drugset / Trial / NCT06520163
Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma
Phase 3
Recruiting
99 enrolled
The Affiliated People's Hospital of Ningbo University
Affiliated Hospital of Jiaxing University · collabDongyang People's Hospital · collabFirst Affiliated Hospital of Wenzhou Medical University · collabFirst Affiliated Hospital of Zhejiang University · collabHuzhou Central Hospital · collabJinhua Municipal Central Hospital · collabJinhua People's Hospital · collabNingbo Medical Center Lihuili Hospital · collabSecond Affiliated Hospital of Wenzhou Medical University · collabShaoxing People's Hospital · collabShaoxing Second Hospital · collabTaizhou Hospital · collabTaizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University · collabThe Central Hospital of Lishui City · collabZhejiang Provincial Tongde Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2024-08-01
- Primary completion
- 2026-08
- Completion
- 2026-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | — |
| Subject | Cisplatin | Other / unclassified | — | — |
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Cytarabine | Small molecule | 200 g | — |
| Subject | Dexamethasone | Small molecule | — | — |
| Subject | Doxorubicin | Other / unclassified | — | — |
| Subject | Etoposide | Small molecule | 75 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Ifosfamide | Small molecule | — | — |
| Subject | Methotrexate | Small molecule | — | — |
| Subject | Pegfilgrastim | Protein / enzyme biologic | 6 mg | — |
| Subject | Prednisone | Other / unclassified | — | — |
| Subject | Rituximab | Monoclonal antibody | — | — |
| Subject | Vincristine | Small molecule | — | — |
| Comparator | G-CSF | Unknown | 5 ug/kg | Subcutaneous |