A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma

Part of paid clinical trials in Orange, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT05364424
Phase
PHASE1
Status
Completed

Conditions

  • Diffuse Large B-Cell Lymphoma (DLBCL)

Eligibility Criteria

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

Interventions

  • Glofitamab — DRUG
    Participants will receive intravenous (IV) glofitamab for up to 3 cycles.
  • Obinutuzumab — DRUG
    Participants will receive IV obinutuzumab on Cycle 1 Day 1.
  • Tocilizumab — DRUG
    Participants will receive IV tocilizumab as necessary to manage cytokine release syndrome (CRS) events.
  • Rituximab — DRUG
    Participants will receive up to 2 doses of IV rituximab.
  • Ifosfamide — DRUG
    Participants will receive IV ifosfamide for up to 3 cycles.
  • Carboplatin — DRUG
    Participants will receive IV carboplatin for up to 3 cycles.
  • Etoposide — DRUG
    Participants will receive IV etoposide for up to 3 cycles.

Study Details

The purpose of this study is to evaluate the preliminary efficacy, safety, and pharmacokinetics of glofitamab (glofit) in combination with rituximab plus ifosfamide, carboplatin, and etoposide (R-ICE) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have failed one prior line of therapy incorporating an anti-cluster of differentiation (CD) 20 antibody (i.e., rituximab) and an anthracycline, and who are transplant or chimeric antigen receptor T-cell (CAR-T) therapy eligible, defined as being medically eligible for intensive platinum-based salvage therapy followed by autologous stem cell transplantation (ASCT) or for CAR-T therapy.

Key Dates

Start date
Nov 4, 2022
Status verified
Nov 2025
Primary completion
Oct 15, 2025
Completion
Oct 15, 2025

Study Design

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

Arms

  • Experimental: R/R DLBCL
    Participants will receive up to 3 21-day cycles of glofitamab, rituximab, ifosfamide, carboplatin, and etoposide (glofit-R-ICE).

Primary Outcome Measure

Objective response rate (ORR), defined as the proportion of participants that achieves a CR or PR within three cycles of glofit-R-ICE, as determined by the investigator according to Lugano criteria [ Time Frame: Up to 2.5 years ]

Locations (9)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center UCIOrangeCalifornia92868-
Memorial Cancer Institute at Memorial WestPembroke PinesFlorida33028-
The University of ChicagoChicagoIllinois60637-
Tulane Medical CenterNew OrleansLouisiana70112-
UMASS Memorial Medical CenterWorcesterMassachusetts01655-
New York University Langone Medical CenterNew YorkNew York10016-
Cleveland Clinic FoundationClevelandOhio44195-
MD Anderson Cancer CenterHoustonTexas77030-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Orange, CA

By research site
Chao Family Comprehensive Cancer Center UCI· Orange, CAMemorial Cancer Institute at Memorial West· Pembroke Pines, FLThe University of Chicago· Chicago, ILTulane Medical Center· New Orleans, LAUMASS Memorial Medical Center· Worcester, MANew York University Langone Medical Center· New York, NY

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