Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Etoposide, Cytarabine, PEG-rhG-CSF, G-CSF.
- Who it may be relevant to
- Registry conditions: Non-Hodgkin's Lymphoma, Hematopoietic Stem Cell Mobilization. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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
Primary outcome measures
- % of patients achieving the collection of ≥5×10^6 CD34+ cells/kg [Time frame: 1 month]
Secondary outcome measures (4)
- % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg [Time frame: 1 month]
- CD34+ cells and the average number of collections [Time frame: 1 month]
- Adverse Rvents (AEs) [Time frame: 1 month]
- % of patients who use Plerixafor [Time frame: 1 month]
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 complete remission 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 17 centers
- Dongyang People's Hospital — Dongyang
- The Affiliated Hangzhou First People's Hospital — Hangzhou
- The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou
- Tongde Hospital of Zhejiang Province — Hangzhou
- Huzhou central hospital — Huzhou
- The First Hospital of Jiaxing — Jiaxing
- Jinhua Municipal Central Hospital — Jinhua
- Jinhua People's Hospital — Jinhua
- … and 9 more centers
Identifiers
NCT: NCT06520163 · 2024-059