Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Obinutuzumab

Oxaliplatin

Antimetabolites

Antineoplastic Agents, Immunological

Participants will receive up to 8 cycles of Glofit-GemOx (glofitamab in combination with gemcitabine and oxaliplatin) administered in 21-day cycles, followed by up to 4 cycles of glofitamab monotherapy. A single dose of obinutuzumab will be administered 7 days prior to the first dose of glofitamab.

Participants will receive up to 8 cycles of Mosun-GemOx (mosunetuzumab in combination with gemcitabine and oxaliplatin) administered in 21-day cycles.

Participants will receive intravenous (IV) glofitamab in combination with gemcitabine and oxaliplatin for up to 8 cycles, followed by up to 4 cycles of glofitamab monotherapy.

Glofitamab

Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.

Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.

Participants will receive IV mosunetuzumab in combination with gemcitabine and oxaliplatin for up to 8 cycles.

Mosunetuzumab

Participants will receive a single dose of IV obinutuzumab 7 days prior to the first administration of glofitamab.

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

Tocilizumab

Clinical Trials

This study is designed to evaluate the safety and efficacy of glofitamab or mosunetuzumab in combination with gemcitabine and oxaliplatin (Glofit-GemOx or Mosun-GemOx) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL).

A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma

A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.

Severity of CRS was determined according to the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Criteria, in which Grade 1 as fever (≥38.0°C) with or without other symptoms; Grade 2 as fever with hypotension not requiring vasopressors and/or hypoxia requiring the use of oxygen (low-flow); and Grade 3 as fever with hypotension requiring one vasopressor with or without vasopressin and/or hypoxia requiring the use of oxygen (high-flow).

Per the 2014 Lugano Response Criteria for malignant lymphoma a CR = complete metabolic response with a score of 1, 2, or 3 on a 5-point scale (5PS), with higher scores indicating more extensive disease.

Per the 2014 Lugano Response Criteria for malignant lymphoma a CR = complete metabolic response with a score of 1, 2, or 3 on a 5-point scale (5PS), while a PR = partial metabolic response with a score of 4 or 5 on 5PS with higher scores indicating more extensive disease.

Hoffmann-La Roche

Participants received a single IV dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days)

Arm A: Glofit-GemOx

Participants received up to 8 cycles of mosunetuzumab + gemcitabine + oxaliplatin (cycle length = 21 days)

Arm B: Mosun-GemOx

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Medical Communications

Participants received a single intravenous (IV) dose of obinutuzumab 7 days prior to their first dose of glofitamab. Participants then received up to 8 cycles of glofitamab + gemcitabine + oxaliplatin, followed by up to 4 additional cycles of glofitamab monotherapy (cycle length = 21 days).

Number of Deaths Due to Adverse Events (AEs)

AEs leading to treatment discontinuation

AEs leading to dose modification or interruption

Tolerability of Study Treatment as Measured by Dose Interruptions, Dose Reductions, and Treatment Discontinuation Due to AEs

Complete Response (CR) Based on PET/CT as Determined by the Investigator According to the 2014 Lugano Response Criteria

Objective Response Rate (ORR), Defined as the Proportion of Participants With a Best Overall Response of Partial Response (PR) or CR, as Determined by the Investigator According to the 2014 Lugano Response Criteria

Pre-infusion Cycle 1 Day 8

Within 30 mins post infusion Cycle 1 Day 8

12 hours post infusion Cycle 1 Day 8

24 hours post infusion Cycle 1 Day 8

48 hours post infusion Cycle 1 Day 8

Pre-infusion Cycle 2 Day 1

Within 30 minutes post infusion Cycle 2 Day 1

6 hours post infusion Cycle 2 Day 1

20 hours post infusion Cycle 2 Day 1

44 hours post infusion Cycle 2 Day 1

The pharmacokinetic population consisted of all participants that received at least one dose of glofitamab or mosunetuzumab and who had data from at least one post-dose sample.

Spots Global Cancer Trial Database for A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial