Etoposide+Cytarabine+PEG-rhG-CSF for Hematopoietic Stem Cell Mobilization 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) 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.

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) on Hematopoietic Stem Cell Mobilization in Poor Mobilization Patients With Hematological Malignancies

Conditions
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Hematological Malignancy

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: 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

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>* D1 D2: 75mg/m^2<br>* Other names: VP-16;Drug: Cytarabine<br>* D1 D2: 300mg/m^2, q12h<br>* Other names: Ara-C;Drug: PEG-rhG-CSF<br>* D6: 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 regimen |  | 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