drugset / Trial / NCT05466318
ChiCGB vs BEAM in High-risk or R/R Lymphomas
RandomizedParallel-groupOpen-labelTreatment
Summary
High-dose chemotherapy (HDT) with autologous stem cell transplantation (ASCT) plays a vital role in treating high-risked or relapsed/refractory lymphoma. Our previous study showed chidamide combined with cladribine, gemcitabine, and busulfan (ChiCGB) as conditioning therapy improved the survival of these patients. So we designed this trial to verify if ChiCGB were better than BCNU, etoposide, cytarabine, and melphalan (BEAM). Patients with diffuse large B cell or extra-nodal NK/T cell Lymphoma who consent to this study will be randomized into the trial group who receive ChiCGB or the control group whom receive BEAM. Patients will be followed for up to 2 years after the hematopoietic cell transplantation (HCT).
Timeline
- Start
- 2022-07-01
- Primary completion
- 2025-12-30
- Completion
- 2025-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 3.2 mg/kg | Intravenous |
| Subject | Cladribine | Small molecule | 6 mg/m2 | Intravenous |
| Comparator | Cytarabine | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | Etoposide | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 2500 mg/m2 | Intravenous |
| Comparator | Melphalan | Small molecule | 140 mg/m2 | Intravenous |
| Subject | Tucidinostat | Small molecule | 30 mg | Oral |
| Comparator | carmustine | Small molecule | 300 mg/m2 | Intravenous |