Etoposide+Cytarabine+PEG-rhG-CSF for Hematopoietic Stem Cell Mobilization in Patients With Hematological Malignancies
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
1 other identifier
interventional
62
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Typical duration for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2022
CompletedFirst Posted
Study publicly available on registry
August 22, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedOctober 10, 2023
August 1, 2023
1.7 years
August 18, 2022
October 6, 2023
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 regimen
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:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
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, 315101, China
Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University
Shaoxing, Zhejiang, 312000, China
Shaoxing Second Hospital
Shaoxing, Zhejiang, 312099, China
Taizhou Central Hospital
Taizhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, 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
August 18, 2022
First Posted
August 22, 2022
Study Start
September 1, 2022
Primary Completion
May 31, 2024
Study Completion
December 31, 2024
Last Updated
October 10, 2023
Record last verified: 2023-08