Non-Hodgkin's Lymphoma, Hematopoietic Stem Cell Mobilization
Conditions
Keywords
Non-Hodgkin's Lymphoma, Disease-Specific Chemotherapy, Hematopoietic stem cell mobilization, Etoposide, Cytarabine Combined with PEG-rhG-CSF
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).
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.
Interventions
DRUGEtoposide
Day 1\ Day 2: 75mg/m\^2
DRUGCytarabine
Day 1\ Day 2: 200g/m\^2, q12h
DRUGPEG-rhG-CSF
Day 6: 6mg
DRUGG-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.
COMBINATION_PRODUCTCHOP
\[Cyclophosphamide (Cy) + Doxorubicin (ADM) + Vincristine (VDS) + Prednisone (Pred) \]± Rituximab (R)
COMBINATION_PRODUCTHyper-CVAD
\[Cyclophosphamide + Doxorubicin + Vincristine + Dexamethasone (DXM)\] ± Rituximab
COMBINATION_PRODUCTID-MTX + Ara-C
\[High-Dose Methotrexate (MTX) + Cytarabine\] ± Rituximab
COMBINATION_PRODUCTDA-EPOCH
\[Etoposide + Doxorubicin + Vincristine + Cyclophosphamide + Prednisone\] ± Rituximab
COMBINATION_PRODUCTGDP
\[Gemcitabine (G) + Cisplatin (P) + Dexamethasone (DXM)\] ± Rituximab
COMBINATION_PRODUCTGDPE
\[Gemcitabine + Cisplatin + Dexamethasone + Etoposide\] ± Rituximab
COMBINATION_PRODUCTICE
\[Etoposide + Ifosfamide (IFO) + Carboplatin\] ± Rituximab
COMBINATION_PRODUCTDICE
\[Dexamethasone + Ifosfamide + Ifosfamide + Etoposide\] ± Rituximab
Sponsors
First Affiliated Hospital of Zhejiang University
First Affiliated Hospital of Wenzhou Medical University
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Jinhua People's Hospital
The Central Hospital of Lishui City
Shaoxing People's Hospital
Shaoxing Second Hospital
Zhejiang Provincial Tongde Hospital
Taizhou Hospital
Dongyang People's Hospital
Affiliated Hospital of Jiaxing University
Huzhou Central Hospital
Second Affiliated Hospital of Wenzhou Medical University
Ningbo Medical Center Lihuili Hospital
Jinhua Municipal Central Hospital
The Affiliated People's Hospital of Ningbo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, randomized, two-arm, multicenter, exploratory study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % 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
| Measure | Time frame | Description |
|---|---|---|
| % 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. |
Countries
China
Contacts
Primary ContactPeipei Ye
Backup ContactYing Lu
Outcome results
None listed