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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05510089
Other study ID # 2022-YAN-019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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