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Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma

StatusSuspended
PhasePhase 1/2
Started2023-08-10
View on ClinicalTrials.gov ↗

Amendment history

2026-09-23
Recruitment suspended: Safety Issues
2026-07-20
Study Status, Contacts/Locations v7
Study sites2→3
2026-02-17
Study Status v6
Primary completion date2026-02-01→2027-02-01
Completion date2026-02-01→2027-02-01
2025-08-27
Study Status, Contacts/Locations v5
Study sites1→2
2025-03-17
2 amendments v3-v4
2 re-verifications since 2024-11-05, no change to tracked fields
Show 2 earlier versions
2023-10-30
Study Status v2
Primary completion date2025-05-23→2026-02-01
Completion date2025-05-23→2026-02-01
Start dateestimated 2023-09-23→confirmed 2023-08-10
2023-08-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2023-05-15
Original filing
This phase I/II trial tests the safety and effectiveness of glofitamab (with obinutuzumab pretreatment), venetoclax, and lenalidomide in treating patients with newly diagnosed, high risk mantle cell lymphoma. Glofitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Lenalidomide works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Giving venetoclax, glofitamab with obinutuzumab, and lenalidomide together may kill more cancer cells in patients with newly diagnosed, high risk mantle cell lymphoma.
Trial Details
NCT Number NCT05861050
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Blastoid Variant Mantle Cell Lymphoma, Mantle Cell Lymphoma, Pleomorphic Variant Mantle Cell Lymphoma
Enrollment 50 participants
Start Date 2023-08-10
Primary Completion 2027-02-01 (estimated)
Study Completion 2027-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-22