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A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma

ConditionLymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Life expectancy at least 12 weeks

Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry

Relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen) disease

At least 1 line of prior systemic therapy including a BTK inhibitor and additional systemic therapy option

Disqualifiers

Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of tocilizumab, 2 months after the final dose of glofitamab, whichever is longer

Leukemic, non-nodal MCL

History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products

Contraindication to obinutuzumab or rituximab, and either bendamustine or lenalidomide

Trial design

Design model

Parallel

Treatments tested in this trial

  • Obinutuzumab

    Drug

    Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from Cycle 1 Day 1

  • Glofitamab

    Drug

    Participants will receive IV glofitamab beginning Cycle 1 Day 8 for 12 cycles (cycle length = 21 days).

  • Rituximab

    Drug

    Participants will receive IV rituximab every 28 days for up to 6 cycles (when in combination with bendamustine), or until disease progression (when in combination with lenalidomide).

  • Bendamustine

    Drug

    Participants will receive IV bendamustine on Days 1 and 2 Q4W for 6 cycles (cycle length = 28 days).

  • Lenalidomide

    Drug

    Participants will receive oral lenalidomide once daily on Days 1-21 Q4W until disease progression.

  • Tocilizumab

    Drug

    Participants will receive IV tocilizumab as required to manage cytokine release syndrome (CRS) events.

Treatment groups

182 Participants
are divided into 2 treatment groups
Group A: Glofitamab monotherapyExperimental treatment 3 interventions
Group B: BR or R-LenActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

Time frame
From randomization to the first occurrence of disease progression or death from any cause (up to approximately 24 months)

Secondary outcomes

1

Complete response (CR) rate

Time frame
Up to approximately 24 months
2

Objective response rate (ORR)

Time frame
Up to approximately 24 months
3

Overall survival (OS)

Time frame
From randomization to death from any cause (up to approximately 24 months)
4

Time to deterioration in physical functioning/fatigue

Time frame
From randomization to a 10-point decrease in physical functioning/10-point increase in fatigue compared to baseline (up to approximately 24 months)

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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