drugset / Trial / NCT02532192
A Phase Ib Study of Belinostat With RDHAP Chemotherapy (Dexamethasone, Cytarabine, Cisplatinum) in Adults With Relapsed or Refractory Diffuse Large B-cell Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
The goal of this clinical research study is to find the highest tolerable dose of belinostat that can be combined with standard chemotherapy drugs (rituximab, cisplatin, cytarabine, and dexamethasone) in patients with relapsed or refractory DLBCL who are eligible for an autologous stem cell transplant (a transplant of the patient's own stem cells). The safety of the study drug will also be studied.
Timeline
- Start
- 2015-12
- Primary completion
- 2019-12
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belinostat | Small molecule | 200 mg/m2 | Intravenous |
| Background | Ciprofloxacin | Small molecule | 500 mg | Oral |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 2 g | Intravenous |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |
| Background | Fluconazole | Small molecule | 100 mg | Oral |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |