Trial Title:
Etoposide+Cytarabine+PEG-rhG-CSF as First Line Mobilization Regimen of Hematopoietic Stem Cells in Patients With Hematological Malignancies
NCT ID:
NCT05536154
Condition:
Lymphoma
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
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:
Day 1~Day 2: 75mg/m^2
Arm group label:
EAP regimen
Other name:
VP-16
Intervention type:
Drug
Intervention name:
Cytarabine
Description:
Day 1~Day 2: 200mg/m^2, q12h
Arm group label:
EAP regimen
Other name:
Ara-C
Intervention type:
Drug
Intervention name:
PEG-rhG-CSF
Description:
Day 6: 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) as
first line mobilization regimen of hematopoietic stem cells in patients with lymphoma and
multiple myeloma. 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.
Detailed description:
In patients older than 65 years, or with creatinine >2.5 mg/dL but with an endogenous
creatinine clearance >50%, the dose of etoposide and Ara-C should be reduced by
one-quarter to one-third.
Routinely blood analyses and peripheral blood CD34+ cells monitored will be performed
daily from day 9 to the end of HSC collection or the abandonment of HSC collection. If
the WBC count is ≤10×109/L, 5μg/kg/d of G-CSF should be injected subcutaneously until the
end of HSC collection.
Leukapheresis can be performed when the white blood cell counts recover (WBC count
was≥4×109/L) following chemotherapy and the CD34+ cell count was≥20/μL. Leukapheresis
started if the peripheral blood CD34+ counts plateaued at ≥5 cells/μL and <20 cells/μL
after recovery of white blood cell counts following chemotherapy, the clinician decided
whether to add plerixafor based on the specific situation of the patient. Leukapheresis
should be abandoned if the peak circulating CD34+ cells were <5/μL up to 20 days after
chemotherapy. CD34+ cells were determined by multi-parameter flow cytometry and a
dual-platform approach. Two blood cell separators were used at the study sites:
Spectra-Optia Apheresis system (Terumo BCT, Lake-wood, CO, USA) , COM.TEC (Fresenius
Kabi). During each leukapheresis, 2.5 times the patients' blood volume (±25%) had to be
processed within 5 h.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients diagnosed as lymphoma or multiple myeloma, with auto-HSCT indication.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.
3. Life expectancy ≥ 3 months.
4. Subjects must be able to understand the protocol and be willing to enroll the study,
sign the informed consent, and be able to comply with the study and follow-up
procedures.
Exclusion Criteria:
1. Patients with severe cardiac, hepatic or renal insufficiency, such as:
- Serum direct bilirubin (DBIL)>2× upper limit of normal (ULN);
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2× ULN;
- Serum creatinine clearance rate≤50%;
- Cardiac function class II or higher or severe arrhythmia.
2. History of hematopoietic stem cell mobilization.
3. Patients with active infection.
4. Female subjects who are pregnant or lactating.
5. Subjects with any life-threatening disease, medical condition or organ system
dysfunction compromising their safety or causing unnecessary risks for the study
results in the investigator' opinion, such as unstable heart disease, stroke,
rheumatoid arthritis, lupus.
6. Have received live vaccine and attenuated live vaccine within 4 weeks before
enrollment.
7. History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF.
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 Yu
Phone:
+86-13750853563
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 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 Li
Phone:
+86-13567615761
Email:
Lilinjie0394@163.com
Facility:
Name:
The Affiliated People's Hospital of Ningbo University
Address:
City:
Ningbo
Zip:
315040
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Lu
Phone:
+8613486090834
Email:
814871416@qq.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:
Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University
Address:
City:
Shaoxing
Zip:
312000
Country:
China
Status:
Recruiting
Contact:
Last name:
Weiying 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 Zhu
Phone:
+86-18767509030
Email:
yin990216@sina.com
Facility:
Name:
Taizhou Hospital of Zhejiang Province
Address:
City:
Taizhou
Zip:
317099
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Shen
Phone:
+86-13758628257
Email:
hyperlool@126.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:
The 2nd School of Medicine,WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
Address:
City:
Wenzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Lin
Phone:
13705883857
Email:
wzly1974@hotmail.com
Start date:
November 1, 2022
Completion date:
October 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/NCT05536154
