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OncoMatch/Clinical Trials/NCT06084936

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

Is NCT06084936 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for lymphoma.

Phase 3RecruitingHoffmann-La RocheNCT06084936Data as of May 2026

Treatment: Obinutuzumab · Glofitamab · Rituximab · Bendamustine · Lenalidomide · TocilizumabThe 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).

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Required: CCND1 overexpression

Required: CCND1 t(11:14)

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: BTK inhibitor

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

Cannot have received: bispecific antibody targeting both CD20 and CD3 (glofitamab)

Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3

Cannot have received: CAR-T cell therapy

Prior treatment with CAR-T cell therapy

Cannot have received: systemic therapy or BTK inhibitors or any investigational agent for the purposes of treating cancer

Exception: within 2 weeks or 5 half-lives (whichever is shorter) prior to first study treatment

Treatment with systemic therapy or BTK inhibitors, or any investigational agent for the purposes of treating cancer within 2 weeks or 5 half-lives (whichever is shorter) prior to first study treatment

Cannot have received: systemic immunosuppressive medications

Exception: within 2 weeks or five half-lives (whichever is shorter) prior to the first dose of study treatment

Prior treatment with systemic immunosuppressive medications within 2 weeks or five half-lives (whichever is shorter) prior to the first dose of study treatment

Cannot have received: corticosteroid therapy

Exception: within 2 weeks prior to first dose of study treatment

Corticosteroid therapy within 2 weeks prior to first dose of study treatment

Cannot have received: live, attenuated vaccine

Exception: within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study

Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study

Cannot have received: solid organ transplantation or allogenic stem cell transplant

Prior solid organ transplantation or allogenic stem cell transplant

Lab requirements

Blood counts

adequate hematological function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Alta Bates Summit Medical Center · Berkeley, California
  • City of Hope Cancer Center · Duarte, California
  • University of California Los Angeles (UCLA) - Cancer Care - Santa Monica · Santa Monica, California
  • Yale Cancer Center · New Haven, Connecticut
  • Georgetown University · Washington D.C., District of Columbia

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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