Etoposide+Cytarabine+PEG-rhG-CSF as First Line Mobilization Regimen of Hematopoietic Stem Cells in Patients With Hematological Malignancies

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lymphoma, Multiple Myeloma

Intervention / Treatment
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* Drug: Etoposide
* Drug: Cytarabine
* Drug: PEG-rhG-CSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. Have received hematopoietic stem cell mobilization.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EAP regimen<br>The combination regimen of etoposide, cytarabine and PEG-rhG-CSF. | Drug: Etoposide<br>* Day 1 Day 2: 75mg/m^2<br>* Other names: VP-16;Drug: Cytarabine<br>* Day 1 Day 2: 200mg/m^2, q12h<br>* Other names: Ara-C;Drug: PEG-rhG-CSF<br>* Day 6: 6mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % 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. | 4 weeks | 
| TRAEs | Incidence and severity of treatment related adverse events (TRAEs). Adverse events will be collected based on NCI CTCAE version 5.0. | 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. | 4 weeks | 
| The average collection times of EAP scheme |  | 4 weeks | 
| Hematopoietic reconstitution and therapeutic adverse events after transplantation |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Etoposide, Cytarabine, PEG-rhG-CSF, Hematological Malignancies, Hematopoietic Stem Cell Mobilization