NCT03225924

Study of Entospletinib (ENTO) in Newly Diagnosed DLBCL Patients With aaIPI>=1 Treated by Chemiotherapy

Phase Ib - II Study of Entospletinib (ENTO) in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL) Patients With aaIPI>=1 Treated by Rituximab, Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone (R-CHOP)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: The Lymphoma Academic Research Organisation · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• DLBCL

Interventions

Type	Name	Description
DRUG	Entospletinib	200mg or 400mg twice a day for 7 days every 21 cycles - total of 8 cycles
DRUG	Rituximab	cycles of 21 days - 375mg/m²
DRUG	Cyclophosphamide	cycles of 21 days - 750 mg/m²
DRUG	Doxorubicin	cycles of 21 days - 50mg/m²
DRUG	Vincristine	cycles of 21 days - 1.4mg/m²
DRUG	Prednisone	cycles of 21 days - 40mg/m²

Timeline

• Start date: 2017-07-26
• Primary completion: 2019-10-18
• Completion: 2019-10-18
• First posted: 2017-07-21
• Last updated: 2020-09-02

Locations

27 sites across 2 countries: Belgium, France