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Evaluate Optimization of CRS Profile for Glofit Monotherapy and Glofit+GemOx in R/R Aggressive B-NHL

ConditionRelapsed or Refractory Aggressive B-Cell Non-Hodgkins Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) followed by glofitamab monotherapy treatment regimen (Cohort A), and for glofitamab monotherapy (Cohort B) in participants with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma. The study utilizes an optimized steroid premedication regimen and monitoring schedule specifically designed to enable the administration of the treatment regimen in an outpatient setting.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Life expectancy >= 12 weeks.

For participants in the Glofit-GemOx combination therapy cohort (Cohort A) and the glofitamab monotherapy cohort (Cohort B), participant with histologically confirmed diffuse large B-cell lymphoma, (de novo or transformed from a follicular lymphoma (FL); participants with transformed FL must be relapsed or refractory (R/R) to standard therapies of transformed FL) with one of the following diagnoses according to World Health Organization, fifth edition (Alaggio et al. 2022). A fresh biopsy at study entry is not mandated. The histology can be confirmed based on fresh biopsy, or pathology report from a previous biopsy or an assessment of archival tumor tissue.

Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified (NOS).

High-Grade B-Cell Lymphoma (HGBL), NOS.

Disqualifiers

Prior enrollment in Studies GO41943 (NCT04313608), GO41944 (STARGLO; NCT04408638), or Study GO44900 (NCT06624085).

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

Any history of Waldenstrom's macroglobulinemia.

Primary mediastinal B-cell lymphoma.

Trial design

Design model

Single group

Treatments tested in this trial

  • Obinutuzumab

    Drug

    Participants will receive intravenous (IV) obinutuzumab 7 days prior to the first dose of glofitamab.

  • Glofitamab

    Drug

    Participants will receive IV glofitamab, both in combination with gemcitabine and oxaliplatin and as monotherapy, for up to 12 cycles (cycle length = 21 days).

  • Gemcitabine

    Drug

    Participants will receive IV gemcitabine in combination with glofitamab and oxaliplatin for up to 8 cycles (cycles length = 21 days).

  • Oxaliplatin

    Drug

    Participants will receive IV oxaliplatin in combination with glofitamab and gemcitabine for up to 8 cycles (cycle length = 21 days).

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Cohort A: Glofit-GemOx Combination therapyExperimental treatment 4 interventions
Group B: Cohort B: Glofitamab MonotherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of Cytokine Release Syndrome (CRS)

Time frame
Up to approximately 5 years

Secondary outcomes

1

Incidence of Serious Cytokine Release Syndrome (CRS) Events

Time frame
Up to approximately 5 years
2

CRS Frequency Relative to the Start of Glofitamab Infusions

Time frame
Up to approximately 5 years
3

Incidence and Severity of Adverse Events (AEs)

Time frame
Up to approximately 5 years
4

Complete Response (CR) Rate as Determined by Independent Review Facility (IRF) and the Investigator

CR rate is defined as the proportion of participants whose best overall response is a CR based on PET/CT according to the 2014 Lugano Response Criteria during the study, as determined by the Independent Review Facility and the investigator.

Time frame
Up to approximately 5 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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