Etoposide+Cytarabine+PEG-rhG-CSF as First Line Mobilization Regimen of Hematopoietic Stem Cells in Patients With Hematological Malignancies
Prospective, Single-arm, Multicenter Exploratory Clinical Study of the Combination of Etoposide, Cytarabine and PEG-rhG-CSF (EAP Regimen) as First Line Mobilization Regimen of Hematopoietic Stem Cells in Patients With Hematological Malignancies
1 other identifier
interventional
68
1 country
14
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) 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable lymphoma
Started Nov 2022
Shorter than P25 for not_applicable lymphoma
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2022
CompletedFirst Posted
Study publicly available on registry
September 10, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedMarch 19, 2024
March 1, 2024
1.6 years
September 7, 2022
March 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% 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.
4 weeks
Secondary Outcomes (5)
% of patients achieving the collection of #5×10^6 CD34+ cells/kg.
4 weeks
TRAEs
4 weeks
Time from PEG-rhG-CSF mobilization to HSC collection.
4 weeks
The average collection times of EAP scheme
4 weeks
Hematopoietic reconstitution and therapeutic adverse events after transplantation
4 weeks
Study Arms (1)
EAP regimen
EXPERIMENTALThe combination regimen of etoposide, cytarabine and PEG-rhG-CSF.
Interventions
Eligibility Criteria
You may qualify if:
- Patients diagnosed as lymphoma or multiple myeloma, with auto-HSCT indication.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0\~2.
- Life expectancy ≥ 3 months.
- 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.
You may not qualify if:
- 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.
- History of hematopoietic stem cell mobilization.
- Patients with active infection.
- Female subjects who are pregnant or lactating.
- 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.
- Have received live vaccine and attenuated live vaccine within 4 weeks before enrollment.
- History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Dongyang People's Hospital
Dongyang, Zhejiang, China
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, 310012, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310024, China
Huzhou central hospital
Huzhou, Zhejiang, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, 321000, China
Jinhua People's Hospital
Jinhua, Zhejiang, 321099, China
Lishui Municipal Central Hospital
Lishui, Zhejiang, 323000, China
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, 315040, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University
Shaoxing, Zhejiang, 312000, China
Shaoxing Second Hospital
Shaoxing, Zhejiang, 312099, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317099, China
Taizhou Central Hospital
Taizhou, Zhejiang, China
The 2nd School of Medicine,WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ying Lu
The Affiliated People's Hospital of Ningbo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2022
First Posted
September 10, 2022
Study Start
November 1, 2022
Primary Completion
June 1, 2024
Study Completion
October 1, 2024
Last Updated
March 19, 2024
Record last verified: 2024-03