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

The Affiliated People's Hospital of Ningbo University

Status and phase: Enrolling; Phase 3

Conditions: Non-Hodgkin's Lymphoma; Hematopoietic Stem Cell Mobilization

Treatments: Drug: Etoposide; Drug: PEG-rhG-CSF; Combination Product: GDP; Combination Product: DA-EPOCH; Drug: G-CSF; Combination Product: ICE; Combination Product: ID-MTX + Ara-C; Combination Product: GDPE; Combination Product: CHOP; Combination Product: DICE; Combination Product: Hyper-CVAD; Drug: Cytarabine

Study type: Interventional

Funder types: Other

Identifiers

NCT06520163

2024-059

Details and patient eligibility

About

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).

Full 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.

Enrollment: 99 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

EAP regimen group

Experimental group

Description:

66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy.

Treatment:

Drug: Cytarabine

Drug: G-CSF

Drug: G-CSF

Drug: PEG-rhG-CSF

Drug: Etoposide

Disease-specific chemotherapy mobilization regimens group

Active Comparator group

Description:

33 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.

Treatment:

Combination Product: Hyper-CVAD

Combination Product: DICE

Combination Product: CHOP

Combination Product: GDPE

Combination Product: ID-MTX + Ara-C

Combination Product: ICE

Drug: G-CSF

Combination Product: DA-EPOCH

Drug: G-CSF

Combination Product: GDP