NCT06520163

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: The Affiliated People's Hospital of Ningbo University · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2024-07-25
• Last updated: 2025-12-04

Locations

17 sites across 1 country: China