Back to resultsEtoposide+Cytarabine+PEG-rhG-CSF for Hematopoietic Stem Cell Mobilization in Patients With Hematological Malignancies
Primary Purpose
Hematological Malignancy
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Etoposide
Cytarabine
PEG-rhG-CSF
Sponsored by
About this trial
This is an interventional treatment trial for Hematological Malignancy focused on measuring Etoposide, Cytarabine, PEG-rhG-CSF, Hematological Malignancies, Hematopoietic Stem Cell Mobilization
Eligibility Criteria
Inclusion Criteria:
- According to the diagnostic criteria of the Italian transplantation working group, patients with hematological malignancies diagnosed as "confirmed poor mobilization" or "predicted poor mobilization".
- Patients with auto-HSCT indication.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.
- Patients should be within age range of ≥18 and ≤75 years old.
- Life expectancy ≥ 3 months.
- Patients must be able to sign informed consent.
Exclusion Criteria:
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%.
- Patients with active infection.
- History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF.
- Women who are pregnant or breastfeeding.
- Have received live vaccine and attenuated live vaccine within 4 weeks before enrollment.
- For any other reasons, the patients are believed not suitable for participation in this study by investigators
Sites / Locations
- Dongyang People's HospitalRecruiting
- Tongde Hospital of Zhejiang ProvinceRecruiting
- The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting
- Huzhou central hospitalRecruiting
- Jinhua Municipal Central HospitalRecruiting
- Jinhua People's HospitalRecruiting
- Lishui Municipal Central HospitalRecruiting
- The Affiliated People's Hospital of Ningbo University.Recruiting
- Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang UniversityRecruiting
- Shaoxing Second HospitalRecruiting
- Taizhou Central HospitalRecruiting
- Taizhou Hospital of Zhejiang ProvinceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EAP regimen
Arm Description
The combination regimen of etoposide, cytarabine and PEG-rhG-CSF.
Outcomes
Primary Outcome Measures
% of patients achieving the collection of ≥2×10^6 CD34+ cells/kg.
The proportion of patients whose cells can be successfully mobilized and collected with a target CD34+ Hematopoietic Stem Cell (HSC) dose of ≥2×10^6/kg.
Secondary Outcome Measures
% of patients achieving the collection of >5×10^6 CD34+ cells/kg.
The proportion of patients whose cells can be successfully mobilized and collected with a target CD34+ Hematopoietic Stem Cell (HSC) dose of >5×10^6/kg.
TRAEs
Incidence and severity of treatment related adverse events (TRAEs). Adverse events will be collected based on NCI CTCAE version 5.0.
Time from PEG-rhG-CSF mobilization to HSC collection.
To determine the time period from PEG-rhG-CSF mobilization to successfully collection of HSC.
The average collection times of EAP regimen
Hematopoietic reconstitution and therapeutic adverse events after transplantation
Full Information
NCT ID
NCT05510089
First Posted
August 18, 2022
Last Updated
October 6, 2023
Sponsor
The Affiliated People's Hospital of Ningbo University
1. Study Identification
Unique Protocol Identification Number
NCT05510089
Brief Title
Etoposide+Cytarabine+PEG-rhG-CSF for Hematopoietic Stem Cell Mobilization in Patients With Hematological Malignancies
Official Title
Prospective, Single-arm, Multicenter Exploratory Clinical Study of the Combination of Etoposide, Cytarabine and PEG-rhG-CSF (EAP Regimen) on Hematopoietic Stem Cell Mobilization in Poor Mobilization Patients With Hematological Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated People's Hospital of Ningbo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancy
Keywords
Etoposide, Cytarabine, PEG-rhG-CSF, Hematological Malignancies, Hematopoietic Stem Cell Mobilization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EAP regimen
Arm Type
Experimental
Arm Description
The combination regimen of etoposide, cytarabine and PEG-rhG-CSF.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
VP-16
Intervention Description
D1~D2: 75mg/m^2
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
Ara-C
Intervention Description
D1~D2: 300mg/m^2, q12h
Intervention Type
Drug
Intervention Name(s)
PEG-rhG-CSF
Intervention Description
D6: 6mg
Primary Outcome Measure Information:
Title
% of patients achieving the collection of ≥2×10^6 CD34+ cells/kg.
