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NCT Number: NCT06520163

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

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Key information

Conditions

Non-Hodgkin's Lymphoma Hematopoietic Stem Cell Mobilization Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dongyang People's Hospital, Dongyang, Zhejiang, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

etoposide

Drug

Day 1~Day 2: 75mg/m^2

Other names: VP-16

Cytarabine

Drug

Day 1~Day 2: 200g/m^2, q12h

Other names: Ara-C

PEG-rhG-CSF

Drug

Day 6: 6mg

G-CSF

Drug

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.

CHOP

Combination Product

[Cyclophosphamide (Cy) + Doxorubicin (ADM) + Vincristine (VDS) + Prednisone (Pred) ]± Rituximab (R)

Hyper-CVAD

Combination Product

[Cyclophosphamide + Doxorubicin + Vincristine + Dexamethasone (DXM)] ± Rituximab

ID-MTX + Ara-C

Combination Product

[High-Dose Methotrexate (MTX) + Cytarabine] ± Rituximab

DA-EPOCH

Combination Product

[Etoposide + Doxorubicin + Vincristine + Cyclophosphamide + Prednisone] ± Rituximab

GDP

Combination Product

[Gemcitabine (G) + Cisplatin (P) + Dexamethasone (DXM)] ± Rituximab

GDPE

Combination Product

[Gemcitabine + Cisplatin + Dexamethasone + Etoposide] ± Rituximab

ICE

Combination Product

[Etoposide + Ifosfamide (IFO) + Carboplatin] ± Rituximab

DICE

Combination Product

[Dexamethasone + Ifosfamide + Ifosfamide + Etoposide] ± Rituximab

Primary outcomes

  1. % 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.

Secondary outcomes

  1. % 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.

  2. 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.

  3. 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.

  4. % 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Peipei Ye

CONTACT

[email protected]

86-13685832706

Ying Lu

CONTACT

[email protected]

86-13486090834

Sponsors and collaborators

Lead sponsor

The Affiliated People's Hospital of Ningbo University

Other Gov

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2024
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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