A Phase 3 interventional study of Etoposide and Cytarabine in Non-Hodgkin's Lymphoma and Hematopoietic Stem Cell Mobilization, sponsored by The Affiliated People's Hospital of Ningbo University. Recruiting at 17 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by The Affiliated People's Hospital of Ningbo University · Phase 3, Interventional, and Treatment
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).
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.
2,287 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 287 are open to participants now.
This study's planned enrollment of 99 is above the median of 40 across 1,883 interventional studies indexed under Lymphoma, Non-Hodgkin.
Browse Lymphoma, Non-Hodgkin studies →The Affiliated People's Hospital of Ningbo University is the lead sponsor of 10 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy.
Drug: Etoposide · Drug: Cytarabine · Drug: PEG-rhG-CSF · Drug: G-CSF
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.
Combination Product: CHOP · Combination Product: Hyper-CVAD · Combination Product: ID-MTX + Ara-C · Combination Product: DA-EPOCH · Combination Product: GDP · Combination Product: GDPE · Combination Product: ICE · Combination Product: DICE · Drug: G-CSF
Day 1\~Day 2: 75mg/m\^2
Also known as: VP-16
Day 1\~Day 2: 200g/m\^2, q12h
Also known as: Ara-C
Day 6: 6mg
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.
Drug pages: Cyclophosphamide · Doxorubicin · Vincristine · Prednisone
\[Cyclophosphamide (Cy) + Doxorubicin (ADM) + Vincristine (VDS) + Prednisone (Pred) \]± Rituximab (R)
\[Cyclophosphamide + Doxorubicin + Vincristine + Dexamethasone (DXM)\] ± Rituximab
Drug page: Cytarabine
\[High-Dose Methotrexate (MTX) + Cytarabine\] ± Rituximab
\[Etoposide + Doxorubicin + Vincristine + Cyclophosphamide + Prednisone\] ± Rituximab
\[Gemcitabine (G) + Cisplatin (P) + Dexamethasone (DXM)\] ± Rituximab
\[Gemcitabine + Cisplatin + Dexamethasone + Etoposide\] ± Rituximab
\[Etoposide + Ifosfamide (IFO) + Carboplatin\] ± Rituximab
\[Dexamethasone + Ifosfamide + Ifosfamide + Etoposide\] ± Rituximab
From Day 6, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.
% of patients achieving the collection of ≥5×10^6 CD34+ cells/kg
Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10\^6/kg) after a single collection.
Time frame: 1 month
% of patients achieving the collection of ≥2×10^6 CD34+ cells/kg
To observe and compare the proportion of patients who cumulatively achieve the target collection value (CD34+ cells ≥ 2×10\^6/kg) between the EAP regimen and the disease-specific chemotherapy regimen; the proportion of patients who achieve the ideal collection value.
Time frame: 1 month
CD34+ cells and the average number of collections
To observe and compare the total cumulative collection of CD34+ cells and the average number of collections between the EAP regimen and the disease-specific chemotherapy regimen.
Time frame: 1 month
Adverse Rvents (AEs)
To observe and compare the hematological and non-hematological adverse reactions between the EAP regimen and the disease-specific chemotherapy regimen.
Time frame: 1 month
% of patients who use Plerixafor
To observe and compare the proportion of patients who receive plerixafor added to the EAP regimen and the disease-specific chemotherapy regimen.
Time frame: 1 month
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Studies of the drugs tested here: Etoposide · Cytarabine · Pegylated granulocyte colony-stimulating factor
The Affiliated People's Hospital of Ningbo University