Clinical trial NCT06520163: Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-Hodgkin's Lymphoma
Hematopoietic Stem Cell Mobilization
Keywords: Non-Hodgkin's Lymphoma
Disease-Specific Chemotherapy
Hematopoietic stem cell mobilization
Etoposide, Cytarabine Combined with PEG-rhG-CSF
Lead sponsor: The Affiliated People's Hospital of Ningbo University
Sponsor class: OTHER_GOV
Collaborators: name: First Affiliated Hospital of Zhejiang University
name: First Affiliated Hospital of Wenzhou Medical University
name: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
name: Jinhua People's Hospital
name: The Central Hospital of Lishui City
name: Shaoxing People's Hospital
name: Shaoxing Second Hospital
name: Zhejiang Provincial Tongde Hospital
name: Taizhou Hospital
name: Dongyang People's Hospital
name: Affiliated Hospital of Jiaxing University
name: Huizhou Municipal Central Hospital
name: Second Affiliated Hospital of Wenzhou Medical University
name: Ningbo Medical Center Lihuili Hospital
name: Jinhua Municipal Central Hospital
First posted: 2024-07-25
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, two-arm, multicenter, exploratory study
Primary purpose: TREATMENT

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 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: 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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: % of patients achieving the collection of ≥5×10^6 CD34+ cells/kg
timeFrame: 1 month
Secondary outcomes:
measure: % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg
timeFrame: 1 month
measure: CD34+ cells and the average number of collections
timeFrame: 1 month
measure: Adverse Rvents (AEs)
timeFrame: 1 month
measure: % of patients who use Plerixafor
timeFrame: 1 month
Other outcomes:
Locations:
city: Dongyang
country: China
facility: Dongyang People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Tongde Hospital of Zhejiang Province
state: Zhejiang
city: Huzhou
country: China
facility: Huzhou central hospital
state: Zhejiang
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua People's Hospital
state: Zhejiang
city: Lishui
country: China
facility: Lishui Central Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The Affiliated People's Hospital of Ningbo University
state: Zhejiang
city: Shaoxing
country: China
facility: Shaoxing People's Hospital
state: Zhejiang
city: Shaoxing
country: China
facility: Shaoxing Second Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Central Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
Study officials:
affiliation: The Affiliated People's Hospital of Ningbo University
name: Peipei Ye
role: PRINCIPAL_INVESTIGATOR
References: