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Non-Hodgkin's LymphomaPhase 3NCT06520163

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

A Phase 3 study testing Etoposide, Cytarabine and PEG-rhG-CSF in people with Non-Hodgkin's Lymphoma and Hematopoietic Stem Cell Mobilization, run by The Affiliated People's Hospital of Ningbo University at 17 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Etoposide, Cytarabine and PEG-rhG-CSF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
17 sitesChina
Study dates
1 Aug 2024to Aug 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Peipei Ye contact

86-13685832706

39612903@qq.com

Ying Lu contact

86-13486090834

814871416@qq.com

17 sites in 1 country

China17 sites, 17 recruiting

  • Dongyang People's Hospital

    Dongyang, Zhejiang

    Gongqiang Wu, 13757950788, Wugongqiang59@126.com

    Recruiting

  • The Affiliated Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 310006

    Xiangmin Tong, +86-13750816623, tongxiangmin@163.com

    Recruiting

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang

    Jie Jin, 13507016779, jiej0503@163.com

    Recruiting

  • Tongde Hospital of Zhejiang Province

    Hangzhou, Zhejiang

    Huifang Jiang, 13957182087, Jianghuifang501@163.com

    Recruiting

  • Huzhou central hospital

    Huzhou, Zhejiang

    Lihong Shou, 13587206019, SLH077@126.COM

    Recruiting

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang

    Hui Zeng, 13957330440, zhwuhan@163.com

    Recruiting

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang

    Jingcheng Zhang, 13958480529, zjc1983@126.com

    Recruiting

  • Jinhua People's Hospital

    Jinhua, Zhejiang

    Li Huang, 13566782316, huanglixiaoyu@126.com

    Recruiting

  • Lishui Central Hospital

    Lishui, Zhejiang

    Linjie Li, 13567615761, Lilinjie0394@163.com

    Recruiting

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang

    Jing Le, 13566511755, nblejing@aliyun.com

    Recruiting

  • The Affiliated People's Hospital of Ningbo University

    Ningbo, Zhejiang

    Peipei Ye, 13685832706, 39612903@qq.com

    Ying Lu, 13486090834, 814871416@qq.com

    Recruiting

  • Shaoxing People's Hospital

    Shaoxing, Zhejiang

    Weiying Feng, 13588570250, fengweiying1997@126.com

    Recruiting

  • Shaoxing Second Hospital

    Shaoxing, Zhejiang

    Weiguo Zhu, 18767509030, yin990216@sina.com

    Recruiting

  • Taizhou Central Hospital

    Taizhou, Zhejiang

    Sai Chen, 13575809591, chens7111@tzzxyy.com

    Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang

    Qunyi Guo, 13515861286, guoqunyi@163.com

    Recruiting

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Ying Lin, 13705883857, wzly1974@hotmail.com

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou

    Shujuan Zhou, 13738368586, Zhousj320@163.com

    Recruiting

Other trials in China

About this study

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

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).

Read the 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.

Being tested
Etoposide, Cytarabine, PEG-rhG-CSF, G-CSF, CHOP
Keywords
Non-Hodgkin's Lymphoma, Disease-Specific Chemotherapy, Hematopoietic stem cell mobilization, Etoposide, Cytarabine Combined with PEG-rhG-CSF
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtoposideDrug

    Also called VP-16

    Day 1~Day 2: 75mg/m^2

  • CytarabineDrug

    Also called Ara-C

    Day 1~Day 2: 200g/m^2, q12h

  • PEG-rhG-CSFDrug

    Day 6: 6mg

  • G-CSFDrug

    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.

  • CHOPCombination product

    [Cyclophosphamide (Cy) + Doxorubicin (ADM) + Vincristine (VDS) + Prednisone (Pred) ]± Rituximab (R)

  • Hyper-CVADCombination product

    [Cyclophosphamide + Doxorubicin + Vincristine + Dexamethasone (DXM)] ± Rituximab

  • ID-MTX + Ara-CCombination product

    [High-Dose Methotrexate (MTX) + Cytarabine] ± Rituximab

  • DA-EPOCHCombination product

    [Etoposide + Doxorubicin + Vincristine + Cyclophosphamide + Prednisone] ± Rituximab

  • GDPCombination product

    [Gemcitabine (G) + Cisplatin (P) + Dexamethasone (DXM)] ± Rituximab

  • GDPECombination product

    [Gemcitabine + Cisplatin + Dexamethasone + Etoposide] ± Rituximab

  • ICECombination product

    [Etoposide + Ifosfamide (IFO) + Carboplatin] ± Rituximab

  • DICECombination product

    [Dexamethasone + Ifosfamide + Ifosfamide + Etoposide] ± Rituximab

  • G-CSFDrug

    From Day 6, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.

Study groups in NCT06520163
Study groupRoleWhat they receive
EAP regimen groupExperimental66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy.
Receives: Drug: Etoposide; Drug: Cytarabine; Drug: PEG-rhG-CSF; Drug: G-CSF
Disease-specific chemotherapy mobilization regimens groupActive comparator33 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. % 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.

    Measured: 1 month

Secondary outcomes (4)

  1. % 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.

    Measured: 1 month

  2. 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.

    Measured: 1 month

  3. Adverse Rvents (AEs)

    To observe and compare the hematological and non-hematological adverse reactions between the EAP regimen and the disease-specific chemotherapy regimen.

    Measured: 1 month

  4. % 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.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2024
  2. Study start1 Aug 2024
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, two-arm, multicenter, exploratory study
Masking
None (open label)
Enrolment
99 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06520163
Sponsor's protocol ID
2024-059
Status last verified
Oct 2025
First submitted
20 Jul 2024
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etoposide, Cytarabine and PEG-rhG-CSF in people with Non-Hodgkin's Lymphoma and Hematopoietic Stem Cell Mobilization, run by The Affiliated People's Hospital of Ningbo University at 17 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Peipei Ye (86-13685832706, 39612903@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% of patients achieving the collection of ≥5×10^6 CD34+ cells/kg (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06520163.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

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