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

Hematological Malignancy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05510089
• Other study ID #: 2022-YAN-019
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: The Affiliated People's Hospital of Ningbo University
• Contact: Ying Lu
• Phone: 86-13486090834
• Email: 814871416[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 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".

2. Patients with auto-HSCT indication.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.

4. Patients should be within age range of =18 and =75 years old.

5. Life expectancy = 3 months.

6. Patients must be able to sign informed consent.

Exclusion Criteria:

1. 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%.

2. Patients with active infection.

3. History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF.

4. Women who are pregnant or breastfeeding.

5. Have received live vaccine and attenuated live vaccine within 4 weeks before enrollment.

6. For any other reasons, the patients are believed not suitable for participation in this study by investigators

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancy
• Neoplasms

Intervention

Drug:
• Etoposide
D1~D2: 75mg/m^2
• Cytarabine
D1~D2: 300mg/m^2, q12h
• PEG-rhG-CSF
D6: 6mg

Locations

Country	Name	City	State
China	Dongyang People's Hospital	Dongyang	Zhejiang
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Tongde Hospital of Zhejiang Province	Hangzhou	Zhejiang
China	Huzhou central hospital	Huzhou	Zhejiang
China	Jinhua Municipal Central Hospital	Jinhua	Zhejiang
China	Jinhua People's Hospital	Jinhua	Zhejiang
China	Lishui Municipal Central Hospital	Lishui	Zhejiang
China	The Affiliated People's Hospital of Ningbo University.	Ningbo	Zhejiang
China	Shaoxing People's Hospital, Shaoxing Hospital of Zhejiang University	Shaoxing	Zhejiang
China	Shaoxing Second Hospital	Shaoxing	Zhejiang
China	Taizhou Central Hospital	Taizhou	Zhejiang
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated People's Hospital of Ningbo University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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	% 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
Secondary	TRAEs	Incidence and severity of treatment related adverse events (TRAEs). Adverse events will be collected based on NCI CTCAE version 5.0.	4 weeks
Secondary	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
Secondary	The average collection times of EAP regimen		4 weeks
Secondary	Hematopoietic reconstitution and therapeutic adverse events after transplantation		4 weeks