Etoposide+Cytarabine+PEG-rhG-CSF for Hematopoietic Stem Cell Mobilization in Patients With Hematological Malignancies

Sponsor

The Affiliated People's Hospital of Ningbo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05510089

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematological Malignancy	Drug: Etoposide Drug: Cytarabine Drug: PEG-rhG-CSF	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EAP regimen The combination regimen of etoposide, cytarabine and PEG-rhG-CSF.	Drug: Etoposide D1~D2: 75mg/m^2 Other Names: VP-16 Drug: Cytarabine D1~D2: 300g/m^2, q12h Other Names: Ara-C Drug: PEG-rhG-CSF D6: 6mg

Arm

Intervention/Treatment

Experimental: EAP regimen

The combination regimen of etoposide, cytarabine and PEG-rhG-CSF.

Drug: Etoposide

D1~D2: 75mg/m^2

Other Names:

VP-16

Drug: Cytarabine

D1~D2: 300g/m^2, q12h

Other Names:

Ara-C

Drug: PEG-rhG-CSF

D6: 6mg

Outcome Measures

Primary Outcome Measures

% of patients achieving the collection of ≥2×10^6 CD34+ cells/kg. [4 weeks]
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.

Secondary Outcome Measures

% of patients achieving the collection of >5×10^6 CD34+ cells/kg. [4 weeks]
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.
TRAEs [4 weeks]
Incidence and severity of treatment related adverse events (TRAEs). Adverse events will be collected based on NCI CTCAE version 5.0.
Time from PEG-rhG-CSF mobilization to HSC collection. [4 weeks]
To determine the time period from PEG-rhG-CSF mobilization to successfully collection of HSC.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

According to the diagnostic criteria of the Italian transplantation working group, patients with hematological malignancies 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