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RECRUITING
NCT06520163
PHASE3

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

Sponsor: The Affiliated People's Hospital of Ningbo University

View on ClinicalTrials.gov

Summary

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).

Official 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

99

Start Date

2024-08-01

Completion Date

2026-08

Last Updated

2025-12-04

Healthy Volunteers

No

Interventions

DRUG

Etoposide

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

DRUG

Cytarabine

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

DRUG

PEG-rhG-CSF

Day 6: 6mg

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.

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

DRUG

G-CSF

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

Locations (17)

Dongyang People's Hospital

Dongyang, Zhejiang, China

The Affiliated Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Tongde Hospital of Zhejiang Province

Hangzhou, Zhejiang, China

Huzhou central hospital

Huzhou, Zhejiang, China

The First Hospital of Jiaxing

Jiaxing, Zhejiang, China

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, China

Jinhua People's Hospital

Jinhua, Zhejiang, China

Lishui Central Hospital

Lishui, Zhejiang, China

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China

Shaoxing People's Hospital

Shaoxing, Zhejiang, China

Shaoxing Second Hospital

Shaoxing, Zhejiang, China

Taizhou Central Hospital

Taizhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China