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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат Etoposide
  Day 1\~Day 2: 75mg/m\^2
• Препарат Cytarabine
  Day 1\~Day 2: 200g/m\^2, q12h
• Препарат PEG-rhG-CSF
  Day 6: 6mg
• Препарат 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.
• Комбинированный продукт CHOP
  \[Cyclophosphamide (Cy) + Doxorubicin (ADM) + Vincristine (VDS) + Prednisone (Pred) \]± Rituximab (R)
• Комбинированный продукт Hyper-CVAD
  \[Cyclophosphamide + Doxorubicin + Vincristine + Dexamethasone (DXM)\] ± Rituximab
• Комбинированный продукт ID-MTX + Ara-C
  \[High-Dose Methotrexate (MTX) + Cytarabine\] ± Rituximab
• Комбинированный продукт DA-EPOCH
  \[Etoposide + Doxorubicin + Vincristine + Cyclophosphamide + Prednisone\] ± Rituximab
• Комбинированный продукт GDP
  \[Gemcitabine (G) + Cisplatin (P) + Dexamethasone (DXM)\] ± Rituximab
• Комбинированный продукт GDPE
  \[Gemcitabine + Cisplatin + Dexamethasone + Etoposide\] ± Rituximab

Первичные конечные точки

• % of patients achieving the collection of ≥5×10^6 CD34+ cells/kg [Срок оценки: 1 month]

Вторичные конечные точки (4)

• % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg [Срок оценки: 1 month]
• CD34+ cells and the average number of collections [Срок оценки: 1 month]
• Adverse Rvents (AEs) [Срок оценки: 1 month]
• % of patients who use Plerixafor [Срок оценки: 1 month]

Критерии участия

Критерии включения

• 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 complete remission after multiple courses of chemotherapy.
• Life expectancy ≥ 3 months.
• Subjects must be able to understand the protocol and sign the informed consent.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 17 центров

• Dongyang People's Hospital — Dongyang
• The Affiliated Hangzhou First People's Hospital — Ханчжоу
• The First Affiliated Hospital, College of Medicine, Zhejiang University — Ханчжоу
• Tongde Hospital of Zhejiang Province — Ханчжоу
• Huzhou central hospital — Huzhou
• The First Hospital of Jiaxing — Jiaxing
• Jinhua Municipal Central Hospital — Jinhua
• Jinhua People's Hospital — Jinhua
• … и ещё 9 центров

Идентификаторы

NCT: NCT06520163 · 2024-059

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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