drugset / Trial / NCT03225924
Study of Entospletinib (ENTO) in Newly Diagnosed DLBCL Patients With aaIPI>=1 Treated by Chemiotherapy
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of the phase Ib of the study is to determine the recommended phase 2 dose (RP2D) for entospletinib (ENTO) in patients treated with R-CHOP. The primary objective of the phase II is to determine the complete metabolic response (CMR) rate by the Lugano classification 2014 (Deauville scale 1-3) at the end of treatment.
Timeline
- Start
- 2017-07-26
- Primary completion
- 2019-10-18
- Completion
- 2019-10-18
Outcome
Outcome not reported
Stopped: “Stop of drug development”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Entospletinib | Small molecule | 200 mg | — |
| Subject | Entospletinib | Small molecule | 400 mg | — |
| Background | Cyclophosphamide | Other / unclassified | 750 mg/m2 | — |
| Background | Doxorubicin | Other / unclassified | 50 mg/m2 | — |
| Background | Prednisone | Other / unclassified | 40 mg/m2 | — |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Background | Vincristine | Small molecule | 1.4 mg/m2 | — |