NCT05861050 · City of Hope Medical Center
Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Biopsy
Undergo tumor biopsy
PROCEDURE
Biospecimen Collection
Undergo collection of blood samples
PROCEDURE
Bone Marrow Biopsy
Undergo bone marrow biopsy
PROCEDURE
Computed Tomography
Undergo CT scan
BIOLOGICAL
Glofitamab
Given IV
DRUG
Lenalidomide
Given PO
BIOLOGICAL
Obinutuzumab
Given IV
PROCEDURE
Positron Emission Tomography
Undergo PET scan
DRUG
Venetoclax
Given PO
Primary outcome measures
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
Incidence of dose limiting toxicity
Time frame: Up to 63 days after initiation of venetoclax
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Documented informed consent of the participant and/or legally authorized representative
- Assent, when appropriate, will be obtained per institutional guidelines
- Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- If unavailable, exceptions may be granted with study principal investigator (PI) approval
- Age: \>= 18 to 80 years
- Eastern Cooperative Oncology Group =\< 2
- Diagnosis of MCL established by histologic assessment including one of the following:
- Immunohistochemistry of the biopsy
- Flow cytometry of the biopsy
- Evidence of t(11;14) translocation involving the cyclin D1 gene by fluorescence in situ hybridization (FISH), and/or cyclin D1 expression by immunohistochemistry (IHC) unless disease is morphologically consistent with MCL and has IHC expression of SOX11
- Requiring treatment for MCL, and for which no prior systemic anticancer therapies have been received
- Local radiotherapy not exceeding a total dos
Where
- Duarte, California
- Salt Lake City, Utah
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 19, 2026 · Source of record for eligibility and locations