Actively Recruiting
Glofitamab Combined With Lenalidomide in High Risk Patients With Relapsed or Refractory Mantle Cell Lymphoma
Led by Peking University Third Hospital · Updated on 2026-03-10
43
Participants Needed
1
Research Sites
228 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A single-arm, open-label, multi-center clinical study of glofitamab combined with lenalidomide in high risk patients with relapsed or refractory Mantle Cell Lymphoma previously treated with a BTK Inhibitor. Patients will be eligible if they have received one or more prior lines of therapy, one of which must have been a BTKi. Patients will be enrolled according to a Simon two-stage design, with early stop criteria for lack of efficacy. Glofitamab will be administered intravenously and lenalidomide will be self-administered orally. Obinutuzumab pretreatment will be administered intravenously as 2 doses of 1000 mg prior to glofitamab initiation. The primary endpoint is BOR at the end of induction, evaluated by PET/CT according to Lugano criteria during study enrolment. The primary objective is to evaluate the best objective response rate (BOR) at the end of induction of the combination of glofitamab and lenalidomide.
CONDITIONS
Official 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 form
- Age between 18 and 80 years
- Eastern Cooperative Oncology Group performance status of 2 or less
- Diagnosis of Mantle Cell Lymphoma confirmed by tissue assessment
- Previously treated with at least one prior systemic therapy for Mantle Cell Lymphoma
- Prior treatment must include a BTK inhibitor (e.g., ibrutinib, zanubrutinib, obrutinib, acalabrutinib)
- Patients with BTK inhibitor failure or intolerance
- At least one high-risk feature: blastoid/pleomorphic variant, Ki67 ≥50%, TP53 mutation or deletion, bulky disease ≥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 ≥1.5 cm on imaging (MRI, CT, or PET-CT)
- Adequate liver function: total bilirubin ≤3 times upper limit of normal (unless Gilbert's disease), AST ≤5 times upper limit of normal, ALT ≤5 times upper limit of normal
You will not qualify if you...
- Currently enrolled in other ongoing clinical trials for relapsed or refractory Mantle Cell Lymphoma
- Receiving immunosuppressive treatment for other diseases
- Prior treatment with lenalidomide
- Diagnosis of other malignant tumors within the past 3 years
- Considered unsuitable for the study by the investigator
- Serious mental or neurological disorders affecting informed consent or reporting of side effects
- History of major cardiovascular disease such as severe heart failure, recent myocardial infarction, unstable arrhythmia, or unstable angina within 6 months
- Major surgery within 4 weeks before starting treatment
- Active autoimmune diseases not well controlled
- Any active infection within 7 days before starting treatment
- Positive COVID-19 PCR test within 7 days prior to enrollment
- Positive test for chronic hepatitis B infection unless HBV DNA is undetectable and patient agrees to monitoring
- Positive test for hepatitis C antibody unless PCR test for HCV RNA is negative
- 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
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
Research Team
H
Hongmei Jing
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here