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

Registration Number
NCT06520163
Lead Sponsor
The Affiliated People's Hospital of Ningbo University
Brief 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 NH...

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 recombina...

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
99
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 partial or better response after multiple courses of chemotherapy.
  • Life expectancy ≥ 3 months.
  • Subjects must be able to understand the protocol and sign the informed consent.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
EAP regimen groupG-CSF66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy.
EAP regimen groupCytarabine66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy.
EAP regimen groupEtoposide66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy.
EAP regimen groupPEG-rhG-CSF66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy.
Disease-specific chemotherapy mobilization regimens groupCHOP33 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.
Disease-specific chemotherapy mobilization regimens groupHyper-CVAD33 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.
Disease-specific chemotherapy mobilization regimens groupID-MTX + Ara-C33 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.
Disease-specific chemotherapy mobilization regimens groupDA-EPOCH33 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.
Disease-specific chemotherapy mobilization regimens groupGDPE33 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.
Disease-specific chemotherapy mobilization regimens groupICE33 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.
Disease-specific chemotherapy mobilization regimens groupDICE33 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.
Disease-specific chemotherapy mobilization regimens groupGDP33 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.
Disease-specific chemotherapy mobilization regimens groupG-CSF33 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.
Primary Outcome Measures
NameTimeMethod
% of patients achieving the collection of ≥5×10^6 CD34+ cells/kg1 month

Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10\^6/kg) after a single collection.

Secondary Outcome Measures
NameTimeMethod
% of patients achieving the collection of ≥2×10^6 CD34+ cells/kg1 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.

Adverse Rvents (AEs)1 month

To observe and compare the hematological and non-hematological adverse reactions between the EAP regimen and the disease-specific chemotherapy regimen.

CD34+ cells and the average number of collections1 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.

% of patients who use Plerixafor1 month

To observe and compare the proportion of patients who receive plerixafor added to the EAP regimen and the disease-specific chemotherapy regimen.

Trial Locations

Locations (16)

The First Affiliated Hospital, College of Medicine, Zhejiang University

🇨🇳

Hangzhou, Zhejiang, China

Lishui Central Hospital

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Lishui, Zhejiang, China

Dongyang People's Hospital

🇨🇳

Dongyang, Zhejiang, China

Huzhou central hospital

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Huzhou, Zhejiang, China

Jinhua People's Hospital

🇨🇳

Jinhua, Zhejiang, China

Tongde Hospital of Zhejiang Province

🇨🇳

Hangzhou, Zhejiang, China

The First Hospital of Jiaxing

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Jiaxing, Zhejiang, China

Shaoxing People's Hospital

🇨🇳

Shaoxing, Zhejiang, China

Ningbo Medical Center Lihuili Hospital

🇨🇳

Ningbo, Zhejiang, China

Taizhou Central Hospital

🇨🇳

Taizhou, Zhejiang, China

Shaoxing Second Hospital

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Shaoxing, Zhejiang, China

The Second Affiliated Hospital of Wenzhou Medical University

🇨🇳

Wenzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

🇨🇳

Taizhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

🇨🇳

Wenzhou, China

Jinhua Municipal Central Hospital

🇨🇳

Jinhua, Zhejiang, China

The Affiliated People's Hospital of Ningbo University

🇨🇳

Ningbo, Zhejiang, China

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