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

NCT ID: NCT06520163

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-08-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Non-Hodgkin's Lymphoma Hematopoietic Stem Cell Mobilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, two-arm, multicenter, exploratory study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Etoposide

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

PEG-rhG-CSF

Intervention Type DRUG

Day 6: 6mg

G-CSF

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

CHOP

Intervention Type COMBINATION_PRODUCT

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

Hyper-CVAD

Intervention Type COMBINATION_PRODUCT

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

ID-MTX + Ara-C

Intervention Type COMBINATION_PRODUCT

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

DA-EPOCH

Intervention Type COMBINATION_PRODUCT

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

GDP

Intervention Type COMBINATION_PRODUCT

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

GDPE

Intervention Type COMBINATION_PRODUCT

\[Gemcitabine + Cisplatin + Dexamethasone + Etoposide\] ± Rituximab

ICE

Intervention Type COMBINATION_PRODUCT

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

DICE

Intervention Type COMBINATION_PRODUCT

\[Dexamethasone + Ifosfamide + Ifosfamide + Etoposide\] ± Rituximab

G-CSF

Intervention Type DRUG

From Day 6, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.

Interventions

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Etoposide

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

Intervention Type DRUG

Cytarabine

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

Intervention Type DRUG

PEG-rhG-CSF

Day 6: 6mg

Intervention Type 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.

Intervention Type DRUG

CHOP

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

Intervention Type COMBINATION_PRODUCT

Hyper-CVAD

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

Intervention Type COMBINATION_PRODUCT

ID-MTX + Ara-C

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

Intervention Type COMBINATION_PRODUCT

DA-EPOCH

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

Intervention Type COMBINATION_PRODUCT

GDP

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

Intervention Type COMBINATION_PRODUCT

GDPE

\[Gemcitabine + Cisplatin + Dexamethasone + Etoposide\] ± Rituximab

Intervention Type COMBINATION_PRODUCT

ICE

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

Intervention Type COMBINATION_PRODUCT

DICE

\[Dexamethasone + Ifosfamide + Ifosfamide + Etoposide\] ± Rituximab

Intervention Type COMBINATION_PRODUCT

G-CSF

From Day 6, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.

Intervention Type DRUG

Other Intervention Names

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VP-16 Ara-C

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

OTHER

Sponsor Role collaborator

Jinhua People's Hospital

OTHER

Sponsor Role collaborator

The Central Hospital of Lishui City

OTHER

Sponsor Role collaborator

Shaoxing People's Hospital

OTHER

Sponsor Role collaborator

Shaoxing Second Hospital

OTHER

Sponsor Role collaborator

Zhejiang Provincial Tongde Hospital

OTHER

Sponsor Role collaborator

Taizhou Hospital

OTHER

Sponsor Role collaborator

Dongyang People's Hospital

OTHER

Sponsor Role collaborator

Affiliated Hospital of Jiaxing University

OTHER

Sponsor Role collaborator

Huzhou Central Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Ningbo Medical Center Lihuili Hospital

OTHER_GOV

Sponsor Role collaborator

Jinhua Municipal Central Hospital

OTHER

Sponsor Role collaborator

The Affiliated People's Hospital of Ningbo University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peipei Ye

Role: PRINCIPAL_INVESTIGATOR

The Affiliated People's Hospital of Ningbo University

Locations

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Dongyang People's Hospital

Dongyang, Zhejiang, China

Site Status RECRUITING

The Affiliated Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Tongde Hospital of Zhejiang Province

Hangzhou, Zhejiang, China

Site Status RECRUITING

Huzhou central hospital

Huzhou, Zhejiang, China

Site Status RECRUITING

The First Hospital of Jiaxing

Jiaxing, Zhejiang, China

Site Status RECRUITING

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, China

Site Status RECRUITING

Jinhua People's Hospital

Jinhua, Zhejiang, China

Site Status RECRUITING

Lishui Central Hospital

Lishui, Zhejiang, China

Site Status RECRUITING

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

Site Status RECRUITING

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China

Site Status RECRUITING

Shaoxing People's Hospital

Shaoxing, Zhejiang, China

Site Status RECRUITING

Shaoxing Second Hospital

Shaoxing, Zhejiang, China

Site Status RECRUITING

Taizhou Central Hospital

Taizhou, Zhejiang, China

Site Status RECRUITING

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Site Status RECRUITING

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Peipei Ye

Role: CONTACT

86-13685832706

Ying Lu

Role: CONTACT

86-13486090834

Facility Contacts

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Gongqiang Wu

Role: primary

13757950788

Xiangmin Tong

Role: primary

+86-13750816623

Jie Jin

Role: primary

13507016779

Huifang Jiang

Role: primary

13957182087

Lihong Shou

Role: primary

13587206019

Hui Zeng

Role: primary

13957330440

Jingcheng Zhang

Role: primary

13958480529

Li Huang

Role: primary

13566782316

Linjie Li

Role: primary

13567615761

Jing Le

Role: primary

13566511755

Peipei Ye

Role: primary

13685832706

Ying Lu

Role: backup

13486090834

Weiying Feng

Role: primary

13588570250

Weiguo Zhu

Role: primary

18767509030

Sai Chen

Role: primary

13575809591

Qunyi Guo

Role: primary

13515861286

Ying Lin

Role: primary

13705883857

Shujuan Zhou

Role: primary

13738368586

Other Identifiers

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2024-059

Identifier Type: -

Identifier Source: org_study_id

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