Shaoxing Second Hospital
Address:
City:
Shaoxing
Zip:
312099
Country:
China
Status:
Recruiting
Contact:
Last name:
Weiguo S Zhu
Phone:
+86-18767509030
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:
Jian Z Shen
Phone:
+86-13758628257
Email:
hyperlool@126.com
Start date:
September 1, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
The Affiliated People's Hospital of Ningbo University
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/NCT05510089
