Authorised Therapeutic confirmatory (Phase III) Relapsed or refractory diffuse large B-cell lymphoma

A Study to Evaluate the Efficacy and Safety of Glofitamab in Combination with Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination with Gemcitabine Plus Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma

EU CTIS ID: 2023-506899-27-00

What this study is testing

To evaluate the efficacy of glofitamab (Glofit)- gemcitabine plus oxaliplatin (GemOx) compared with rituximab in combination with gemcitabine and oxaliplatin (R-GemOx) on the basis of overall survival

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Life expectancy >= 12 weeks
  • Histologically confirmed diffuse large B-cell lymphoma, not otherwise specified (NOS)
  • Relapsed/refractory disease
  • At least one (≥ 1) line of prior systemic therapy
  • Patients who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant
  • At least one bi-dimensionally measurable (>= 1.5 cm) nodal lesion, or one bi-dimensionally measurable (=> 1 cm) extranodal lesion, as measured on computed tomography (CT) scan

You likely can't join if

  • Patient has failed only one prior line of therapy and is a candidate for stem cell transplantation
  • Contraindication to Obinutuzumab, rituximab, gemcitabine or oxaliplatin, or tocilizumab
  • History of transformation of indolent disease to diffuse large B-cell lymphoma (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
  • Primary mediastinal B-cell lymphoma
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products

The study team makes the final eligibility decision.

Where it's taking place

  • United States
  • United Kingdom
  • China
  • Japan
  • Taiwan
  • Korea, Republic of
  • Switzerland
  • Australia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; United Kingdom; China; Japan; Taiwan; Korea, Republic of and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.