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

NCT06520163 | Recruiting Phase 3 DMC

• 1 other identifier: 2024-059
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 17

Brief 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 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).

Conditions

Non-Hodgkin's Lymphoma; Hematopoietic Stem Cell Mobilization

Keywords

Non-Hodgkin's Lymphoma; Disease-Specific Chemotherapy; Hematopoietic stem cell mobilization; Etoposide, Cytarabine Combined with PEG-rhG-CSF

Outcome Measures

Primary Outcomes (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.

  1 month

Secondary Outcomes (4)

• % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg

  1 month

• CD34+ cells and the average number of collections

  1 month

• Adverse Rvents (AEs)

  1 month

• % of patients who use Plerixafor

  1 month

Study Arms (2)

EAP regimen group

EXPERIMENTAL

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

Disease-specific chemotherapy mobilization regimens group

ACTIVE COMPARATOR

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

Interventions

Etoposide DRUG

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

Also known as: VP-16

EAP regimen group

Cytarabine DRUG

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

Also known as: Ara-C

EAP regimen group

PEG-rhG-CSF DRUG

Day 6: 6mg

EAP regimen group

G-CSF DRUG

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.

EAP regimen group

CHOP COMBINATION_PRODUCT

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

Disease-specific chemotherapy mobilization regimens group

Hyper-CVAD COMBINATION_PRODUCT

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

Disease-specific chemotherapy mobilization regimens group

ID-MTX + Ara-C COMBINATION_PRODUCT

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

Disease-specific chemotherapy mobilization regimens group

DA-EPOCH COMBINATION_PRODUCT

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

Disease-specific chemotherapy mobilization regimens group

GDP COMBINATION_PRODUCT

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

Disease-specific chemotherapy mobilization regimens group

GDPE COMBINATION_PRODUCT

\[Gemcitabine + Cisplatin + Dexamethasone + Etoposide\] ± Rituximab

Disease-specific chemotherapy mobilization regimens group

ICE COMBINATION_PRODUCT

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

Disease-specific chemotherapy mobilization regimens group

DICE COMBINATION_PRODUCT

\[Dexamethasone + Ifosfamide + Ifosfamide + Etoposide\] ± Rituximab

Disease-specific chemotherapy mobilization regimens group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: collaborator
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: collaborator
• Jinhua People's Hospital: collaborator
• The Central Hospital of Lishui City: collaborator
• Shaoxing People's Hospital: collaborator
• Shaoxing Second Hospital: collaborator
• Zhejiang Provincial Tongde Hospital: collaborator
• Taizhou Hospital: collaborator
• Dongyang People's Hospital: collaborator
• Affiliated Hospital of Jiaxing University: collaborator
• Huzhou Central Hospital: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: collaborator
• Ningbo Medical Center Lihuili Hospital: collaborator
• Jinhua Municipal Central Hospital: collaborator
• The Affiliated People's Hospital of Ningbo University: lead
• First Affiliated Hospital of Wenzhou Medical University: collaborator

Study Sites (17)

Dongyang People's Hospital

Dongyang, Zhejiang, China

RECRUITING

The Affiliated Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

RECRUITING

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Tongde Hospital of Zhejiang Province

Hangzhou, Zhejiang, China

RECRUITING

Huzhou central hospital

Huzhou, Zhejiang, China

RECRUITING

The First Hospital of Jiaxing

Jiaxing, Zhejiang, China

RECRUITING

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, China

RECRUITING

Jinhua People's Hospital

Jinhua, Zhejiang, China

RECRUITING

Lishui Central Hospital

Lishui, Zhejiang, China

RECRUITING

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

RECRUITING

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China

RECRUITING

Shaoxing People's Hospital

Shaoxing, Zhejiang, China

RECRUITING

Shaoxing Second Hospital

Shaoxing, Zhejiang, China

RECRUITING

Taizhou Central Hospital

Taizhou, Zhejiang, China

RECRUITING

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

RECRUITING

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Etoposide; Cytarabine; pegylated granulocyte colony-stimulating factor; Granulocyte Colony-Stimulating Factor; CVAD protocol; EPOCH protocol; Guanosine Diphosphate; 1-(1-glycero)dodeca-1,3,5,7,9-pentaene; Ice

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Guanine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleotides; Ribonucleotides; Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Study Officials

• Peipei Ye

  The Affiliated People's Hospital of Ningbo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peipei Ye

CONTACT

86-13685832706; 39612903@qq.com

Ying Lu

CONTACT

86-13486090834; 814871416@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, two-arm, multicenter, exploratory study

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: July 25, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-10

Locations

CN (17)