A Study to Evaluate Glofitamab as Single Agent Administered After Pretreatment With Obinutuzumab in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Sponsor
Hoffmann-La Roche
Study ID
NCT04657302
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Obinutuzumab — DRUG
    Participants will receive 1000 mg of intravenous (IV) obinutuzumab on Cycle 1 Day 1.
  • Glofitamab — DRUG
    Participants will receive 2.5 mg of IV glofitamab Cycle 1 Day 8, 10 mg at Cycle 1 Day 15, and 30 mg on Day 1 of Cycles 2-12 Q3W (cycle length = 21 days).
  • Tocilizumab — DRUG
    Participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS).

Study Details

This study will evaluate the pharmacokinetics, safety, tolerability, and efficacy of glofitamab as a single agent following a fixed single dose of obinutuzumab in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy.

Key Dates

Start date
Jan 8, 2021
Status verified
Jan 2024
Primary completion
Oct 25, 2022
Completion
Jan 12, 2024

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: R/R DLBCL
    Participants will receive a fixed dose of obinutuzumab pre-treatment followed by glofitamab on Cycle 1 Days 8 and 15, then every 3 weeks (Q3W) from Cycles 2-12 (cycle length = 21 days).

Primary Outcome Measure

Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 3.5 years ]

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