Actively Recruiting
Glofitamab Combined With Lenalidomide in High Risk Patients With Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With a BTK Inhibitor
Led by Peking University Third Hospital · Updated on 2026-03-10
43
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of glofitamab and lenalidomide in patients with high-risk relapsed or refractory Mantle Cell Lymphoma (MCL) who have previously been treated with a BTK inhibitor. This phase 2, single-arm, open-label, multi-center clinical study aims to assess the best overall response rate (BOR) at the end of induction, along with safety profiles and potential biomarkers predicting treatment effects in this patient group. The treatment involves administering glofitamab intravenously along with oral lenalidomide taken by the patient. Before starting glofitamab, patients receive two intravenous doses of obinutuzumab as a pretreatment. Patients must have received at least one prior systemic therapy including a BTK inhibitor and show at least one high-risk feature such as blastoid/pleomorphic variants, bulky disease, failure to achieve complete response with first-line treatment, or early disease progression. Participants will undergo assessments including PET/CT scans evaluated by Lugano criteria to measure response. Researchers will monitor efficacy outcomes like overall response rate, complete response rate, duration of response, progression-free survival, and overall survival over up to 48 months. Safety monitoring and biomarker analysis, including circulating tumor DNA and metabolic tumor volume, will also occur during the study, which spans from screening through treatment and follow-up.
CONDITIONS
Brief Title
Glofitamab Combined With Lenalidomide in High Risk Patients With Relapsed or Refractory Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent forms
- Age between 18 and 80 years
- Eastern Cooperative Oncology Group performance status of 2 or less
- Diagnosis of Mantle Cell Lymphoma confirmed by histologic assessment
- Previously treated with at least one prior systemic therapy including a BTK inhibitor
- BTK inhibitor exposure includes failure or intolerance
- Presence of at least one high-risk feature: blastoid/pleomorphic variants, Ki67 ≥50%, TP53 mutation or deletion, bulky disease (lesion ≥7.5 cm), failure to achieve complete response with first-line treatment, early disease progression (POD24), or relapse/refractory after more than 3 lines of treatment
- Measurable lesions on imaging of at least 1.5 cm
- Adequate liver function with specified bilirubin and liver enzyme limits
You will not qualify if you...
- Currently enrolled in other interventional or non-interventional relapsed/refractory Mantle Cell Lymphoma clinical trials
- Receiving immunosuppressive treatment for other diseases
- Previous treatment with lenalidomide
- Diagnosis of other malignant tumors within the past 3 years
- Considered unsuitable by the researcher for participation
- Serious mental or neurological disorders affecting consent or safety monitoring
- History of major cardiovascular disease or recent myocardial infarction or unstable heart conditions within 6 months
- Recent major surgery within 4 weeks prior to first cycle
- Active autoimmune diseases poorly controlled
- Active infections including bacterial, fungal, or viral infections within 7 days before starting treatment
- Positive SARS-CoV-2 PCR test within 7 days before enrollment
- Positive hepatitis B surface antigen test unless controlled with undetectable DNA and monitoring
- Positive hepatitis C antibody unless PCR negative for HCV RNA
- History of severe deep vein thrombosis or pulmonary embolism within 6 months
- Inability to be followed up during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive treatment with glofitamab combined with lenalidomide to evaluate efficacy and safety in high-risk relapsed or refractory Mantle Cell Lymphoma.
Visits scheduled according to treatment cycles during the induction period
Duration - Up to 24 months after treatment
Participants are monitored for long-term efficacy and safety outcomes after treatment ends, including response duration and survival.
Periodic visits for up to 24 months post-treatment
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
Research Team
H
Hongmei Jing
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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