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A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

ConditionLymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the United States, including under-represented racial and ethnic populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed DLBCL, not otherwise specified (NOS)

Relapsed (disease that has recurred following a response that lasted ≥ 6 months after completion of the last line of therapy) or refractory ( disease that did not respond to or that progressed < 6 months after completion of the last line of therapy) disease

At least one prior line of systemic therapy

Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)

Disqualifiers

Prior enrollment in Study GO41944 (STARGLO; NCT04408638)

Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation

History of transformation of indolent disease to DLBCL

High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines

Trial design

Design model

Single group

Treatments tested in this trial

  • Glofitamab

    Drug

    Participants will receive IV glofitamab for up to 12 cycles (cycle length = 21 days)

  • Tocilizumab

    Drug

    Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)

  • Obinutuzumab

    Drug

    Participants will receive IV obinutuzumab pretreatment

  • Gemcitabine

    Drug

    Participants will receive IV gemcitabine for up to 8 cycles (cycle length = 21 days)

  • Oxaliplatin

    Drug

    Participants will receive IV oxaliplatin for up to 8 cycles (cycle length = 21 days)

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Gemcitabine + Glofitamab + OxaliplatinExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Incidence of Adverse Events (AEs)

Time frame
Up to 3 years
2

Complete response (CR) rate

Time frame
Up to 3 years

Secondary outcomes

1

Objective response rate (ORR)

Time frame
Up to 3 years
2

Duration of response (DOR)

Time frame
From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 3 years)
3

Duration of CR

Time frame
From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (up to 3 years)
4

Progression-free survival (PFS)

Time frame
From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 3 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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