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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Affiliated People's Hospital of Ningbo University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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