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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05536154
• Other study ID #: 2022-YAN-030
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• 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) 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.

Description:

In patients older than 65 years, or with creatinine >2.5 mg/dL but with an endogenous creatinine clearance >50%, the dose of etoposide and Ara-C should be reduced by one-quarter to one-third. Routinely blood analyses and peripheral blood CD34+ cells monitored will be performed daily from day 9 to the end of HSC collection or the abandonment of HSC collection. If the WBC count is ≤10×109/L, 5μg/kg/d of G-CSF should be injected subcutaneously until the end of HSC collection. Leukapheresis can be performed when the white blood cell counts recover (WBC count was≥4×109/L) following chemotherapy and the CD34+ cell count was≥20/μL. Leukapheresis started if the peripheral blood CD34+ counts plateaued at ≥5 cells/μL and <20 cells/μL after recovery of white blood cell counts following chemotherapy, the clinician decided whether to add plerixafor based on the specific situation of the patient. Leukapheresis should be abandoned if the peak circulating CD34+ cells were <5/μL up to 20 days after chemotherapy. CD34+ cells were determined by multi-parameter flow cytometry and a dual-platform approach. Two blood cell separators were used at the study sites: Spectra-Optia Apheresis system (Terumo BCT, Lake-wood, CO, USA) , COM.TEC (Fresenius Kabi). During each leukapheresis, 2.5 times the patients' blood volume (±25%) had to be processed within 5 h.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: October 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients diagnosed as lymphoma or multiple myeloma, with auto-HSCT indication.

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

3. Life expectancy = 3 months.

4. 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:

1. 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.

2. History of hematopoietic stem cell mobilization.

3. Patients with active infection.

4. Female subjects who are pregnant or lactating.

5. 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.

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

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Lymphoma
• Multiple Myeloma
• Neoplasms

Intervention

Drug:
• Etoposide
Day 1~Day 2: 75mg/m^2
• Cytarabine
Day 1~Day 2: 200mg/m^2, q12h
• PEG-rhG-CSF
Day 6: 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	Ningbo Medical Center Lihuili Hospital	Ningbo	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
China	The 2nd School of Medicine,WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU	Wenzhou	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 scheme		4 weeks
Secondary	Hematopoietic reconstitution and therapeutic adverse events after transplantation		4 weeks