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

Part of paid clinical trials in Duarte, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT03255096
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RO6870810 — DRUG
    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.
  • Venetoclax — DRUG
    Venetoclax tablets orally at dose of 400 mg once daily (QD) continuously for 21 days.
  • Rituximab — DRUG
    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.

Study Details

The purpose of this study is to evaluate the safety, tolerability and clinical activity of RO6870810 in combination with venetoclax and when co-administered with rituximab in participants with relapse/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and/or high-grade B-cell lymphoma with myelocytomatosis oncogene (MYC) and/or B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) gene rearrangements (HGBL-DH/TH).

Key Dates

Start date
Aug 28, 2017
Status verified
Jan 2022
Primary completion
Jul 3, 2019
Completion
Jul 3, 2019

Study Design

Enrollment
39 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Phase (Part 1)
    Participants will receive either RO6870810 and venetoclax or RO6870810 and venetoclax along with rituximab until disease progression, unacceptable toxicities or withdrawal from treatment for other reasons, or death.
  • Experimental: Expansion Phase (Part 2)
    Participants will receive RO6870810 and venetoclax along with rituximab (or RO6870810 and venetoclax, if the combination of the 3 drugs is not tolerable) at a recommended dose established in dose escalation phase until disease progression, unacceptable toxicities or withdrawal from treatment for other reasons, or death.

Primary Outcome Measure

Percentage of Participants With Dose-Limiting Toxiciities (DLT)- Part 1 [ Time Frame: Cycle (C) 1 (21 days) ]

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
Stanford Cancer CenterStanfordCalifornia94305-5820-
Weill Cornell Medical CollegeNew YorkNew York10065-
Levine Cancer Institute - BlytheCharlotteNorth Carolina28203-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAStanford Cancer Center· Stanford, CAWeill Cornell Medical College· New York, NYLevine Cancer Institute - Blythe· Charlotte, NC

Related Studies