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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
D1\~D2: 75mg/m\^2
D1\~D2: 300mg/m\^2, q12h
D6: 6mg
Dongyang People's Hospital
Dongyang, Zhejiang, China
RECRUITINGTongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, China
RECRUITINGThe First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGHuzhou central hospital
Huzhou, Zhejiang, China
RECRUITINGJinhua Municipal Central Hospital
Jinhua, Zhejiang, China
RECRUITINGJinhua People's Hospital
Jinhua, Zhejiang, China
RECRUITINGLishui Municipal Central Hospital
Lishui, Zhejiang, China
RECRUITINGThe Affiliated People's Hospital of Ningbo University.
Ningbo, Zhejiang, China
RECRUITINGShaoxing People's Hospital, Shaoxing Hospital of Zhejiang University
Shaoxing, Zhejiang, China
RECRUITINGShaoxing Second Hospital
Shaoxing, Zhejiang, China
RECRUITING...and 2 more locations
% 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.
Time frame: 4 weeks
% 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.
Time frame: 4 weeks
TRAEs
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
Time from PEG-rhG-CSF mobilization to HSC collection.
To determine the time period from PEG-rhG-CSF mobilization to successfully collection of HSC.
Time frame: 4 weeks
The average collection times of EAP regimen
Time frame: 4 weeks
Hematopoietic reconstitution and therapeutic adverse events after transplantation
Time frame: 4 weeks
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