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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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).

Eligibility

Primary outcome measure(s)

• % 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.

Trial sites (17)

More The Affiliated People's Hospital of Ningbo University trials in China

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