Description
The proportion of patients whose cells can be successfully mobilized and collected with a target CD34+ Hematopoietic Stem Cell (HSC) dose of ≥2×10^6/kg.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
% of patients achieving the collection of >5×10^6 CD34+ cells/kg.
Description
The proportion of patients whose cells can be successfully mobilized and collected with a target CD34+ Hematopoietic Stem Cell (HSC) dose of >5×10^6/kg.
Time Frame
4 weeks
Title
TRAEs
Description
Incidence and severity of treatment related adverse events (TRAEs). Adverse events will be collected based on NCI CTCAE version 5.0.
Time Frame
4 weeks
Title
Time from PEG-rhG-CSF mobilization to HSC collection.
Description
To determine the time period from PEG-rhG-CSF mobilization to successfully collection of HSC.
Time Frame
4 weeks
Title
The average collection times of EAP regimen
Time Frame
4 weeks
Title
Hematopoietic reconstitution and therapeutic adverse events after transplantation
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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".
Patients with auto-HSCT indication.
Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.
Patients should be within age range of ≥18 and ≤75 years old.
Life expectancy ≥ 3 months.
Patients must be able to sign informed consent.
Exclusion Criteria:
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%.
Patients with active infection.
History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF.
Women who are pregnant or breastfeeding.
Have received live vaccine and attenuated live vaccine within 4 weeks before enrollment.
For any other reasons, the patients are believed not suitable for participation in this study by investigators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Lu
Phone
86-13486090834
Email
814871416@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Peipei Ye
Phone
86-13685832706
Email
39612903@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Lu
Organizational Affiliation
The Affiliated People's Hospital of Ningbo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongyang People's Hospital
City
Dongyang
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gongqiang Wu
Phone
13757950788
Email
wugongqiang59@126.com
Facility Name
Tongde Hospital of Zhejiang Province
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huifang Jiang
Phone
+86-13957182087
Email
jianghuifang501@163.com
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310024
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjuan O Yu
Phone
+8613750853563
Email
drwjyu@163.com
Facility Name
Huzhou central hospital
City
Huzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihong Shou
Phone
13587206019
Email
SLH077@126.com
Facility Name
Jinhua Municipal Central Hospital
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
321000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huixian Hu
Phone
+86-13588652288
Email
huhuixian@zju.edu.cn
Facility Name
Jinhua People's Hospital
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
321099
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li P Huang
Phone
+86-13566782316
Email
huanglixiaoyu@126.com
Facility Name
Lishui Municipal Central Hospital
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linjie C Li
Phone
+86-13567615761
Email
Lilinjie0394@163.com
Facility Name
The Affiliated People's Hospital of Ningbo University.
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315101
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peipei Ye
Phone
86-0574-87016871
Email
39612903@qq.com
Facility Name
Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University
City
Shaoxing
State/Province
Zhejiang
ZIP/Postal Code
312000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiying Z Feng
Phone
+86-13588570250
Email
fengweiying1997@126.com
Facility Name
Shaoxing Second Hospital
City
Shaoxing
State/Province
Zhejiang
ZIP/Postal Code
312099
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiguo S Zhu
Phone
+86-18767509030
Email
yin990216@sina.com
Facility Name
Taizhou Central Hospital
City
Taizhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sai Chen
Phone
13575809591
Email
chens7111@tzzxyy.com
Facility Name
Taizhou Hospital of Zhejiang Province
City
Taizhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Z Shen
Phone
+86-13758628257
Email
hyperlool@126.com
12. IPD Sharing Statement
Learn more about this trial
Etoposide+Cytarabine+PEG-rhG-CSF for Hematopoietic Stem Cell Mobilization in Patients With Hematological Malignancies
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