Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06520163

Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma

Led by The Affiliated People's Hospital of Ningbo University · Updated on 2025-12-04

99

Participants Needed

17

Research Sites

104 weeks

Total Duration

On this page

Sponsors

T

The Affiliated People's Hospital of Ningbo University

Lead Sponsor

F

First Affiliated Hospital of Zhejiang University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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-stimulating factor (PEG-rhG-CSF) combination therapy (EAP regimen) in mobilizing hematopoietic stem cells in patients with non-Hodgkin's lymphoma (NHL). A total of 99 NHL patients will be enrolled as research subjects and will be randomly allocated in a 2:1 ratio to compare the EAP regimen versus disease-specific chemotherapy mobilization regimen. The primary endpoint is the proportion of patients achieving the ideal collection value after a single collection (CD34+ cells ≥5×10\^6/kg).

CONDITIONS

Official Title

Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with non-Hodgkin's lymphoma before enrollment
  • Indication for autologous stem cell transplantation (ASCT)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Achieved complete remission after multiple chemotherapy courses
  • Life expectancy of at least 3 months
  • Able to understand the protocol and sign informed consent
Not Eligible

You will not qualify if you...

  • Cardiac function class II or higher or cardiac ejection fraction less than 40%
  • Serum direct bilirubin more than twice the upper limit of normal
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than three times the upper limit of normal
  • Serum creatinine clearance rate less than or equal to 50%
  • Active infection
  • History of prior hematopoietic stem cell mobilization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

Dongyang People's Hospital

Dongyang, Zhejiang, China

Actively Recruiting

2

The Affiliated Hangzhou First People's Hospital

Hangzhou, Zhejiang, China, 310006

Actively Recruiting

3

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Actively Recruiting

4

Tongde Hospital of Zhejiang Province

Hangzhou, Zhejiang, China

Actively Recruiting

5

Huzhou central hospital

Huzhou, Zhejiang, China

Actively Recruiting

6

The First Hospital of Jiaxing

Jiaxing, Zhejiang, China

Actively Recruiting

7

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, China

Actively Recruiting

8

Jinhua People's Hospital

Jinhua, Zhejiang, China

Actively Recruiting

9

Lishui Central Hospital

Lishui, Zhejiang, China

Actively Recruiting

10

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

Actively Recruiting

11

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China

Actively Recruiting

12

Shaoxing People's Hospital

Shaoxing, Zhejiang, China

Actively Recruiting

13

Shaoxing Second Hospital

Shaoxing, Zhejiang, China

Actively Recruiting

14

Taizhou Central Hospital

Taizhou, Zhejiang, China

Actively Recruiting

15

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Actively Recruiting

16

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Actively Recruiting

17

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Actively Recruiting

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Research Team

P

Peipei Ye

CONTACT

Y

Ying Lu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma | DecenTrialz