drugset / Trial / NCT02840539
Trial of Bortezomib, Cytarabine, and Dexamethasone in Mantle Cell Lymphoma
Phase 2
Completed
19 enrolled
Seoul National University Hospital
Consortium for Improving Survival of Lymphoma · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether bortezomib, cytarabine, and dexamethasone are effective in the treatment of relapsed or refractory mantle cell lymphoma after 1 to 3 lines of previous treatment.
Timeline
- Start
- 2016-10-11
- Primary completion
- 2021-03-31
- Completion
- 2022-12-31
Publications
- Background Robak T, Huang H, Jin J, Zhu J, Liu T, Samoilova O, Pylypenko H, Verhoef G, Siritanaratkul N, Osmanov E, Alexeeva J, Pereira J, Drach J, Mayer J, Hong X, Okamoto R, Pei L, Rooney B, van de Velde H, Cavalli F; LYM-3002 Investigators. Bortezomib-based therapy for newly diagnosed mantle-cell lymphoma. N Engl J Med. 2015 Mar 5;372(10):944-53. doi: 10.1056/NEJMoa1412096.
- Shin J, Lee JY, Lee GW, Kim WS, Park Y, Do YR, Kim DS, Kim KH, Choi YS, Byun JM, Hong J, Kim I, Yoon SS, Koh Y. Phase II study of bortezomib, cytarabine and dexamethasone in relapsed or refractory mantle cell lymphoma. Br J Haematol. 2023 Sep;202(6):e54-e57. doi: 10.1111/bjh.18965. Epub 2023 Jul 5. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Subcutaneous |
| Subject | Cytarabine | Small molecule | 1.5 g | Intravenous |
| Subject | Dexamethasone | Small molecule | 20 mg | Intravenous |
| Subject | Pegteograstim | Protein / enzyme biologic | 6 mg | Subcutaneous |