drugset / Trial / NCT02006485
Ublituximab in Combination With TGR-1202 +/- Ibrutinib or Bendamustine in Patients With B-cell Malignancies
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with TGR-1202, with or without ibrutinib or bendamustine, in patients with advanced hematologic malignancies
Timeline
- Start
- 2013-12-13
- Primary completion
- 2019-10
- Completion
- 2019-10
Publications
- Lunning M, Vose J, Nastoupil L, Fowler N, Burger JA, Wierda WG, Schreeder MT, Siddiqi T, Flowers CR, Cohen JB, Sportelli P, Miskin HP, Weiss MS, O'Brien S. Ublituximab and umbralisib in relapsed/refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. Blood. 2019 Nov 21;134(21):1811-1820. doi: 10.1182/blood.2019002118.
- Nastoupil LJ, Lunning MA, Vose JM, Schreeder MT, Siddiqi T, Flowers CR, Cohen JB, Burger JA, Wierda WG, O'Brien S, Sportelli P, Miskin HP, Purdom MA, Weiss MS, Fowler NH. Tolerability and activity of ublituximab, umbralisib, and ibrutinib in patients with chronic lymphocytic leukaemia and non-Hodgkin lymphoma: a phase 1 dose escalation and expansion trial. Lancet Haematol. 2019 Feb;6(2):e100-e109. doi: 10.1016/S2352-3026(18)30216-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | — | Intravenous |
| Subject | Ibrutinib | Small molecule | 420 mg | Oral |
| Subject | Ibrutinib | Small molecule | 560 mg | Oral |
| Subject | Ublituximab | Monoclonal antibody | 900 mg | Intravenous |
| Subject | Ublituximab + TGR-1202 | Unknown | 400 mg | Oral |
| Subject | Ublituximab + TGR-1202 | Unknown | 600 mg | Oral |
| Subject | Ublituximab + TGR-1202 | Unknown | 800 mg | Oral |
| Subject | Ublituximab + TGR-1202 | Unknown | 1200 mg | Oral |