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

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

Treatments tested in this trial

  • Glofitamab
  • Tocilizumab
  • Obinutuzumab
  • Gemcitabine
  • Oxaliplatin

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators