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

Part of paid clinical trials in Berkeley, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT06084936
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Oct 22, 2023
Status verified
Jun 2026
Primary completion
Aug 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
182 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Glofitamab monotherapy
    Participants will receive two intravenous (IV) obinutuzumab pretreatments prior to receiving IV glofitamab for 12 cycles (cycle length = 21 days).
  • Active Comparator: BR or R-Len
    Participants will receive bendamustine + rituximab for up to 6 cycles (cycle length = 28 days), or rituximab + lenalidomide (cycle length = 28 days) until disease progression.

Primary Outcome Measure

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) ]

Central Contacts

  • Reference Study ID Number: GO43878 https://forpatients.roche.com/
    888-662-6728
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (18)

FacilityCityStateZIPSite coordinators
Alta Bates Summit Medical CenterBerkeleyCalifornia94704-
City of Hope Cancer CenterDuarteCalifornia91010-
University of California Los Angeles (UCLA) - Cancer Care - Santa MonicaSanta MonicaCalifornia90404-2023-
Yale Cancer CenterNew HavenConnecticut06520-
Georgetown UniversityWashington D.C.District of Columbia20007-
University of MiamiCoral GablesFlorida33146-
Indiana UniversityIndianapolisIndiana46202-
University of Michigan Health SystemAnn ArborMichigan48109-
St. Luke's HospitalChesterfieldMissouri63017-
Renown Regional Medical CenterRenoNevada89502-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
University of RochesterRochesterNew York14642-
Medical University of S. CarolinaCharlestonSouth Carolina29425-
Avera Cancer InstituteSioux FallsSouth Dakota57105-
Renovatio Clinical - El PasoEl PasoTexas79915-
Renovatio ClinicalThe WoodlandsTexas77380-
University of VirginiaCharlottesvilleVirginia22906-
West Virginia UniversityMorgantownWest Virginia26506-

Find similar trials in Berkeley, CA

By research site
Alta Bates Summit Medical Center· Berkeley, CACity of Hope Cancer Center· Duarte, CAUniversity of California Los Angeles (UCLA) - Cancer Care - Santa Monica· Santa Monica, CAYale Cancer Center· New Haven, CTGeorgetown University· Washington D.C., DCUniversity of Miami· Coral Gables, FL

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