A Study to Evaluate Safety, Pharmacokinetics, and Clinical Activity of Combination of RO6870810 and Venetoclax, With or Without Rituximab, in Participants With Relapsed/Refractory DLBCL and/or High-Grade B-Cell Lymphoma and/or High Grade B-Cell Lymphoma With MYC and/or BCL2 and/or BCL6

PHASE1CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

August 28, 2017

Primary Completion Date

July 3, 2019

Study Completion Date

July 3, 2019

Conditions
Diffuse Large B-cell LymphomaHigh-Grade B-cell Lymphoma
Interventions
DRUG

RO6870810

RO6870810 subcutaneously (SC) at dose of 0.30, 0.45, or 0.65 milligram per kilogram (mg/kg) on Days 1-14 of 21-day cycles.

DRUG

Venetoclax

Venetoclax tablets orally at dose of 400 mg once daily (QD) continuously for 21 days.

DRUG

Rituximab

Rituximab intravenously (IV) at dose of 375 mg/m\^2 weekly during the first 21-day cycle (C1) and on day 1 of each cycle thereafter.

Trial Locations (9)

2100

Rigshospitalet; Hæmatologisk Klinik, København Ø

3000

Peter MacCallum Cancer Centre-East Melbourne, Melbourne

10065

Weill Cornell Medical College, New York

28040

START Madrid-FJD, Hospital Fundacion Jimenez Diaz, Madrid

28203

Levine Cancer Institute - Blythe, Charlotte

91010

City of Hope National Medical Center, Duarte

94305-5820

Stanford Cancer Center, Stanford

08025

Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia, Barcelona

08907

Hospital Duran i Reynals; Servicio de Hematologia, Barcelona

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03255096 - A Study to Evaluate Safety, Pharmacokinetics, and Clinical Activity of Combination of RO6870810 and Venetoclax, With or Without Rituximab, in Participants With Relapsed/Refractory DLBCL and/or High-Grade B-Cell Lymphoma and/or High Grade B-Cell Lymphoma With MYC and/or BCL2 and/or BCL6 | Biotech Hunter | Biotech Hunter