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

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.

• Etoposide (Drug), also known as VP-16: Day 1\~Day 2: 75mg/m\^2
• Cytarabine (Drug), also known as Ara-C: Day 1\~Day 2: 200g/m\^2, q12h
• PEG-rhG-CSF (Drug): Day 6: 6mg
• 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.
• CHOP (Combination product): \[Cyclophosphamide (Cy) + Doxorubicin (ADM) + Vincristine (VDS) + Prednisone (Pred) \]± Rituximab (R)
• Hyper-CVAD (Combination product): \[Cyclophosphamide + Doxorubicin + Vincristine + Dexamethasone (DXM)\] ± Rituximab
• ID-MTX + Ara-C (Combination product): \[High-Dose Methotrexate (MTX) + Cytarabine\] ± Rituximab
• DA-EPOCH (Combination product): \[Etoposide + Doxorubicin + Vincristine + Cyclophosphamide + Prednisone\] ± Rituximab
• GDP (Combination product): \[Gemcitabine (G) + Cisplatin (P) + Dexamethasone (DXM)\] ± Rituximab
• GDPE (Combination product): \[Gemcitabine + Cisplatin + Dexamethasone + Etoposide\] ± Rituximab
• ICE (Combination product): \[Etoposide + Ifosfamide (IFO) + Carboplatin\] ± Rituximab
• DICE (Combination product): \[Dexamethasone + Ifosfamide + Ifosfamide + Etoposide\] ± Rituximab
• G-CSF (Drug): From Day 6, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.

Primary outcomes

• % of patients achieving the collection of ≥5×10^6 CD34+ cells/kg [1 month]: Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10\^6/kg) after a single collection.

Secondary outcomes

• % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg [1 month]: 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.
• CD34+ cells and the average number of collections [1 month]: 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.
• Adverse Rvents (AEs) [1 month]: To observe and compare the hematological and non-hematological adverse reactions between the EAP regimen and the disease-specific chemotherapy regimen.
• % of patients who use Plerixafor [1 month]: To observe and compare the proportion of patients who receive plerixafor added to the EAP regimen and the disease-specific chemotherapy regimen.

Sex: All, ages: 18 Years to 75 Years

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.

• Peipei Ye, Principal investigator, The Affiliated People's Hospital of Ningbo University