Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma
NCT ID: NCT06520163
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
99 participants
INTERVENTIONAL
2024-08-01
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EAP regimen group
66 subjects will be enrolled into the EAP regimen group. EAP regimen is the etoposide, cytarabine, and PEG-rhG-CSF combination therapy.
Etoposide
Day 1\~Day 2: 75mg/m\^2
Cytarabine
Day 1\~Day 2: 200g/m\^2, q12h
PEG-rhG-CSF
Day 6: 6mg
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.
Disease-specific chemotherapy mobilization regimens group
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.
CHOP
\[Cyclophosphamide (Cy) + Doxorubicin (ADM) + Vincristine (VDS) + Prednisone (Pred) \]± Rituximab (R)
Hyper-CVAD
\[Cyclophosphamide + Doxorubicin + Vincristine + Dexamethasone (DXM)\] ± Rituximab
ID-MTX + Ara-C
\[High-Dose Methotrexate (MTX) + Cytarabine\] ± Rituximab
DA-EPOCH
\[Etoposide + Doxorubicin + Vincristine + Cyclophosphamide + Prednisone\] ± Rituximab
GDP
\[Gemcitabine (G) + Cisplatin (P) + Dexamethasone (DXM)\] ± Rituximab
GDPE
\[Gemcitabine + Cisplatin + Dexamethasone + Etoposide\] ± Rituximab
ICE
\[Etoposide + Ifosfamide (IFO) + Carboplatin\] ± Rituximab
DICE
\[Dexamethasone + Ifosfamide + Ifosfamide + Etoposide\] ± Rituximab
G-CSF
From Day 6, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.
Interventions
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Etoposide
Day 1\~Day 2: 75mg/m\^2
Cytarabine
Day 1\~Day 2: 200g/m\^2, q12h
PEG-rhG-CSF
Day 6: 6mg
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.
CHOP
\[Cyclophosphamide (Cy) + Doxorubicin (ADM) + Vincristine (VDS) + Prednisone (Pred) \]± Rituximab (R)
Hyper-CVAD
\[Cyclophosphamide + Doxorubicin + Vincristine + Dexamethasone (DXM)\] ± Rituximab
ID-MTX + Ara-C
\[High-Dose Methotrexate (MTX) + Cytarabine\] ± Rituximab
DA-EPOCH
\[Etoposide + Doxorubicin + Vincristine + Cyclophosphamide + Prednisone\] ± Rituximab
GDP
\[Gemcitabine (G) + Cisplatin (P) + Dexamethasone (DXM)\] ± Rituximab
GDPE
\[Gemcitabine + Cisplatin + Dexamethasone + Etoposide\] ± Rituximab
ICE
\[Etoposide + Ifosfamide (IFO) + Carboplatin\] ± Rituximab
DICE
\[Dexamethasone + Ifosfamide + Ifosfamide + Etoposide\] ± Rituximab
G-CSF
From Day 6, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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First Affiliated Hospital of Zhejiang University
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
OTHER
Jinhua People's Hospital
OTHER
The Central Hospital of Lishui City
OTHER
Shaoxing People's Hospital
OTHER
Shaoxing Second Hospital
OTHER
Zhejiang Provincial Tongde Hospital
OTHER
Taizhou Hospital
OTHER
Dongyang People's Hospital
OTHER
Affiliated Hospital of Jiaxing University
OTHER
Huzhou Central Hospital
OTHER
Second Affiliated Hospital of Wenzhou Medical University
OTHER
Ningbo Medical Center Lihuili Hospital
OTHER_GOV
Jinhua Municipal Central Hospital
OTHER
The Affiliated People's Hospital of Ningbo University
OTHER_GOV
Responsible Party
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Principal Investigators
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Peipei Ye
Role: PRINCIPAL_INVESTIGATOR
The Affiliated People's Hospital of Ningbo University
Locations
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Dongyang People's Hospital
Dongyang, Zhejiang, China
The Affiliated Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, China
Huzhou central hospital
Huzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China
Jinhua People's Hospital
Jinhua, Zhejiang, China
Lishui Central Hospital
Lishui, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, China
Shaoxing People's Hospital
Shaoxing, Zhejiang, China
Shaoxing Second Hospital
Shaoxing, Zhejiang, China
Taizhou Central Hospital
Taizhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-059
Identifier Type: -
Identifier Source: org_study_id
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