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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05861050
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Blastoid Variant Mantle Cell Lymphoma
  • Mantle Cell Lymphoma
  • Pleomorphic Variant Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Glofitamab — BIOLOGICAL
    Given IV
  • Lenalidomide — DRUG
    Given PO
  • Obinutuzumab — BIOLOGICAL
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan
  • Venetoclax — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Aug 10, 2023
Status verified
Feb 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (venetoclax, glofitamab, lenalidomide)
    Patients receive venetoclax PO, obinutuzumab IV, glofitamab IV, and lenalidomide IV on study. Patients undergo bone marrow biopsy, blood sample collection, and CT scan and/or PET scan throughout the study. Patients may undergo tumor biopsy throughout the study.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: From first dose of combination lenalidomide, venetoclax, and glofitamab to the occurrence of definitive disease progression or death from any cause, assessed up to 24 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Tycel J. Phillips
[email protected]
626-218-2405
Tycel J. Phillips (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer InstituteSalt Lake CityUtah84112
Daniel Ermann, MD
[email protected]
801-587-7000

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CAHuntsman Cancer Institute· Salt Lake City, UT

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