Status:
RECRUITING
Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma
Lead Sponsor:
The Affiliated People's Hospital of Ningbo University
Collaborating Sponsors:
First Affiliated Hospital of Zhejiang University
First Affiliated Hospital of Wenzhou Medical University
Conditions:
Non-Hodgkin's Lymphoma
Hematopoietic Stem Cell Mobilization
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study utilizes a prospective, multicenter, randomized two-arm design to evaluate the efficacy and safety of the etoposide, cytarabine, and pegylated recombinant human granulocyte colony-stimulati...
Detailed Description
Based on strict inclusion and exclusion criteria, a total of 99 non-Hodgkin's lymphoma patients from 16 hospitals will be selected. Eligible subjects will be randomly assigned in a 2:1 ratio to either...
Eligibility Criteria
Inclusion
- Diagnosed with non-Hodgkin's lymphoma before enrollment.
- Indication for autologous stem cell transplantation (ASCT).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1.
- Achieved complete remission after multiple courses of chemotherapy.
- Life expectancy ≥ 3 months.
- Subjects must be able to understand the protocol and sign the informed consent.
Exclusion
- Cardiac function class II or higher or cardiac ejection fraction \< 40%.
- Serum direct bilirubin (DBIL) more than twice of the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than three times the upper limit of normal (ULN).
- Serum creatinine clearance rate ≤ 50%.
- Patients with active infection.
- History of prior hematopoietic stem cell mobilization.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT06520163
Start Date
August 1 2024
End Date
August 1 2026
Last Update
December 4 2025
Active Locations (17)
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1
Dongyang People's Hospital
Dongyang, Zhejiang, China
2
The Affiliated Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310006
3
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
4
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, China