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

November 27, 2025 updated by: The Affiliated People's Hospital of Ningbo University

A Prospective, Multicenter, Randomized Controlled Trial Comparing the Efficacy and Safety of Etoposide, Cytarabine, and PEG-rhG-CSF Combination Therapy vs. Disease-Specific Chemotherapy for Hematopoietic Stem Cell Mobilization in Lymphoma

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 the experimental group or the control group. The experimental group will receive the EAP regimen, which combines etoposide, cytarabine, and pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF), while the control group will receive disease-specific chemotherapy mobilization regimens, such as the CHOP and Hyper-CVAD. Subsequently, the number of CD34+ cells will be monitored. The study will evaluate the proportion of patients achieving the ideal collection value after a single collection (CD34+ cells ≥5×106/kg); the proportion of patients achieving the target collection value cumulatively; the total amount of CD34+ cells collected and the average number of collections; hematological and non-hematological adverse reactions; and the proportion of patients receiving plerixafor.

Study Type

Interventional

Enrollment (Estimated)

99

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Wenzhou, China
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
    • Zhejiang
      • Dongyang, Zhejiang, China
        • Recruiting
        • Dongyang People's Hospital
        • Contact:
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital, College of Medicine, Zhejiang University
        • Contact:
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Tongde Hospital of Zhejiang Province
        • Contact:
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • The Affiliated Hangzhou First People's Hospital
        • Contact:
      • Huzhou, Zhejiang, China
        • Recruiting
        • Huzhou Central Hospital
        • Contact:
      • Jiaxing, Zhejiang, China
        • Recruiting
        • The First Hospital of Jiaxing
        • Contact:
      • Jinhua, Zhejiang, China
        • Recruiting
        • Jinhua Municipal Central Hospital
        • Contact:
      • Jinhua, Zhejiang, China
        • Recruiting
        • Jinhua People's Hospital
        • Contact:
      • Lishui, Zhejiang, China
        • Recruiting
        • Lishui Central Hospital
        • Contact:
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo medical center lihuili hospital
        • Contact:
      • Ningbo, Zhejiang, China
        • Recruiting
        • The Affiliated People's Hospital of Ningbo University
        • Contact:
        • Contact:
      • Shaoxing, Zhejiang, China
        • Recruiting
        • Shaoxing Second Hospital
        • Contact:
      • Shaoxing, Zhejiang, China
        • Recruiting
        • Shaoxing People's Hospital
        • Contact:
      • Taizhou, Zhejiang, China
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
      • Taizhou, Zhejiang, China
        • Recruiting
        • Taizhou Central Hospital
        • Contact:
      • Wenzhou, Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EAP regimen group
66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy.
Drug: Etoposide
Day 1~Day 2: 75mg/m^2
Other Names:
  • VP-16
Drug: PEG-rhG-CSF
Day 6: 6mg
Drug: Cytarabine
Day 1~Day 2: 200g/m^2, q12h
Other Names:
  • Ara-C
Drug: G-CSF
Starting from the 9th day, if the white blood cell count is less than 20,000/μL, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.
Drug: G-CSF
From Day 6, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.
Active Comparator: Disease-specific chemotherapy mobilization regimens group
33 subjects will be enrolled into the disease-specific chemotherapy mobilization regimens group. The disease-specific chemotherapy mobilization regimens include but not limited to: CHOP, Hyper-CVAD, ID-MTX+Ara-C.
Drug: G-CSF
Starting from the 9th day, if the white blood cell count is less than 20,000/μL, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.
Drug: G-CSF
From Day 6, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.
Combination product: CHOP
[Cyclophosphamide (Cy) + Doxorubicin (ADM) + Vincristine (VDS) + Prednisone (Pred) ]± Rituximab (R)
Combination product: Hyper-CVAD
[Cyclophosphamide + Doxorubicin + Vincristine + Dexamethasone (DXM)] ± Rituximab
Combination product: ID-MTX + Ara-C
[High-Dose Methotrexate (MTX) + Cytarabine] ± Rituximab
Combination product: DA-EPOCH
[Etoposide + Doxorubicin + Vincristine + Cyclophosphamide + Prednisone] ± Rituximab
Combination product: GDP
[Gemcitabine (G) + Cisplatin (P) + Dexamethasone (DXM)] ± Rituximab
Combination product: GDPE
[Gemcitabine + Cisplatin + Dexamethasone + Etoposide] ± Rituximab
Combination product: ICE
[Etoposide + Ifosfamide (IFO) + Carboplatin] ± Rituximab
Combination product: DICE
[Dexamethasone + Ifosfamide + Ifosfamide + Etoposide] ± Rituximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients achieving the collection of ≥5×10^6 CD34+ cells/kg
Time Frame: 1 month
Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10^6/kg) after a single collection.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients achieving the collection of ≥2×10^6 CD34+ cells/kg
Time Frame: 1 month
To observe and compare the proportion of patients who cumulatively achieve the target collection value (CD34+ cells ≥ 2×10^6/kg) between the EAP regimen and the disease-specific chemotherapy regimen; the proportion of patients who achieve the ideal collection value.
1 month
CD34+ cells and the average number of collections
Time Frame: 1 month
To observe and compare the total cumulative collection of CD34+ cells and the average number of collections between the EAP regimen and the disease-specific chemotherapy regimen.
1 month
Adverse Rvents (AEs)
Time Frame: 1 month
To observe and compare the hematological and non-hematological adverse reactions between the EAP regimen and the disease-specific chemotherapy regimen.
1 month
% of patients who use Plerixafor
Time Frame: 1 month
To observe and compare the proportion of patients who receive plerixafor added to the EAP regimen and the disease-specific chemotherapy regimen.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated People's Hospital of Ningbo University

Collaborators

Ningbo Medical Center Lihuili Hospital
First Affiliated Hospital of Zhejiang University
Jinhua People's Hospital
Second Affiliated Hospital of Wenzhou Medical University
Jinhua Municipal Central Hospital
The Central Hospital of Lishui City
First Affiliated Hospital of Wenzhou Medical University
Shaoxing People's Hospital
Shaoxing Second Hospital
Taizhou Hospital
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Zhejiang Provincial Tongde Hospital
Dongyang People's Hospital
Affiliated Hospital of Jiaxing University
Huzhou Central Hospital

Investigators

  • Principal Investigator: Peipei Ye, The Affiliated People's Hospital of Ningbo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 20, 2024

First Submitted That Met QC Criteria

July 20, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-059

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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