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

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).

Conditions

• Non-Hodgkin's Lymphoma
• Hematopoietic Stem Cell Mobilization

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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  collaborator OTHER

• Jinhua People's Hospital

  collaborator OTHER

• The Central Hospital of Lishui City

  collaborator OTHER

• Shaoxing People's Hospital

  collaborator OTHER

• Shaoxing Second Hospital

  collaborator OTHER

• Zhejiang Provincial Tongde Hospital

  collaborator OTHER

• Taizhou Hospital

  collaborator OTHER

• Dongyang People's Hospital

  collaborator OTHER

• Affiliated Hospital of Jiaxing University

  collaborator OTHER

• Huzhou Central Hospital

  collaborator OTHER

• Second Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Ningbo Medical Center Lihuili Hospital

  collaborator OTHER_GOV

• Jinhua Municipal Central Hospital

  collaborator OTHER

• The Affiliated People's Hospital of Ningbo University

  lead OTHER_GOV

Principal Investigators

• Peipei Ye · The Affiliated People's Hospital of Ningbo University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-01

Primary Completion

2026-08-31

Completion

2026-08-31

Countries

• China

Study Locations