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

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT05536154

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

6.7

Patients Per Site

0.2

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) 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma Multiple Myeloma	Drug: Etoposide Drug: Cytarabine Drug: PEG-rhG-CSF	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

47 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) as First Line Mobilization Regimen of Hematopoietic Stem Cells in Patients With Hematological Malignancies

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EAP regimen The combination regimen of etoposide, cytarabine and PEG-rhG-CSF.	Drug: Etoposide Day 1~Day 2: 75mg/m^2 Other Names: VP-16 Drug: Cytarabine Day 1~Day 2: 300g/m^2, q12h Other Names: Ara-C Drug: PEG-rhG-CSF Day 6: 6mg

Arm

Intervention/Treatment

Experimental: EAP regimen

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

Drug: Etoposide

Day 1~Day 2: 75mg/m^2

Other Names:

VP-16

Drug: Cytarabine

Day 1~Day 2: 300g/m^2, q12h

Other Names:

Ara-C

Drug: PEG-rhG-CSF

Day 6: 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310024
2	Jinhua People's Hospital	Jinhua	Zhejiang	China	321099
3	Lishui Municipal Central Hospital	Lishui	Zhejiang	China	323000
4	The Affiliated People's Hospital of Ningbo University	Ningbo	Zhejiang	China	315040
5	Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University	Shaoxing	Zhejiang	China	312000
6	Shaoxing Second Hospital	Shaoxing	Zhejiang	China	312099
7	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang	China	317099