Actively Recruiting
Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma
Led by City of Hope Medical Center · Updated on 2026-02-19
50
Participants Needed
2
Research Sites
181 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent and assent when appropriate
- Agreed to use archival tumor tissue or obtained approval for exceptions
- Age between 18 and 80 years
- Eastern Cooperative Oncology Group score of 2 or less
- Confirmed diagnosis of mantle cell lymphoma by biopsy with immunohistochemistry or flow cytometry
- Evidence of t(11;14) translocation or cyclin D1 expression, or SOX11 expression consistent with MCL
- Require treatment for MCL with no prior systemic anticancer therapy (local radiotherapy under 20 Gy allowed if >2 weeks before treatment)
- Laboratory or clinical findings attributable to MCL, including asymptomatic blastoid or pleomorphic variants
- Presence of high risk features such as blastoid/pleomorphic variants, Ki67 ≥ 50%, TP53 mutation, del(17p), complex karyotype, high-risk MIPI score (≥6.2), bulky disease, or other specified gene mutations
- Ability to swallow oral capsules or tablets
- Adequate blood counts depending on bone marrow involvement
- Liver function tests within specified limits
- Creatinine clearance ≥ 60 mL/min
- Normal coagulation parameters or therapeutic levels if on anticoagulants
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception or abstain during and after treatment per protocol
- Registered and compliant with the Revlimid REMS program
You will not qualify if you...
- Treatment with warfarin
- Use of strong/moderate CYP3A inhibitors or inducers within 4 weeks prior to study or consumption of grapefruit products within 3 days before venetoclax
- Ongoing corticosteroid use >30 mg/day prednisone or equivalent; stable use ≤30 mg/day allowed
- Illicit drug or alcohol abuse within past 12 months
- Prior solid organ transplant within 60 months requiring immunosuppression
- Receipt of live-virus vaccine within 28 days before or during study
- Allergic reactions to similar compounds
- History of other malignancies affecting study compliance except certain treated skin, cervical, prostate, breast cancers
- Major surgery within 4 weeks prior to start of treatment
- Known or suspected chronic active Epstein-Barr viral infection
- History of hemophagocytic lymphohistiocytosis or progressive multifocal leukoencephalopathy
- Malabsorption or allergy to xanthine oxidase inhibitors or rasburicase
- Positive hepatitis C or active hepatitis B infection
- Known active HIV infection unless well-controlled on therapy
- Significant cardiovascular disease or recent myocardial infarction
- Active infections or recent major infections within 4 weeks
- Suspected or latent tuberculosis
- Pregnant or breastfeeding females
- Uncontrolled autoimmune diseases or recent immunosuppressive treatment
- Primary or secondary central nervous system lymphoma or disease
- Clinically significant liver cirrhosis
- Any condition contraindicating participation or compliance concerns as judged by investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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