drugset / Trial / NCT03892421
Outpatient Administration of R-DHAP in Relapsed/Refractory Non-Hodgkin Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
The goal of this study is to evaluate the efficacy and safety of a combination of the anti-CD20 monoclonal antibody Rituximab, Dexamethasone, daily high dose Cytarabine twice, and Carboplatin; delivered in an outpatient setting.
Timeline
- Start
- 2018-04-05
- Primary completion
- 2021-01-30
- Completion
- 2021-04-30
Publications
- Background Velasquez WS, Cabanillas F, Salvador P, McLaughlin P, Fridrik M, Tucker S, Jagannath S, Hagemeister FB, Redman JR, Swan F, et al. Effective salvage therapy for lymphoma with cisplatin in combination with high-dose Ara-C and dexamethasone (DHAP). Blood. 1988 Jan;71(1):117-22.
- Background Momparler RL. Optimization of cytarabine (ARA-C) therapy for acute myeloid leukemia. Exp Hematol Oncol. 2013 Aug 6;2:20. doi: 10.1186/2162-3619-2-20. eCollection 2013.
- Background Yanik G, Yousuf N, Miller MA, Swerdlow SH, Lampkin B, Raza A. In vivo determination of cell cycle kinetics of non-Hodgkin's lymphomas using iododeoxyuridine and bromodeoxyuridine. J Histochem Cytochem. 1992 May;40(5):723-8. doi: 10.1177/40.5.1573252.
- Background Sandlund JT, Santana VM, Hudson MM, Onciu M, Head D, Murry DJ, Ribeiro R, Wallace D, Rencher R, Pui CH. Combination of dexamethasone, high-dose cytarabine, and carboplatin is effective for advanced large-cell non-Hodgkin lymphoma of childhood. Cancer. 2008 Aug 15;113(4):782-90. doi: 10.1002/cncr.23630.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Cytarabine 2000 mg/m² qd 2 days | Unknown | 2000 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 40 mg | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | 300 ug | Subcutaneous |